Admin Microbiology, SOP

SOP For Microbial Culture Management

A microbial culture (microbiological culture) is a procedure of growing microbial organisms (reproduction) by allowing them to breed in programmed culture medium under controlled laboratory conditions.

Microbial cultures are initial and basic diagnostic methods used as a research tool in molecular biology.

Microbial Culture Management

Standard Operating Procedure (SOP)

PURPOSE:

  • To lay down the procedure for the management of microbial cultures.

SCOPE:

  • This Standard Operating Procedure is applicable at Microbiology Department.

PROCEDURE FOR MICROBIAL CULTURING

  • Procurement of Cultures:
    • Prepare the list of ATCC / NCTC / NCYC / MTCC cultures required in the Microbiology section as per the details mentioned in Annexure-1.
    • Raise the purchase requisition for the cultures for procurement.
    • Procure the required cultures once in a year.
    • All cultures shall be procured from the authorized sources with certificate-based on permissible subculturing periods.
    • Ensure that the cultures shall not be more than 2 passages removed from the reference.
    • Upon receipt of the cultures, enter the details along with in house identification no.  in culture inward record as per Annexure-2.
    • Store these cultures in the refrigerator between 2º-8ºC or as per manufacturer recommendation.
    • For Example, E. coli received on 01/10/20 then given in house number should be E.coli 011020.

  • Reconstitution of Freeze-Dried Cultures:
    • Sanitized the surface of ampoule or vial or slant or loops using 70 % IPA.
    • Transfer the ampoule or vial or slant or loops under LAF/Biosafety cabinet and open the culture aseptically.
    • Add 0.5 ml to 1.0 ml of sterile water to the vial/ampoule/ slant to reconstituting the lyophilized / slant cultures or reconstitute the cultures as per the recommendation of the provider.
    • This culture will serve as mother Culture.
    • Record the details in Culture Maintenance Record as per Annexure-3.
  • Revival and Maintenance of Cultures:
    • Streak the mother culture on agar plates for confirmation of purity as per SOP for Isolation and identification of microorganisms (Annexure-4) or
    • Direct by automated identification system and simultaneously inoculate the total content of vial/ ampoule in 100 ml of sterilized Soya bean casein digest medium.
    • After transfer the mother culture in to the medium,
    • Dispose the remaining content and vial as per current version of SOP for Disposal of used media and cultures. and record the details in Annexure-8.
    • Use agar plate for purity check and
    • Use the liquid medium for preparation of Seed lot cultures.
    • Incubate the media containing
    • Bacteria (Cultures of Bacteria) at 32.5 ± 2.5º C for 24-48 hrs,
    • Molds (Cultures of Molds) at 22.5± 2.5º C for 72-120 hrs and
    • Yeasts (Cultures of Yeasts) at 22.5 ± 2.5º C for 24- 48 hrs.
    • Media and incubation conditions shall be followed for different cultures as recommended in Annexure-1.
    • After completion of incubation check the purity as per SOP on Isolation and identification of microorganisms of
    • Culture by colonial characteristics,
    • Microscopic examination,
    • Staining and
    • Biochemical characterization or
    • through automated identification System (BD Phoenix).
    • Add 10% v/v sterile glycerol in culture suspension in 1:1 ratio, mix well and dispense 2-3 ml into  the sterile cryo vial prepare 14 such vials which serves as Seed lot Culture (SLC).
    • Mark culture ID number as SLC-1, SLC-2, and SLC-3 and so on and store the cryo vials (Cryoprotective medium) at -30°C or below until use.
    • Label each cryo vial of SLC with the details like (as per the Annexure-6.)
    • Name of culture,
    • Strain no.,
    • Passage no.,
    • Culture ID.
    • Date of subculturing,
    • Sub cultured by and
    • Use before 
    • Use 12 cryovials of seed lot culture for subculturing up to 12 months (yearly) and Keep 2 cryovials as a stock which shall be used if any vial gets damaged or spillage.
    • Ensure that the cryovials shall not be used after one year.
    • Discard the remaining two cryovials after completion of yearly subculturing as per the current version of SOP on Disposal of used media and cultures.
  • Subculturing: (Microbial Culture)
    • Maintain the cultures as per the Schematic Flow for Subculturing as per Annexure-5.
    • For first-month subculture streak five slants of agar medium from the cryovial of SLC-1 and mark culture ID numbers as
    • 1.0            SLC-1WC-1,
    • 2.0            SLC-1WC-2,
    • 3.0            SLC-1 WC-3,
    • 4.0            SLC-1WC-4, and
    • 5.0            SLC-1WC-5.

    • Simultaneously streak on the plates of agar medium for purity check as per SOP for “Isolation and identification of microorganisms” of culture by
    • Colonial characteristics,
    • Microscopic examination,
    • Staining and
    • Biochemical characterization or
    • through an automated identification System (BD Phoenix).
    • Incubate the slants and plates containing cultures of
    • Bacteria at 32.5±2.5ºC for 24-48 hrs,
    • Molds at 22.5± 2.5ºC for 72-120 hrs. and
    • Yeast at 22.5± 2.5ºC for 24- 48 hrs.
    • When proper growth observed on the transferred slants discard SLC-1 following the current version of SOP on “Disposal of used media and cultures” and record the details in Annexure-8.
    • Label each slant of working culture with the details like
    • Name of culture,
    • Strain no.,
    • Passage no.,
    • Seed lot culture no.,
    • Culture ID.,
    • Date of sub culturing,
    • Sub cultured by and
    • Use before as per Annexure-7 and
    • Store the working cultures at 2 – 8 ºC.
    • Use one working culture for each week for routine lab work for up to one month.

                              Discard the working culture at the end of the week or before using a new working culture.

    • The fifth working culture shall also be discarded at the end of the month if it remains unused and details shall be recorded in Annexure-8.
    • Start the same procedure with SLC-2 and so on, well before completing the cycle of previous SLC to get the working cultures ready to use for next month.
    • Check the purity of seed lot culture and working culture as per SOP on Isolation and identification of microorganisms  at the time of use by
    • Colonial characteristics,
    • Microscopic examination,
    • Staining and
    • Biochemical examination and
    • Record the observations in Annexure-4 or
    • through an automated identification system (BD Phoenix).
    • Record the details of subculturing in Annexure-3 at every step of sub-culturing.
    • Tentative Schedule for Maintenance of Microbial Cultures shall be prepared for subculturing at the time of the first revival of new cultures as per Annexure-9.
    • Ensure that the inoculates used shall not be more than 5 passages removed from the certified reference cultures.
  • Process Description: Live Cultures
    • During working with live cultures always use Gloves.
    • Segregate all live cultures from areas used for sample testing and optimally, handled in a different area of the laboratory within a Biosafety Cabinet.
    • Perform positive control dilutions and inoculation in a biological safety hood/cabinet.
    • Seal Agar plates containing fungal cultures with para-film to prevent spread of spores.
    • Surfaces in areas where a live culture plate, tube, bottle, pellet, etc., was opened shall be sanitized immediately after use by using an approved sanitizer for the appropriate contact time.
  • ANNEXURES:
    • List of Microbial Cultures. (Annexure-1)
    • Microbial Culture Inward Record. (Annexure-2)
    • Culture Maintenance Record. (Annexure-3)
    • Purity Check of Microbial Culture. (Annexure-4)
    • Schematic flow for Sub-Culturing. (Annexure-5)
    • Seed Lot Culture Label. (Annexure-6)
    • Working Culture Label. (Annexure-7)
    • Culture Disposal Record. (Annexure-8)
    • Schedule for Maintenance of Microbial Cultures. (Annexure-9)

Click to read article : Laminar Air flow (LAF) – Operation, Cleaning and Qualification

Schematic flow for Sub-Culturing. (Annexure-5)

Schematic Flow for Sub Culturing

Seed Lot Culture Label. (Annexure-6)

Seed Lot Culture

Working Culture Label. (Annexure-7)

working culture

Schedule for Maintenance of Microbial Cultures. (Annexure-9)

Schedule

Admin Microbiology, SOP

SOP on Laminar Air flow (LAF) – Operation, Cleaning and Qualification

LAF : Laminar Air Flow –  Airflow which is linear and positive up to working surfaces and thus prevents contamination of surrounding viable/ non viable particulate matter in aseptic handling. The Operation, Cleaning, Maintenance and Qualification of Laminar Air Flow (LAF) shall discussed in below SOP.

Laminar Air flow (LAF) – Operation, Cleaning and Qualification

Purpose:

  • To lay down the procedure for the operation, cleaning, maintenance and qualification of the Laminar Air Flow.

Scope:

  • This Standard Operating Procedure is applicable at Microbiology section / Sterile Area where Laminar Air Flow (LAF) installed.
  • Definition of Terms :
    • Standard Operating Procedure (SOP): A written authorized procedure, which gives instructions for performing operations.
    • LAF: Laminar Air Flow: Airflow which is linear and positive up to working surfaces and thus prevents contamination of surrounding viable/ non viable particulate matter in aseptic handling.

Procedure (Laminar Air Flow – LAF):

  • Cleaning of  Laminar Air Flow (LAF)
    • First of all, Turn OFF the switch of the Air Flow and UV of LAF unit (if ON).
    • Then clean properly the working chamber from ceiling, followed by side glass and then the platform of the chamber with 70% IPA.
    • After that spray 70% IPA and switch off the visible light and then switch ON the UV light till to start the next operation.
    • Finally Routine culture handling shall perform at the end of the Sample testing only.
  • Laminar Air Flow Operation (LAF-Operation)
    • Switch ON the mains.
    • Ensure that the manometer is showing Zero reading before starting.
    • Turn the switch of the Air Flow to ON position. Ensure that the differential pressure is within the limit of 8 to 15 mm of water and record the observation in Annexure-2.
    • Turn the switch of the UV lights to ON position.
    • After 30 minutes switch OFF the UV and switch ON the Visible light. Enter the burning hour details of UV in Annexure-2.
    • Now perform the activities.

