SOP For Operation, Maintenance And Calibration Of Ultrasonic Water Bath

The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for Operation, maintenance and Calibration of Ultrasonic Water Bath.

  • PROCEDURE:
    1. PRELIMINARY CHECK:
      1. Fill the Water bath with water up to height of minimum 7cm from bottom of tank. Whenever the Ultrasonic Water Bath is required with specific temperature then heater to be kept “ON”.
      1. Ensure that there is no leakage of water from water bath.
      1. Do not put any heavy objects on the bottom of the tank as it can damage the transducers. Always use tray supplied with ultrasonic bath.
      1. Ensure that liquid does not splash on the controls and switches.
  • Basic Operation :Connect the Ultrasonic Water Bath to the main power supply with the connecting plug the cleaner into grounded outlet after power on the temperature displays the actual environment temperature time and temperature default as the last setting ones.( 3 minutes default time for initial use temperature display 0°C)Press + Button adjustable for timer working time increase 1 minute hold the key the time raised by 10 minutes continuous in the contrary.Press – Button adjustable for timer working time reduce 1 minute hold the key the reduced by 10 minutes continuous the cleaning stops when the counts down 00:00.Press Button for heating key for temperature setting with the range 0°C-80°C.Press + Button adjustable for heating a time temperature will rise 1°C holding the key temperature will rise continuously with 10°C in the contrary.Press – Button temperature reduce 1°C holding the key temperature reduced continuously with 10°C usually the best results are with 40°C-60°C.When setting the temperature if the setting temperature exceed the environment temperature Press button heating key the heating working and indicator light up below the environment temperature heating can’t start and the indicator light turn off.Heating won’t shut off automatically when the environment temperature below the setting press Button heating key in to stop heating (heating can’t stop if you don’t press Button heating key).After time and temperature setting press Button heating key en press any other keys Degas,Soft, Normal Machine start to work indicator light up if need to stop heating or ultrasonic press corresponding key again then corresponding indicator lights turn off.Machine stop working after 8hours working time (power saving mode) in this made machine restored to the standby state once you press any key.Three ultrasonic working mode:Degas mode: Press Degas Button intermittent operation of ultrasonic power for rapid removal of entrained air from liquids ultrasonic work 6 seconds and stop 2 seconds same cycle to be proceed & press Degas key again to stop it.Normal mode: Press Normal Button to start the normal faction strong ultrasonic power with large current press again to stop it.Soft mode: Press Soft Button to start soft function continuous slight variation of ultrasonic frequency to eliminate hot spots dead zones and standing waves press again to stop it. During working you will hear the “sizzling“ voice that means the cleaner running properly.
  • MAINTENANCE  : Ensure system is off and disconnect the power cable from the main socket before cleaning.Clean the water bath and replace the water on daily basis or as and when the water gets turbid.
  • CALIBRATION PROTOCOL:

            Calibration Frequency: Yearly

  • Carry out the Calibration of temperature indicator controller with sensor and time by an approved external party