                Note:   Replace the UV Light after 999 Burning hrs.

  • Pre-Filter Cleaning of Laminar Air Flow (LAF) :
    • First of all, Switch ‘OFF’ the mains of LAF, loosen the bolts properly and take out the Prefilter slowly, without any jerks from the LAF.
    • Then Shift the filter to wash area outside microbiology analysis room where cleaning is to be done.
    • Ensure the left out opening of the Prefilter on the LAF unit shall covered with butter paper in order to prevent dust as well as the outside air moving inside the LAF unit.
    • First de-dust the filter properly with the help of dry, oil free compressed air. The compressed air shall be forced properly to prefilter of LAF otherwise it will damage the filter.
    • After dedusting, clean the prefilter properly 2 -3 times with Purified water. Allow all the water to drain completely after water cleaning.
    • Then dry the prefilter after proper draining in a clean dry environment free from the dust; otherwise the chances of contamination in the sterile environment may arise or it may decrease the efficiency of the prefilter. Do not dry the prefilter in an open environment.
    • Spray 70% IPA solution filtered through 0.45 m filter and mop SS attachment of the prefilter properly before transferring inside the microbiology analysis area.
    • Affix the cleaned prefilter properly in appropriate place by removing the butter paper cover and tighten the bolts properly.
    • Check the Differential Pressure in Laminar Air Flow (LAF) :
    • Then Place the prefilter at its position. Switch on the Laminar Air Flow (LAF) unit. Check the differential pressure is in between 8 to 15 mm of water gauge.
    • If pressure reading on manometer is not achieved, put a status label ‘Under Maintenance’ & intimate the Maintenance Department for necessary action.
    • Prefilter of the Laminar Air Flow (LAF) benches shall clean once in three months In order to retain the efficiency of the HEPA filter and proper working of LAF.
    • After the Prefilter is fixed, the area shall clean properly followed by fogging as per SOP of “Fumigation of Microbiology” before using the instrument as well as the area for operation.
    • Cleaning record is to maintain as per Annexure-1.
    • Clean the Pre filter at the frequency of 3 months ± 7 days.
  • Qualification of Laminar Air Flow (LAF) :
    • Frequency:
      • Once in six months ±15 days.
    • The qualification of LAF required:
      • If any failure observed during routine monitoring.
      • In case of breakdown, maintenance, preventive maintenance.
      • In case of change in installation location.
    • Procedure of LAF Qualification :
      • Following tests are performed during qualification and results are within acceptance criteria.
        • Air velocity test:
          • Ensure that air velocity of the LAF is checked using calibrated anemometer.
          • Acceptance criteria: The velocity of the laminar air should be within 90 + 20 % ft/min.
        • Particulate count test :
          • Ensure that particle count of the work station is done using a calibrated air borne particulate matter counter. 1 m3 of air sample is collected per filter.
    • Acceptance criteria:
      • ≥ 0.5µ particles: NMT 3500 particles per m3 ≥ 5.0µ  particles : 00 (Nil / Absent) particles per m3
  • HEPA Filter integrity test / HEPA Filter leak test (Laminar Air Flow – LAF):
  • Ensure that the filter integrity test of the HEPA filter done using PAO (Poly Alfa Olefin).
  • Acceptance criteria:
    • The penetration level should less than 0.01%.
    • In case of detection of rupture of fine filter, seal the rupture with soft silicone sealant.
    • Restrict the silicone sealing to not more than 3.0% of the area of the filter and not more than 3.0 sq. inch of single patch.
  • Qualification shall perform by external agency if facility not available at location.
  • After Completion of Qualification write the details and pest as per Annexure-3.

For basics of Laminar air flow Click here

Cleaning Record of Prefilter – LAF

CLEANING RECORD OF PREFILTER-LAF

Laminar Air Flow Operation Record

Laminar Air Flow Operation Record

Visiters also reading : 

A)       Isolation and Identification of Microorganisms

B)       Laminar Airflow (LAF) – Operation, Cleaning, and Qualification

  • References:
    • Operation Manual  of Laminar Air Flow (LAF) for Operation, Performance check, Sanitization and Qualification.
  • Annexures:
    • Annexure-1 : Cleaning Record of Prefilter
    • Annexure-2 : Laminar Air Flow operation Record.
    • Annexure-3 : Qualification Status Label
Admin Quality Control, SOP

SOP for Handling of Laboratory Reagents

Standard Operating Procedure (SOP) for Receipt, Storage, and Handling of Laboratory Reagents, Buffers, Solvents, Glasswares and other consumables in QC.

Receipt, Storage, and Handling of Laboratory ReagentsPurpose :

  • The purpose of this SOP ( Standard Operating Procedure) is to describe the procedure for the receipt, storage, and handling of laboratory reagents.

Scope :

  • This procedure is applicable to laboratory reagents used at Quality Control Department in the pharmaceutical manufacturing plant.

Responsibilities : (Laboratory Reagents)

  • Analyst :
  • To provide information about chemical/reagent for procurement and follow the procedure as per the SOP.
  • To maintain the related documents as per the SOP.
  • Quality Control Head or Designee :
  • To procure the required chemical/reagent.
  • Receiving of procured chemicals in proper condition.
  • Store the received chemicals as per their required storage condition
  • Handling of Chemicals with proper safety as per the respective SDS.
  • Perform the documentation as per the SOP.
  • Provide training to the concern persons before the implementation of the SOP.
  • Quality Assurance :
  • To check the SOP.
  • The implementation of the system as per the SOP.
  • Regulatory Affairs Quality Head and Plant Head :
  • To review and approve the SOP.

Abbreviations and Definition of Terms : (Laboratory Reagents)

  • Abbreviations :
  • ETP: Effluent Treatment Plant.
  • PPE: Personal Protective Equipments
  • SDS: Safety Data Sheet.
  • SOP: Standard Operating Procedure
  • NA: Not Applicable
  • Definition of terms: NA

Procedure for Handling of Laboratory Reagents :

  • Laboratory Reagents Procurement Procedure :
  • The analyst shall inform the designated QC person in case of the requirement of any Laboratory reagent /chemicals.
  • The analyst shall mention the details of the required Laboratory chemical/ reagent in the Reagent requirement register as per  Annexure-2.
  • The designated QC person shall inform the supplier about the desired chemical and its required quantity for its procurement.
  • Laboratory Reagents Receiving Procedure :
  • On receipt of the reagents/chemicals, the designee from QC shall verify it against the reagent requirement /issuance register.
  • The designed QC person shall observe the physical condition of the container/bottles/packs before receiving the reagent/ chemicals.
  • If any discrepancy is observed (e,g damaged container, improper storage condition, quantity mismatch, etc.) the QC person shall immediately inform to Head QC or designee and return the material to the supplier.
  • After the required laboratory reagent/chemical is received. its receipt and stock details shall be maintained as per Annexure- 3 by the designed QC person.
  • After receipt of Laboratory glasswares, its receipt and stock details shall be maintained as per Annexure- 4 by the designed QC person.
  • QC person shall paste the label on the laboratory reagent/container as shown in Annexure -1 and put the details of  “Date of Receipt along with the signature.
  • The analyst shall put the date of “First time opened on” along with the sign and assign an expiry date to the chemicals.
  • The expiry date for solid laboratory reagents, solvents and acids shall be as provided by the manufacturer.
  • In case the expiry date is not provided by the manufacturer, then the expiry date shall be assigned as three years from the date of opening.
  • The designated person shall arrange SDS and certificate of analysis if required.
  • Storage of Laboratory Chemicals / Reagents :
  • Store the chemicals/reagents as per the manufacturer’s instructions on the container considering safety precautions.
  • If the manufacturer does not mention any recommended storage condition, store the chemicals/reagents in a designated reagent/chemical storage room controlled at 25°C ± 2°C.
  • In the case of general reagent, where specific storage condition is not required, shall be stored at ambient temperature.
  • If the recommended storage condition of any laboratory reagent is below 15°C, it shall be stored in the refrigerator.
  • In the case where the recommended storage condition of any laboratory reagent is below 0°C, store in a deep freezer.
  • Handle the chemical/ reagent with proper precautions as per its SDS.
  • Acid corrosive chemical bottles/containers shall be opened after wearing proper PPE’s.
  • General Usage Procedure of Laboratory Reagents / Chemicals:
  • The analyst shall take the required reagent for usage from its designed storage place/ chemical store.
  • The analyst shall put the date of opening with signature and expiry date on the label affixed at the time of receipt.
  • If the label is not affixed, Do not use such reagents.
  • The analyst shall codify the reagents and arrange them in alphabetical order on the cupboard of the working table of the respective location.
  • Do the coding of reagents coding at the time of its receipt, the Designated person shall give the specific code to the reagent and maintain the list of reagents with code.
  • Code: the first alphabet of the reagents with serial number
    • e.g. 3-Aminopyridine Code: A01
    • Aluminum GR Code: A02
    • Barium chloride 2-hydrate GR Code: B01
    • Zinc Acetate extra Pure Code: Z01
  • After opening the reagent bottle, if any abnormal observation is found in the physical appearance of reagent, the analyst shall immediately inform to Head QC or designee.
  • Discard such reagents/chemicals as per the procedure defined in the SOP for  “ Disposal of waste generated in Quality control” by taking proper precautions as per its respective SDS.
  • The analyst shall use a new chemical/reagent bottle.
  • After using the required reagent/ chemical, Keep the bottle/container back to its designed place.
  • Maintain the minimum stock of laboratory reagents/chemicals to prevent any delay in the analysis.
  • Precautions during Handling of Laboratory Reagents:
  • Always assure the intactness of the reagent bottle before use.
  • Always check the physical condition and appearance of the reagent before use
  • Ensure the expiry date of a particular reagent before using it. Do not use any reagents after the expiry date as mentioned on the label of the bottle/container.
  • Tighten the mouth of the reagent container both before and after use.
  • Always use suitable PPE’s (like hand gloves, mask, goggle, etc.) required as per the SDS of the chemical/reagent.
  • Always refer to SDS and handling precautions while handling poisonous and toxic chemicals/reagents.
  • Consumption of Acetic Anhydride :
  • Controlled usage of  Acetic Anhydride.
  • Keep Acetic Anhydride under control and secured with lock and key.
  • Destruction Procedure of Laboratory Reagents:
  • If the reagents are left after the expiry date is over, Destroy the remaining quantity as per the procedure mentioned in the SOP for “ Disposal of waste generated in Quality Control.
  • Destruction of Acids :
  • Take plenty of water in a container and add the acid slowly with stirring through sides of the beaker.
  • If the temperature is observed in the container, add more water, cool it and drain it.

Note: Some reagents/chemicals/acids may be reactive when treated with water.  Hence, it mandatory to refer to the SDS of the particular reagent before following any discardation procedure. 

Sticker Label at the time of receipt (Annexure -1)

Sticker - Laboratory Reagents

Reagent Requirement and Issuance Register (Annexure -2)

Annexure 2

Receipt and Stock detail of Chemical/Reagent (Annexure -3)

Name of Material:

Code No.:                                                                                                                     Sr.

No. Date of

Receipt Received

Qty. Withdraw

Qty. Withdrawal

By and Date Balance

Qty. Checked

By

Remark

Receipt and Stock detail of Laboratory Glasswares (Annexure -4)

Name of Glassware :

The volume of Glassware:

Sr. No. Date of Receipt Received qty. Received by. Checked By

Remark

References and Annexures:

  • References :
  • In House.
  • SOP for Disposal of waste generated in Quality Control
  • Annexures :
  • Sticker Label at the time of receipt (Annexure -1)
  • Reagent Requirement and Issuance Register (Annexure -2)
  • Receipt and Stock detail of Chemical/Reagent (Annexure -3)
  • Receipt and Stock detail of Laboratory Glasswares (Annexure -4)
Admin SOP

SOP for Polarimeter

Purpose:

  • The purpose of this SOP is to describe the procedure for operation, cleaning, and calibration of the polarimeter.

   Scope:

  • This SOP  is applicable to the polarimeter available in the Quality control laboratory at the pharmaceutical drug manufacturing plant.
  • Make: …
  • Model:….

Responsibilities – SOP for Polarimeter:

  • The Analyst shall be responsible for:
  • Operate the instrument as per SOP.
  • Calibrate the instrument as per SOP.
  • Maintain the calibration records.
  • Head QC or Designee shall be responsible for:
  • Check the SOP.
  • Impart the training to all concerned persons before the implementation of SOP.
  • Ensure that Operation & Calibration of the instrument is carried out as per SOP.
  • Execute the Out of Calibration (OOC) in case of calibration failure and breakdown and intimate the same to Quality Head.
  • Initiate repairs or breakdown and to make alternative arrangements during the status of under maintenance.
  • Ensure proper documentation as per SOP.
  • Quality Assurance shall be responsible for:
  • Check the SOP.
  • Ensure the implementation of the system as per SOP.
  • Quality Head shall be responsible for:
  • Review and approve the SOP.
  • Authorize the Out of Calibration investigation.
  • Ensure that the system is implemented.

Procedure for Handling and Calibration of Polarimeter:

  • Definition of terms :
  • Optical Rotation :
  • The optical rotation of a substance or liquid is the angle through which the plane of polarization is rotated when polarized light passes through the substance or liquid/solution of the substance.
  • Such substances are said to be optically active.
  • If the plane of polarization is rotated to clockwise direction then it is called dextrorotatory (+) and if it is anticlockwise then called levorotatory (-).
  • Specific Optical Rotation (SOR) :
  • For solid samples :  
  • A specific optical rotation of a substance is defined as the angle of rotation of the plane of polarization at the wavelength of the D line of Sodium (λ=589.3 nm)measured at 25°C (unless otherwise specified)calculated with reference to a 1-dm thick layer of a solution containing1g of a substance per ml.
  •  For liquid sample: A specific optical rotation of a liquid substance is defined as the angle of rotation of the plane of polarization at the wave-length of the D line of sodium (λ=589.3 nm) measured at 25°C (unless otherwise specified), calculated with reference to a 1-dm thick layer of a solution and its density.
  • General Procedure – Polarimeter:
  • For the entry of usage of the instrument, follow the SOP on “Instrument/equipment usage logbook.
  • In case of any maintenance of the polarimeter instrument, follow SOP on “Maintenance of laboratory instrument.
  • Maintain the internal and third-party calibration schedule for the instrument as per SOP.
  • In case of noticing any calibration result out of the specified limit, follow the SOP of “Handling Out of Calibration.
  • Precautions during handling of Polarimeter:
  • Allow sufficient time to warm up the lamp before use
  • Optical rotation should be determined within 30 minutes of preparation, unless otherwise specified.
  • Maintain the required temperature during the optical rotation analysis.
  • Before start of the analysis this shall be conform that the instrument, and polarimeter tube is clean and no spillage or residues of the previous product, if present then need to clean.
  • Polarimeter tube should be clean with the diluent and then rinse with the small amount of sample.
  • Then fill it with the required solution in such a way that no air bubble remains in the path of polarized light.
  • Maintain the cleanliness of glass tube and avoid over-tightening of end screw caps.
  • Set the bubble at the center (curvature) to align the instrument properly.
  • The temperature probe shall keep clean after analysis to avoid the contamination which may affect the result.
  • Make sure that the sample chamber is empty and its lid is closed during the analysis and after completion of analysis.
  • The sample shall be measured using the same angular orientation of the cell as that of the blank.
  • While changing samples from one to another, wash the sample cell 2-3 times with the sample to remove any previous sample residue.
  • To hold the sample cell in the cell holder, set it in the same position facing the same direction. The data cannot be reproduced if the position/direction is changed.
  • Before shutting, make sure that the sample chamber is empty.
  • Turn OFF the power switch on the rear panel of the polarimeter.
  • Clean and air dry the sample cell for storage.
  • Allow sufficient time to warm up the lamp before use.
  • Maintain the required temperature during the optical rotation measurement of blank and sample solution.
  • Liquid and solutions of solids must be clear.
  • Cleaning procedure of Polarimeter:
  • The Analyst shall clean the Polarimeter and its surrounding with the dry cloth before and after use.
  • If the solution spills on the instrument then clean it immediately with the dry cloth.
  • If required clean the instrument with approved detergent (e.g. 1% Hemtop) followed by purified water and wipe with the dry cloth.
  • Lens cleaning shall be done by using lint-free tissue paper.
  • After every analysis cleaning of the glass tube and temperature probe shall be done by using the solvent in which the test solution prepared and then wash with purified water and finally rinse with methanol.
  • Operation Procedure of Jasco make Polarimeter:
  • Check the polarimeter calibration status of the instrument.
  • Press the power switch “ON” located on the front panel.
  • The power lamp located on the front right side of the instrument lights.
  • Now double click on the “Polarimeter” icon on the desktop.
  • Enter the user name and password and click on the login button.
Polarimeter - Login Page
  • After the login, click on the standard measurement option.
  • The system begins to initialize which requires about five minutes.
  • Click on the ‘parameter’ short cut or select it from the measure tab and enter the measurement parameters accordingly.
  • Enter the integration time in seconds.
  • If the time entered is 5 sec then the test shall be performed for 5 seconds.
  • Enter the repeat time by using the keyboard in numbers.
  • If the repeat time is given 5, then the instrument will perform the test 5 times.
  • Enter the interval time in seconds. If the time entered is 5 seconds then it will take 5 sec interval after every repeat reading.
  • Enter the cell length in mm.
  • The default value is 100 mm.
  • Enter the sample name, comment and save the parameter.
  • To zero set open the sample compartment and check that it is empty and then close it, select ‘zero clear’ from the measurement menu.
  • To take the blank reading, open the cover of the instrument.
  • Fill the blank (diluent) in the cell tube and hold the cell in the sample chamber by opening the lid of the instrument.
  • Dip the temperature sensor in the sample cell.
  • The temperature of sample or blank to be measured should be within the specified range, make sure that the mode is selected as ‘Optical rotation’ for ‘Blank’ in the parameters, click on the ‘Blank’ button and select ‘measure’.
  • For taking the measurement of the sample click on the parameters and select the mode as required, if Specific Optical Rotation (SOR), Concentration or Optical Rotation (OR) value is required then select accordingly and save the parameters.
Polarimeter - Parameter Setup
  • Click on the ‘Sample’ button and enter the sample name and comment if any, and select measure after the measurement is over, then save the data.
  • For printing the data, go to the ‘Spectra Manager CFR’ window and select ”Polarimeter Analysis’ on the left -hand side of the window.
  • Select the sample file by double-clicking on it, select print.
  • Filter Changing (Wavelength Set):
  • Normally, the Sodium (Na) lamp is used, the wavelength set (filter) is 589nm.
  • To check or change the wavelength, open the lid of the filter unit as shown in the figure below, to the left of the sample chamber.
  • Remove the filter (589nm) and place it safely.
  • Insert the filter having wavelength set 436nm to the filter unit.
  • In some cases, Use the Mercury (Hg) lamp as per the requirement of product.
  • The wavelength set (filter) required is 436nm.
  • To replace the wavelength set (filter) 436nm to wavelength set (filter) 589nm, follow the same procedure.
  • Light Source Change:
  • To change the light source select the ‘light source’ button on the standard measurement window.
  • Click on the Hg or the Na lamp with yellow mark first to deactivate the lamp and select the lamp which is required for analysis, the status of the lamp is indicated by the yellow color, the yellow color indicates that the lamp is activated.

Calibration Procedure of Polarimeter

  • Polarimeter Calibration Methods:
  • Calibration can be done either by preparing calibration solutions of sucrose/ fructose or by using Quartz plates.
  • Polarimeter Calibration frequency and standard :
  • Quarterly ± 7 days or immediately after maintenance.
  • Temperature sensor (If applicable) shall be calibrated yearly once with an accuracy of ± 0.5°C.
  • Calibration shall be carried out after the following maintenance.
    • Change in lamp
    • Replacement
  • Calibration shall be carried out after relocation
  • For the Calibration of Polarimeter, it is recommended to use the certified standard like sucrose and fructose.
  • Alternatively, Polarimeter Calibration can be checked by using a polarization reference standard which consists of a plate of quartz (This standard is available, traceable to NIST, from Rudolph research analytical or from Rudolph Instrument).
  • Polarimeter Calibration check using Quartz Plate :
  • Calibration with the Quartz Plate is done by mounting the quartz plate in a holder perpendicular to the light path.
  • Polarimeter Calibration shall meet the value supplied by the manufacturer(traceable to NIST) for that applicable wavelength.
  • The observations of calibration using quartz plate shall be recorded in Annexure-1
  • Polarimeter Calibration check using the Sucrose solution ( Dextrorotatory range)for Mercury and Sodium Lamp :
  • Frequency: Quarterly± 7 days
  • Follow the calibration procedure for Mercury (Hg) lamp having wavelength set (filter) 436nm as well as Sodium(Na) lamp having wavelength set (filter) 589nm.
  • The acceptance criteria for SOR at 20.0°C for Mercury lamp and 25.0°C for sodium lamp are mentioned in the Polarimeter calibration template as per Annexure-2.
  • Dry the sucrose at 105°C for 2 hours.
  • Prepare a series of solutions having the concentration of 10.0%, 20.0% 30.0%, 40.0% and 50.0% w/v solution of anhydrous sucrose in purified water as specified in calibration template i.e Annexure-2.
  • Condition the sucrose solutions and the blank solution (diluent) at 20°C±0.5°C while using Mercury (Hg) lamp
  • Condition the sucrose solutions and the blank solution (diluent) at 25°C±0.5°C while using Sodium (Na) lamp.
  • Take the reading of purified water (diluent) as a blank and auto-zero the instrument.
  • Fill the tube with the sample solution of the specified concentration of sucrose.
  • Measure the SOR of all five solutions using 1-dm Polarimeter tube, by following the operation procedure.
  • Take five readings of each solution. Each reading should meet the acceptance criteria as per the manufacturers COA
  • Tabulate the results in the Polarimeter calibration template.
  • Note 1: If the visual polarimeter is employed, the average of five determinations, corrected for the reading of the same tube with a solvent i.e. purified water, is used.
  • Note 2: If the automatic polarimeter is employed then blank to be performed before sample analysis, to avoid the interference of blank in the sample result.
  • Plot a linearity curve of component concentration vs corresponding optical rotation. The coefficient of correlation shall be not less than 0.992.
  • Polarimeter Calibration check using Fructose solution (Levorotatory range) for Mercury and Sodium Lamp:
  • Frequency: Quarterly ± 7 days
  • Note: If the location does not have any sample with the specification in the Levorotatory range then calibration in the Levorotatory range is not required to be performed.
  • Follow the calibration procedure for Mercury (Hg) lamp having wavelength set (filter) 436nm as well as Sodium(Na) lamp having wavelength set (filter) 589nm.
  • The acceptance criteria for SOR at 20.0°C for Mercury lamp and 25.0°C for sodium lamp shall be as per manufacturer COA.
  • Polarimeter Calibration shall be performed as per Annexure-2.
  • In-general the observed optical rotation at 436 nm is about double that at 589 nm (Ref. USP <781> ).
  • Dry about 5 gm of Fructose in the vacuum oven at 70°C for 4 hours.
  • Solution Preparation for Polarimeter Calibration:
  • 10% w/v Fructose Solution: Weigh accurately (5gm, it should be as accurate as possible) of previously dried fructose and transfer it in a clean and dry 50 ml volumetric flask, dissolve it in 25 ml of purified water.
  • Make up the volume (50 ml) with purified water.
  • Follow the above calibration steps with fructose solution.
  • Re-calibration of Polarimeter:
  • If the equipment is subjected to severe mechanical shock or vibration.
  • If the equipment is relocated.
  • When there is any suspicion about the accuracy of the numbers measured when any of the optical components like bulb, PMT, filter, polarizer or analyzer shall be changed or replaced.

ANNEXURE 1

Format for Polarimeter Calibration Template (by Quartz Plate)

Instrument NameTemplate Issuance No.
ID No.Make /Model
LocationCalibration frequencyQuarterly ± 7 days
Calibrated onNext calibration due on

TABLE -A

Quartz Rotatory Plate ( Dextro rotatory range )Make/ Model :
Sr. No.TemperatureWavelengthActual ValueObserved ValueAcceptance Range (Actual value ± 0.5 %)
1589 nm
2436 nm

TABLE -B

Quartz Rotatory Plate ( Levo rotatory range )Make/ Model :
TemperatureWavelengthActual ValueObserved ValueAcceptance Range (Actual value ± 0.5 %)
589 nm
436 nm

(Note :- The Limits shall be as per the calibration certificate provided by the manufacturer.)

Remarks: The instrument is calibrated & qualified/ Out of calibration & not qualified for use.

Calibration type: Scheduled / Not scheduled (Reason: _________________________)

Calibrated by:Checked by:
Date:Date:

ANNEXURE 2

Format for Polarimeter Calibration Template (Chemical Test)

Instrument NameTemplate Issuance No.
ID No.Make /Model
LocationCalibration frequencyQuarterly ± 7 days
Calibrated onNext calibration due on

Mercury Lamp : By Sucrose Solution (Dextro-rotatory range)

  • Calibration Requirements:-
  • Lamp used _________ Mercury (Hg)
  • Filter (wavelength set) used ______________ 436 nm
  • Analytical Balance Code No.______________ Valid upto _________
  • Vacuum Oven Code No.______________ Valid upto _________
ChemicalsBatch No.Cal.Std.No.Make/GradeUse Before
Sucrose anhydrous
  • Procedure – Polarimeter Calibration:
  • Sucrose Solution Preparation:
  • Take the required quantity of ____________________________ sucrose anhydrous and dry it in an oven at ___________ 105°C for _________ 2 hours.(From ________ to ________ ).
  • Prepare a series of solutions having the concentration of 10.0%, 20.0%, 30.0%, 40.0% and 50.0% w/v solutions of sucrose in purified water as specified below:
  • 10% w/v Sucrose Solution:
  • Weigh accurately _________ 5.000gm (as accurate as possible) of ___________________ previously dried sucrose and transfer it in cleanand dry _________ 50 ml volumetric flask.
  • Dissolve it in 25ml of __________ purified water and dilute up to the volume with _________ purified water.
  • 20% w/v Sucrose Solution:
  • Weigh accurately _________ 10.000gm (as accurate as possible) of ___________________ previously dried sucrose and transfer it in clean and dry _________ 50 ml volumetric flask.
  • Dissolve it in 25ml of __________ purified water and dilute up to the volume with _________ purified water.
  • 30% w/v Sucrose Solution:
  • Weigh accurately _________ 15.000gm (as accurate as possible) of ___________________ previously dried sucrose and transfer it in clean and dry _________ 50 ml volumetric flask.
  • Dissolve it in 25ml of __________ purified water and dilute up to the volume with _________ purified water.
  • 40% w/v Sucrose Solution:
  • Weigh accurately _________ 20.000gm (as accurate as possible) of ___________________ previously dried sucrose and transfer it in clean and dry _________ 50 ml volumetric flask.
  • Dissolve it in 25ml of __________ purified water and dilute up to the volume with _________ purified water.
  • 50% w/v Sucrose Solution:
  • Weigh accurately _________ 25.000gm (as accurate as possible) of ___________________ previously dried sucrose and transfer it in clean and dry _________ 50 ml volumetric flask.
  • Dissolve it in 25ml of __________ purified water and dilute up to the volume with _________ purified water.
  • Measurement – Polarimeter Calibration:
  • Condition the sucrose solutions and the blank solution (diluent) (________________ purified water) at ____________ 20°C±0.5°C.
  • Take the reading of ____________________ purified water (diluent) as a blank and make it to auto zero.
  • Take the readings of all samples within 30 minutes of sample preparation.

Sodium Lamp : By Sucrose Solution

  • Calibration Requirements:
  • Lamp used _________ Sodium (Na)
  • Filter (wavelength set) used ______________ 589 nm
  • Analytical Balance Code No.______________ Valid upto _________
  • Vacuum Oven Code No.______________ Valid upto _________
ChemicalsBatch No.Cal.Std.No.Make/GradeUse Before
Sucrose anhydrous
  • Procedure for Polarimeter Calibration:
  • Sucrose Solution Preparation:
  • Take the required quantity of ____________________________ sucrose anhydrous and dry it in an oven at ___________ 105°C for _________ 2 hours (From ________ to ________ ).
  • Prepare a series of solution having the concentration of 10.0%, 20.0% , 30.0%,40.0% and 50.0% w/v solutions of sucrose in purified water as specified below:
  • 10% w/v Sucrose Solution:
  • Weigh accurately _________ 5.000gm (as accurate as possible) of ___________________ previously dried sucrose and transfer it in cleanand dry _________ 50 ml volumetric flask.
  • Dissolve it in 25ml of __________ purified water and dilute up to the volume with _________ purified water.
  • 20% w/v Sucrose Solution:
  • Weigh accurately _________ 10.000gm (as accurate as possible) of ___________________ previously dried sucrose and transfer it in clean and dry _________ 50 ml volumetric flask.
  • Dissolve it in 25ml of __________ purified water and dilute up to the volume with _________ purified water.
  • 30% w/v Sucrose Solution:
  • Weigh accurately _________ 15.000gm (as accurate as possible) of ___________________ previously dried sucrose and transfer it in clean and dry _________ 50 ml volumetric flask.
  • Dissolve it in 25ml of __________ purified water and dilute up to the volume with _________ purified water
  • 40% w/v Sucrose Solution:
  • Weigh accurately _________ 20.000gm (as accurate as possible) of ___________________ previously dried sucrose and transfer it in clean and dry _________ 50 ml volumetric flask.
  • Dissolve it in 25ml of __________ purified water and dilute up to the volume with _________ purified water.
  • 50% w/v Sucrose Solution:
  • Weigh accurately _________ 25.000gm (as accurate as possible) of ___________________ previously dried sucrose and transfer it in clean and dry _________ 50 ml volumetric flask.
  • Dissolve it in 25ml of __________ purified water and dilute up to the volume with _________ purified water.
  • Measurement – Polarimeter Calibration:
  • Condition the sucrose solutions and the blank solution (diluent) (________________ purified water) at ____________ 25°C±0.5°C.
  • Take the reading of ____________________ purified water (diluent) as a blank and make it to auto zero.
  • Take the readings of all sucrose solution within 30 minutes of sample preparation.
  • Fill the tube with the sample solution of the specified concentrations of sucrose respectively.
  • Measure the Specific optical rotation of all five solutions using 1-dm Polarimeter tube.
  • Take ________ five readings of each solution.
  • Each reading should meet the acceptance criteria as specified in the observation table.
  • Tabulate the results in the observation table.
  • Plot a linearity curve of component concentration vs corresponding optical rotation.
  • The coefficient of correlation shall be not less than 0.992.
Sr. No.Concentration of Sucrose (dried) (in %)Specific Optical Rotation at 25 °C ± 0.5°CSpecific Optical Rotation, SOR (in %) at 25°CCorrelation of coefficient (NLT 0.992)
Lamp  ______             SodiumFilter _________               589nm
12345Mean SOR (in %)
110+66.15° to +67.15°
220+66.03° to +67.03°
330+65.93° to +66.93°
440+65.83° to +66.83°
550+65.73° to +66.73°

Remarks: The instrument is calibrated & qualified/ Out of calibration & not qualified for use.

Calibration type: Scheduled / Not scheduled (Reason: _________________________)

Calibrated by:Checked by:
Date:Date:

Attachments (if any) :-

Mercury Lamp : By Fructose Solution

  • Calibration Requirements:
  • Lamp used _________ Mercury (Hg)
  • Filter (wavelength set) used ______________ 436 nm
  • Analytical Balance Code No______________ Valid upto _________
  • Vacuum Oven Code No______________ Valid upto _________
ChemicalsBatch No.Cal.Std.No.Make/GradeUse Before
Fructose
  • Procedure for Polarimeter Calibration:
  • Fructose Solution Preparation:
  • Take the required quantity of ____________________________ fructose and  dry it in a vacuum oven at ___________ 70ºC for _________ 4 hours. (From ________ to ________ ).
  • 10% w/v Fructose Solution:
  • Weigh accurately _________ 5.000 gm (as accurate as possible) of ___________________ previously dried fructose and transfer it in cleanand dry _________ 50 ml volumetric flask.
  • Dissolve it in 25ml of __________ purified water and dilute up to the volume with _________ purified water.
  • Measurements – Polarimeter Calibration :
  • Condition the fructose solution and the blank solution (diluent) (________________ purified water) at ____________ 20°C±0.5°C.
  • Take the reading of ____________________ purified water (diluent) as a blank and make it to auto zero.
  • Fill the tube with the fructose solution of the specified concentration of fructose.
  • Measure the Specific optical rotation of the solution using 1-dm Polarimeter tube.
  • Take ________ five readings of solution.
  • Reading should meet the acceptance criteria as specified in the observation table.
  • Tabulate the results in the observation table.

Observation Table : Polarimeter Calibration

Sr. No.  Concentration of Sucrose (dried) (in %)  Specific Optical Rotation at 20 °C ± 0.5°CSpecific Optical Rotation, SOR (in %) at 20°C
Lamp _________ MercuryFilter _________ 436 nm
12345Mean SOR (in %)  
110

Note:- The limits shall be as per the COA provided by the manufacturer.

Remarks: The instrument is calibrated & qualified/ Out of calibration & not qualified for use.

Calibration type: Scheduled / Not scheduled (Reason: _________________________)

Calibrated by:Checked by:
Date:Date:

Attachments (if any) :-

Sodium Lamp : By Fructose Solution

  • Calibration Requirements – Polarimeter:
  • Lamp used _________ Sodium (Na)
  • Filter (wavelength set) used ______________ 589 nm
  • Analytical Balance Code No.______________ Valid upto _________
  • Vacuum Oven Code No.______________ Valid upto _________
ChemicalsBatch No.Cal.Std.No.Make/GradeUse Before
Fructose
  • Procedure for Polarimeter Calibration:
  • Fructose Solution Preparation:
  • Take the required quantity of ____________________________ fructose and dry it in a vacuum oven at ___________ 70ºC for _________ 4 hours. (From ________ to ________ ).
  • 10% w/v Fructose Solution:
  • Weigh accurately _________ 5.000 gm (as accurate as possible) of ___________________ previously dried fructose and transfer it in cleanand dry _________ 50 ml volumetric flask.
  • Dissolve it in 25ml of __________ purified water and dilute up to the volume with _________ purified water.
  • Measurement – Polarimeter Calibration:
  • Condition the fructose solution and the blank solution (diluent) (________________ purified water) at ____________ 25°C±0.5°C.
  • Take the reading of ____________________ purified water (diluent) as a blank and make it to auto zero.
  • Fill the tube with the sample solution of the specified concentration of fructose.
  • Measure the Specific optical rotation of the solution using 1-dm Polarimeter tube.
  • Take ________ five readings of solution.
  • Reading should meet the acceptance criteria as specified in the observation table
  • Tabulate the results in the observation table.
Sr. No.  Concentration of Sucrose (dried) (in %)  Specific Optical Rotation at 25°C ± 0.5°CSpecific Optical Rotation, SOR (in %) at 25°C  
Lamp ____________                    SodiumFilter _________                 589 nm
12345Mean SOR (in %)  
110   

Note :- The limits shall be as per the COA provided by the manufacturer.

Remarks: The instrument is calibrated & qualified/ Out of calibration & not qualified for use.

Calibration type: Scheduled / Not scheduled (Reason: _________________________)

Calibrated by:Checked by:
Date:Date:

References

  • Operation manual supplied by the manufacturer
  • Maintenance of laboratory instrument/equipment
  • SOP for Instrument/Equipment usage log book.
  • SOP for Preparation of Internal and External (Third-party) calibration schedule and calibration practices
  • Indian Pharmacopoeia Chapter-2.4.22
  • Annexures:
  • Annexure – 1: Format for Polarimeter calibration template ( by Quartz  plate )
  • Annexure – 2: Format for Polarimeter calibration template
Admin Production, SOP

SOP on Procedure for the Operation of Fluidized Bed Dryer (FBD)

OBJECTIVE  :

The purpose of this SOP to describe the procedure for the operation of fluidized bed dryer (FBD).

SCOPE  :

This SOP is applicable for operation of fluidized bed dryer located in the tablet production department at Manufacturing site..

Equipment Name               :  Fluidized Bed Dryer.

Equipment ID No.               :

Manufactured by                 :

RESPONSIBILITY :

Production Officer/ Executive shall be responsible to supervise the operation of fluidized bed dryer.

IPQA Officer/ Executive shall be responsible for verifying the operation of fluidised bed dryer.

Head Production shall be responsible to check the procedure is followed as per SOP.

REFERENCES :

Nil

ABBREVIATIONS:

SOP        :   Standard operating procedure.

IPQA       :   In Process Quality Assurance.

FBD        :    Fluidized Bed Dryer.

I.D. No.  :     Identification Number 

DEFINITIONS :

Nil

GENERAL INSTRUCTIONS :

Check the cleanliness of fluidized bed dryer, its part and area.

Check the ‘CLEANED’ status label available on fluidized bed dryer.

Check the integrity of FBD bowl sieve and inspect the intactness of finger bag.

Check the proper fixing of finger bags, retarding chamber and bowl.

These FBD bags should be stored in separate bins and should be properly labeled.

Use dedicated FBD bag for each product and then check the proper fitting of FBD bag.

Check the steam filter before applying.

After charging powder in FBD bowl push the trolley in the dryer.

Check whether the earthling provided on the dryer are touching the FBD trolley.

Steam indicator valve to be checked during operation.

PROCEDURE :

Operation of Fluidized Bed Dryer:

Before starting the operation production officer / executive shall affix the activity status label having the details such as product name, B.No. Stage etc. to equipment and area and inform to IPQA officer / executive for line clearance.

Adjust the FBD bowl under the retarding chamber.

Switch ‘ON’ the mains.  Open the compressed air valve to apply pneumatic pressure 2.5 kg to 3.5 kg to lock the bowl.

While starting steam drying, Keep steam valve and by pass valve open initially to              drain the condensed water passing through the pipe. Close the condensed valve and adjust the steam valve so as to get the required air inlet temperature. Adjust the timer as per batch manufacturing record. 

Ensure that there is no leakage of air from FBD bowl and outlet.

Remove the container after shaking and rack the material. Again reset the product container and run for further drying. Take out the granules intermittently from the sampling points as and when required for checking the loss on drying.

After completion of operation shut ‘OFF’ the steam valve and air dry the material till the granules attains ambient temperature.

Shake the FBD bag and allow the material to settle down.

Release the compressed air pressure to unlock the FBD bowl from the retarding chamber. 

Remove the product container or go for the further process.

Affix “To be Cleaned “label to equipment .

Record the operation activity in equipment log sheet as per annexure – I.

Inspection of FBD bag shall be carried out for its integrity as per below given points

  1. Check bag for any small holes and torn.
  2. Check the finger of bag for stitches are intact.
  3. Check the corners of bag for intactness and stitches of corners .

Inspection of FBD bag shall be carried out for its integrity before and after the usage and record it in FBD bag usage record as per annexure –II.

After completion of operation clean the equipment as per cleaning procedure.

ANNEXURES:

Annexure – I   :  Equipment Log Sheet.

Annexure – II  :  FBD Bag Usage Record.

Admin Quality Control, SOP

SOP for Qualification of Quality Control analyst

   Objective

To provide detail procedure for Analyst qualification of Quality control analyst for the performance verification.    

  • SCOPE:

            This SOP is applicable for qualification of Quality Control analyst working in QC laboratory at manufacturing facility.    

  • RESPONSIBILITY:

            Manager – Quality Control and Head of Quality assurance is responsible for the qualification of Quality control analyst.

  • PROCEDURE:
    • All new joined analysts in the QC shall be qualified on the basis of accuracy, precision and GLP.
    • Head-QC shall decide nature of work and job responsibility of new recruit. Same shall be authorized by Head-QA.
    • Analyst shall be trained on all specific instruments, equipments, procedures, system and documentation as per requirement of the department.
    • Analysts shall be qualified for critical tests involving instruments eg. HPLC, UV-VISIBLE SPECTROPHOTOMETER, AUOTOTITRATOR, DISSOLUTION TESTER etc…
    • Existing experienced analysts shall be qualified every three years on critical tests & in case of change of job / instruments.
    • The Manager QC shall provide a coded sample (previously analyzed) to the analyst for analysis. Record of coding of samples shall be available with Manager QC (Refer Annexure – II)
  • The sample shall be coded as AQ-YY-001

Where “AQ” is Analyst Qualification

Third Character is “-” dash.

Fourth & Fifth characters “YY” is year

Sixth Character is “-” dash

Seventh character “001” is serial number

For example AQ-20-001

  • The identified sample shall be given to analyst along with details of procedure.
    • The analyst shall also be evaluated for compliance to GLP while working in QC
    • UV, AUTO TITRATOR and HPLC shall be performed in triplicate for assay test & % RSD shall be evaluated.
    • Dissolution Test shall be performed single and compare the results.
    • The test results shall meet the acceptance criteria as per the respective product specification.
    • The analyst shall follow the STP’s of the respective products and do all the documents as per current practices.
    • The raw data shall be finally reviewed by Head-QC and approved by Head- QA.
    • Analyst qualification card of each analyst shall be maintained by respective analyst or by department representative. (Refer Annexure – III).
    • In case analyst not meeting the acceptance criteria, the Manager QC shall look in to record and provide the on job training to the analyst. After the training, analyst shall be re-qualified as per procedure.
    • The analyst validation shall be performed for the critical tests defined in the table below.
  Test Acceptance Criteria
Assay (By HPLC/UV/ Potentiometry/Titrimetry) RSD shall NMT 2.0%
Karl Fisher RSD NMT 2.0% for moisture content more than 5.0% RSD NMT 5.0% for moisture content more than 3.0% to 5.0% RSD NMT 10.0% for moisture content more than 1.0% to 3.0% RSD NMT 15.0% for moisture content up to 1.0%
Dissolution Results shall meet the product specification
  • All analyst shall be issued with certificate based on their job responsibility followed with qualification after successful evaluation as per Annexure – IV.
    • Competency analytical List shall be prepared for each analyst as per annexure V.
    • Requalification:

            Every analyst shall be requalified periodically after every 2 years or as per requirment.

  • TRAINING:

            As per SOP

  • DISTRIBUTION:

As per SOP

  • ANNEXURE:

Annexure I      : Analyst Qualification Record

Annexure II    : Identification for coded sample

Annexure III   : Analyst qualification card

Annexure IV   : Analyst Qualification Certificate.

Annexure V   : Analytical Techniques Competency List.

  • REFERENCES:

Nil

Admin Quality Assurance, SOP

SOP on Cleaning Validation

OBJECTIVE  :

The objectives of good manufacturing practices (GMP) include the prevention of possible contamination and cross-contamination of pharmaceutical starting materials and products.

SCOPE  :

These SOP describe the general aspects of cleaning validation, Normally cleaning validation would be applicable for critical cleaning such as cleaning between manufacturing of one product and another, surfaces that come into contact with products, drug products and API at Manufacturing site.

RESPONSIBILITY :

Production Officer / Executive shall be responsible for monitoring cleaning of equipments

QA Officer / Executive shall be responsible for preparation of validation protocol and report.

IPQA Officer shall be responsible for sampling from cleaned equipment as per protocol.

QC Officer shall be responsible for analysis of samples.

Head Productionshall be responsible for checking validation protocol and report.

HeadQuality Controlshall be responsible for checking validation protocol and report.

Head QA shall be responsible for approval of validation protocol and validation report.

Head-QA shall be responsible for the compliance of the SOP.

REFERNCES:

Health Products and Food Branch Inspectorate ,Guidance Document Cleaning Validation Guidelines GUIDE-0028

World Health Organization ,WHO Technical Report Series, No. 937, 2006

Annex 4 Supplementary guidelines on good manufacturing practices: validation Appendix 3

EU Guideline & VICH Guideline

ABBREVIATIONS :

SOP: Standard Operating Procedure.

QA   :   Quality Assurance.

QC   :   Quality Control.

SS    :  Stainless Steel.

WHO :World Health organization

GMP: Good Manufacturing Practices

API : Active Pharmaceutical Ingredients

ppm :  Parts Per Million.

MACO: Maximum Allowable Carry over.

IPQA: In process Quality Assurance.

DEFINITIONS:

Cleaning Validation: Cleaning validation is a documented evidence to verify that the procedures used to clean the product residue from equipment and components will consistently & significantly reduce the amount of active ingredient, Excipients and cleaning agent to a concentration within calculated acceptance criteria.

GENERAL INSTRUCTIONS: NA

PROCEDURE :

Cleaning validation protocols and reports

Cleaning validation protocol

Cleaning validation should be described in cleaning validation protocol, which should be formally approved.

In preparing the cleaning validation protocol, the following should be considered

     disassembly of system;

— pre cleaning;

— cleaning agent, concentration, solution volume, water quality;

— time and temperature;

— flow rate, pressure and rinsing;

— complexity and design of the equipment;

— training of operators; and

— size of the system.

The cleaning validation protocol should include:

The objectives of the validation process

The Scope of the validation process

The Purpose of the validation process

The people responsible for performing and approving the validation study

The Identification of most sensitive product for contamination on the basis of  

maximum daily dose & minimum batch size

Matrix worst case approach table – based on risk analysis

Acceptance Criteria

List of equipment with internal surface area of each equipment in sq.cm

Identification of difficult to clean surface of equipment (table & drawing facility) The sampling method used as per product specific requirement

Critical areas, i.e. those hardest to clean, should be identified, particularly in large systems that employ semi-automatic or fully automatic clean-in-place systems. The sampling medium and solvent used should be appropriate to the task.

Swab study shall be performing by following manner

Indirect sampling (Rinse method)

Note: This method allows sampling of a large surface, of areas that are inaccessible or that cannot be routinely disassembled and provides an overall picture. Rinse samples may give sufficient evidence of adequate cleaning where accessibility of equipment parts can preclude direct surface sampling, and may be useful for checking for residues of cleaning agents,

Rinse samples should be used in combination with other sampling methods such as surface sampling.

There should be evidence that samples are accurately recovered. For example, a recovery of > 80% is considered good, > 50% reasonable and < 50% questionable

Analytical methods Validation

The analytical methods should be validated before the cleaning validation is performed. The methods chosen should detect residuals or contaminants specific   for the substance(s) being assayed at an appropriate level of cleanliness (sensitivity).

Validation of the analytical method should include as appropriate:

— precision, linearity and selectivity

— limit of detection (LOD);

— limit of quantization (LOQ);

— recovery, by spiking with the analyze

— Reproducibility.

The detection limit for each analytical method should be sufficiently sensitive to detect the established acceptable level of the residue or contaminants

Suitable methods that are sensitive and specific should be used where possible and may include ultraviolet (UV) spectroscopy ,Other methods may include (alone or in combination) measurement of total organic carbon (TOC), pH, or conductivity; and  Enzyme-linked immunosorbent assay (ELISA

Establishing acceptable limits

Note: uniform distribution of contaminants is not guaranteed.

The acceptance criteria established for contaminant levels in the sample should be practical, achievable and verifiable. The rationale for the residue limits established should be logical, and based on the knowledge of the materials involved

Each situation should be assessed individually. The manner in which limits are established should be carefully considered. In establishing residual limits it may not be adequate to focus only on the principal reactant, because other chemical variations may be more difficult to remove. Where necessary, screening using thin-layer chromatography should be performed in addition to chemical analyses.

There should be no residue from the previous product, from reaction by-products and degradants, or from the cleaning process itself (e.g.  Solvents).

The limit-setting be  product-specific

Group products into families and choose a worst case product group products into groups according to risk, e.g. very soluble products, products with similar potency, highly toxic, or difficult to detect products;

Use different safety factors for different dosage forms based on physiological response (this method is essential for potent materials).

Limits may be expressed as a concentration in a subsequent product (ppm), limit per surface area (mcg/cm2), or in rinse water as ppm.

The sensitivity of the analytical methods should be defined to enable reasonable limits to be set

The rationale for selecting limits for carry-over of product residues should meet defined criteria. The three most commonly used criteria are:

Visually clean. (No residue should be visible on equipment after cleaning.) Spiking studies should determine the concentration at which most active ingredients are visible. this criterion may not be suitable for high potency, low-dosage drugs

Not more than 10 ppm of one product will appear in another product (basis for heavy metals in starting materials); and not more than 0.1% of the normal therapeutic dose of one product will appear in the maximum daily dose of a subsequent product.

The most stringent of three options should be used.

Revalidation:

Revalidation shall be carried out in following situations:

a) Equipment change

b) Cleaning equipment change

c) Change in cleaning agent

d) Change in cleaning procedure

e) During new product introduction

f) Once in three years

Procedure for cleaning validation based on worst case products :

Worst case products on basis of solubility :

Hard  to clean product will cover all the easier to clean product also i.e. based on the solubility of products being manufactured, product having least solubility in water can be considered as worst case product.

Worst case product on basis Toxicity data:

Molecule having least LD50 value shall be taken into consideration for cleaning validation

Worst case product on basis of strength:

If the product is manufactured in different strengths, cleaning procedure shall be validated for the highest strength of that particular drug product. If the product contains multi active ingredients, the active ingredient which is less soluble/more in concentration and/or more toxic shall be taken into consideration for cleaning validation.

Worst case on the basis of batch size of next product :

Based on the minimum batch size and maximum surface area of common equipment, product having minimum batch size and maximum surface area can be considered as worst case product.

Justification:

i) As the batch size of next product comes in the numerator of the formula while calculating acceptance criteria. The product which has minimum batch size should be considered as worst case product, which makes the acceptance criteria more stringent.

ii) As surface area common for both the products is in the denominator of the formula while calculating acceptance criteria. The products which involve maximum no. of equipment should be considered as worst case product which makes the acceptance criteria more stringent.

Worst case based on Maximum daily dose of the product :

The principle for the requirement is that the standard Therapeutic Daily Dose (TDD) of the next product may be contaminated by no more than a certain proportion (1/1000 part i.e. NMT 0.001 dose) of the TDD of the product investigated in the cleaning validation (“worst product”). This method only applies when the therapeutic daily dose is known. Scientific rationale for above statement is that pharmaceuticals are often considered to be non active at 0.1 of their normally prescribed dosage (1/10th) and the facility is solid dosage manufacturing unit.

Worst case on the basis of equipment :

If there are different sizes of the same equipment with same cleaning procedures, cleaning validation for the largest size of that particular equipment is adequate. If there are multiple of a particular equipment with same configuration, material of construction and cleaning procedure, then cleaning validation of one piece of that particular equipment will be adequate

Worst case on basis of 10 PPM criteria:

NMT 10 ppm of previous product shall appear in next product. 10 PPM criteria shall be followed until the identification of the worst case product. Scientific rationale of above statement is based on regulations for food industry which provides for maximum permissible limit of certain levels of hazardous substances.

Waste case on basis of Health Based Data:

The Maximum Allowable Carryover (MACO) should be based upon Permitted Daily Exposure (PDE). In the health based data criteria, the principle of MACO calculation is based on acceptable carry-over of previous product, based upon the PDE, into next product. The molecules having least PDE value shall be taken into consideration for cleaning validation..

Swab Recovery Study and Coupon Recovery Study should be performed.

Record the products which are considered as worst case on the solubility, maximum strength. Therapeutic potency under present product and product which are considered as worst case product based on batch size in Kg and maximum daily dose under product to be considered as next product for calculating acceptance criteria.

Based on the new product introduction and conclusions.

Periodically review the data with respect to new products and new equipment being used for production at the site and observations should be recorded.

This should done to keep a track whether the worst case products is still justified. Based on the above review with respect to new products and new equipment, determine whether validation needs to be carried out or not. A new validation report should be filled in case of change in the worst case product.

Based on the information about batch size, number of dosage units per batch, uncommon equipment, smallest strength manufactured, maximum daily dosage, product contact surface area, solubility of active ingredient in water, chain of equipments used during manufacturing the worst case product can be decided.

ANNEXURE(S):

Annexure – I  : Flow Chart of Cleaning Validation Procedure

Annexure – II : Surface Area Sheet

Annexure –III : Sampling Points

Annexure –IV :Cleaning Validation Protocol

Annexure –V : Cleaning Validation Report

Admin SOP

SOP on Analytical Report (AR) Numbering

OBJECTIVE:

The purpose of this SOP to lay down the procedure for Analytical Report (AR) numbering.

SCOPE:

This SOP is applicable for the procedure for Analytical Report (AR) numbering in Quality Control Department at manufacturing facility.

RESPONSIBILITY:

Analyst / Section Head or his designee shall be responsible for follow the SOP.

The Head of Quality Department or his designee shall be responsible and implementation of the SOP.

PROCEDURE:

In-process materials:

For all in-process and intermediate products of bulk are entered date wise and serial number wise in the finished product register.

Raw materials:

AR numbering is COMPANY NAME/RM/YY/ABCD

Where,

COMPANY NAME   :          

RM                              :           Raw material

YY                              :           Year

ABCD                         :           Serial number

Packing materials:

            AR numbering is COMPANY NAME/PM /YY/ABCD

            Where,

            COMPANY NAME   :          

            PM                              :           Packing material

            YY                              :           Year

            ABCD                         :           Serial number

Finished product:

Tablets:

            AR numbering is COMPANY NAME/TA/YYABCD                        

            Where,

            COMPANY NAME      :       

            TA                                  :        Tablets

            YYABCD                      :        Year & Serial Number

Pellets :

            AR numbering is COMPANY NAME/PE/YYABCD

            Where,

            COMPANY NAME     :        

PE                                 :         Pellets

YYABCD                   :           Year & Serial Number

Hard Gelatin Capsules :

AR numbering is COMPANY NAME/HC/YYABCD

Where,

COMPANY NAME     :        

HC                                :         Hard Gelatin Capsules

YYABCD                     :         Year & Serial Number

Water analysis:

AR numbering is COMPANY NAME/PW/BW/RW-DD/MM/YYABCD

Where,

COMPANY NAME               :          

PW/BW/RW                           :           Purified water and Potable water / Bore water / Raw                                                            water

DD                                          :           Date

MM                                         :           Month

YY                                          :           Year

ABCD                                     :          Serial No.

Rinse-Swab Cleaning Sample:

AR numbering is COMPANY NAME/SW/YY/ABCD

Where,

COMPANY NAME   :          

SW                              :           Rinse/Swab Cleaning sample

YY                              :           Year

ABCD                         :           Serial number

Miscellaneous:

            AR numbering is COMPANY NAME/MS /YY/ABCD

            Where,

            COMPANY NAME   :          

            MS                              :           Miscellaneous item

            YY                              :           Year

            ABCD                         :           Serial number

TRAINING:

As per Training SOP

           DISTRIBUTION:

             As per SOP Documentation  Control

  ANNEXURE:

Annexure – I      : A.R Number register of Pellets

Annexure – II    : A.R. Number register of Rinse/Swab Cleaning sample

Annexure – III   : A.R. Number register of Miscellaneous items

Admin Quality Control, SOP

SOP ON Receipt, Issue & Control Of Lab Chemicals

SOP ON Receipt, Issue & Control Of Lab Chemicals

  • OBJECTIVE:

The purpose of this SOP is to lay down a procedure for issue, control and disposal of lab chemicals.

  •       SCOPE:

This SOP is applicable for issue, control and disposal of lab chemicals in Quality Control Department at manufacturing site. 

  •       RESPONSIBILITY:
    • Analyst / Section Head or his designee shall be responsible for follow the SOP.
    • The Head of Quality Control Department or his designee shall be responsible and implementation of the SOP.
  •       PROCEDURE:
    • Lab chemicals shall be received and checked at the gate office by security staff and stamped as “MATERIAL IN” with date and signature.
    • The responsible chemist shall check the name, quantity, and grade & pack condition. The damaged or opened pack shall be returned to the respective vendor.
    • The chemist shall label the container as per the format given in Annexure–I.
    • The chemical shall be arranged alphabetically in the chemical rack taking into account the incompatibility characteristics. The acid chemical shall be stored in plastic tray filled with sand.  The chemicals shall be stored in chemicals storage room.
    • The inflammable solvents shall be stored separately.
    • The hygroscopic chemicals shall be stored separately.
    • Inward register as per the format given in Annexure-II.

Shelf life of the chemicals is given below:

Hygroscopic and Deliquescence materials : Six month from the Date of openings of chemical.
For all solvents, : Two year from the Date of issue of chemical.
Chemicals other than as mentioned Above. : Two Years from the opening of chemical bottle.
  •   The empty pack shall be returned for disposal and documented.
  •     TRAINING:

as per SOP on Training of Employees

  •     DISTRIBUTION:

as per SOP on SOP

  •     ANNEXURE:

              Annexure –I  : Label for lab chemicals

              Annexure –II : Lab chemical Inward Register

  •     REFERENCES(S):

    Nil

Admin Quality Control, SOP

SOP On Safety In Quality Control Laboratory

SOP On Safety In Quality Control Laboratory

  • OBJECTIVE:

The purpose of this SOP is to lay down a procedure for describe safety aspects and precautions during working in the department.

  • SCOPE:

This SOP on Safety in Quality Control Laboratory is applicable for guidelines regarding safety hazards occurring during laboratory working and to guide on safe handling of various reactions during analysis, and handling some of corrosive and poisons like Potassium Bromide in Quality Control Department at manufacturing site.

  • RESPONSIBILITY:
    • Analyst or his designee shall be responsible for follow the SOP.
    • The Head of Quality Control Department or his designee shall be responsible and implementation of the SOP.

PROCEDURE:

  • BASIC SAFETY PRACTICES – SOP on Safety in Quality Control Laboratory
  • Keep the work area clean before and after each activity/analysis.                    
  • Deposit garbage, wastes etc. in the appropriate dustbins meant for them. Keep the floors dry by mopping up any spillage soon after it occurs.
  • Keep all gangways, emergency exits and staircases free from obstructions. Make sure that all fire-fighting equipment is readily accessible.
  • Collect broken glass pieces with a broom and dustpan. Broken pieces of glass must be picked up from the floor by using a wet cloth and ‘never with bare hands’. All broken glassware should be collected in a separate dustbin. At the end of the week or as and when required, all broken glassware should be disposed in the scrap yard.
  • Do not eat, drink or smoke in the laboratory.  Do not store food in the work areas and do not keep food or drinking water in refrigerators that are used to store chemicals, reagents and biological materials. Do not drink water kept in laboratory wash bottles.
  • Wash the hands thoroughly with soap and water or where necessary with cleaning agents, after leaving the work area.
  • Wear suitable protective gear such as helmets, safety goggles, face shield, safety foot wear, gloves (acid proof, alkali proof and Kevlar) etc., while doing hazardous jobs and during sampling in the Stores area.
  • Always use a rubber bulb or pump to withdraw solutions. Use a dispenser to withdraw corrosive liquids like strong acids or alkalis.
  • When boiling a solution in a test tube keep the mouth of the test tube away from the co-worker next to you and away from yourself.
  • Handle hot glassware carefully e.g. distillation assembly, articles removed from muffle furnace, driers etc.  (Hot glass looks exactly the same as cold glass). Always wear Kevlar hand gloves while handling hot glassware.
  • Never carry out unauthorized experiments and never taste, smell or inhale any chemicals in the laboratory.
  • An open flame may be ignited only when no flammable solvents are in the vicinity.

  • BENCH OPERATIONS – SOP on Safety in Quality Control Laboratory
    • Do not start an experiment on a bench already crowded with apparatus or equipment. Clear the workbench of unwanted chemicals and reagents.
    • Before starting a test, familiarize yourself with the known hazards of the material (Refer Material Safety Data Sheet) and the operations to be performed and equip yourself with the necessary protective gear and devices.
    • Ensure that all reagent bottles, containers and other glassware in use are correctly and clearly labeled.
    • Pour liquids in a direction away from the label to avoid damaging the label. If any liquid spills over the sides of the container, wash or wipe the surface with water before returning it to the shelf.
    • Examine all glassware for damage before use. Do not use cracked, chipped or any other defective glassware.
    • Support all large glass flasks adequately. Additional support at the base improves stability.
    • Use lubricant and a cloth for protection when inserting glass tubing rods and thermometers into bungs or tubing. While cutting a glass tube or rod, use gloves and safety goggles.
    • To remove tight glass stoppers, tap alternately on each side of the stopper or sonicate. If this does not work and the contents of the bottle are not flammable or toxic, gently warm the neck of the bottle.
    • Carry out tests involving hazardous and fume-generating chemicals only in a fume hood with   proper exhaust systems.

  • SOLVENT EXTRACTION – SOP on Safety in Quality Control Laboratory
  • When using a separating funnel for solutions containing solvents release the pressure developed on shaking by inverting the funnel with the stopper securely held and opening the tap with care.  Point the funnel away from the eyes and any source of heat such as a naked flame or heating mantle.Ensure that the condensing system above a Sox let extraction unit is adequate to cope with the solvent in use.Removal of solvents in an experiment involving flammable solvents should be carried out using a water-bath or electrically heated bath.For low-boiling liquids such as liquor ammonia, ether etc., cool the container before opening, using protective equipment such as gloves and safety goggles.
  • HANDLING OF GAS CYLINDERS       
  • Store cylinders in a well-ventilated place in an area where no flammable substances are stored.
  • Protect cylinders from direct sunrays and avoid storage on wet ground.
  • Never drag or roll a compressed gas cylinder. Use a handcart to transport cylinders.
  • Use cylinders in an upright position. Always secure and chain them to prevent accidental knocking over.
  • Always use a pressure-reducing regulator free from oil and grease, attached to the cylinder valve.  Keep the metal cap in place to protect the cylinder valve.  Before removing a regulator from the valve, close the valve and release the gas from the regulator.
  • Do not use an oxygen cylinder with oily hands or oily gloves as even a small amount of oil or grease may ignite violently in the presence of oxygen released under pressure.
    • HAZARDOUS CHEMICALS
  • Wear safety goggles, and nose masks where considered necessary. Use a face shield and protective gloves while handling hazardous chemicals.
  • Transport containers of capacity of one liter or more in stainless steel carriers and containers of capacity five liters or more on a trolley and do not carry the chemicals in open containers.
    • FLAMMABLE LIQUIDS
  • Store bare minimum stock of solvents in the laboratory. Store liquids that are not in use preferably in a suitable fire resistant cupboard or bin, made of steel or wood. The cupboard must be robust, properly labeled and not used for any other materials.          
  • Return the solvent bottles to the storage area after use.
  • Do not store flammable solvents in the refrigerator as the electrical control and switches in the refrigerator may cause sparks, which could be a source of ignition for flammable vapors. Do not store flammable liquids near oxidizing agents such as chromic acid, permanganates, chlorate and per chlorates.
  • Isolate experiments which require large amounts of flammable solvents and ensure that adequate fire-extinguishers are available. Use a water-bath or electric heating mantle when large amounts of flammable solvents are to be heated. Do not pour out solvents near a naked flame.
  • If any spillage of flammable solvents occurs, use a suitable absorbent to absorb the liquid and dispose off the contaminated absorbent by incineration in a pit.
  • Do not pour water-immiscible solvents down the drains.
  • Never mix miscible and immiscible waste solvents in a common bottle or carboy.
    • CORROSIVE CHEMICALS
  • While handling corrosive chemicals, use safety apparel such as nose masks, rubber gloves, safety goggles, rubber aprons etc. Avoid contact of the chemical with body surfaces, including the alimentary and respiratory system.
  • Do not store large bottles of acids and other corrosive materials above waist level.
  • Do not leave apparatus containing corrosive materials at the sink, to be washed; always drain out the contents and rinse the apparatus with tap water before leaving it for washing.
    • HANDLING OF POISONOUS CHEMICALS    
  • Handle poisonous chemicals with abundant caution.  Ensure that the containers are well sealed after use and only then placed in the cupboard.
  • Carry out the work involving poisons in the fume hood only and do not inhale poison fumes. Wear gloves if large volumes are to be handled.
  • After working with poisonous chemicals wash the work place and contaminated glassware with dilute alkali solutions followed by water.
  • Keep antidotes for each poisonous chemical (up to the extent possible) in the laboratory.
  • Wash any contacted skin area with soap and water at once.
    • ELECTRICAL HAZARDS
  • See that all wires are properly insulated and instruments well earth.
  • Ensure that no water points or rubber connections carrying water are allowed to leak on to electrical plugs and switches.
  • Ensure that worn or damaged cables, sockets and plugs are replaced promptly.
    • BACTERIAL HAZARDS
  • Place contaminated glassware in a chemical disinfectant immediately after use and before cleaning and reusing.
  • Decontaminated waste, including specimens of bacteria, by effective means prior to disposal as refuse or seal in sturdy, impervious containers for incineration.
  • Sterilize culture plates and tubes adequately before washing or discarding them.
  • Clean bench tops, incubators, furniture and floors that may be contaminated, at least weekly with an effective disinfectant.
  • Clean and disinfect any spillage immediately.
    • FIRE SAFETY
  • Ensure proper use, storage and disposal of flammable and combustible liquids/ solids used in the laboratory.
  • Equipment and instruments to be inspected periodically for electrical wiring, earthing and general cleanliness.
  • Check regularly all fire-fighting equipment and ensure that they are in operating condition.  Ensure that a sufficient number of people are trained in the use of the equipment.
  • If any fire is small immediately control it with a fire extinguisher. If it is of a more serious nature, raise the alarm and follow the factory drill for fighting fires.
  • Use carbon dioxide or any other suitable fire extinguishers for instruments.
  • Identify the safety squad and train them.
    • EMERGENCIES
  • In case of an emergency know the location and operation of

            i.    Fire extinguishers

            ii.   Safety air shower, Eye washer

            iii.  Fire alarm

  1. Telephones
  2. Ensure that there is a first-aid kit in the laboratory and that it is adequately stocked with the basic supplies of first- aid materials.
  3. In an emergency follow the laid down factory procedure and have first aid rendered by people trained in first-aid techniques.
  4. Keep the emergency exit free of obstructions.
  5. Do not use lift for evacuation during an emergency. Use the staircase.
    1. ACCIDENTS
  6. Treat minor injuries by rendering first aid and then send the victim to a medical center for further treatment.
  7. For major injuries arrange for immediate medical aid.  Do not move the person except to a position of less danger. Keep the person warm and quiet to minimize the effects of shock.
  8. In the event of poisoning immediately give large amounts of water to dilute the poison and call for a doctor.  In the case of gas poisoning transfer the victim into fresh air surroundings immediately and if breathing has stopped give artificial respiration. If person is unconscious, do not give anything from mouth.
  9. In case of electric shocks switch off the main switch and push the victim away from the electric wires with a dry non-conducting material, by standing on a dry board or a rubber mat. Do not touch the victim until contact with the source of current is broken.
  10. Treat eye injuries by flushing with water immediately for about 15 minutes and rush the victim to a doctor for treatment.
  • TRAINING:

Trainer             : Head – Quality Control

Trainees           : Quality Control chemist / Sectional Heads

  • DISTRIBUTION:

As per SOP Format SOP

  • ANNEXURE:

Nil

  • REFERENCES(S) :

Nil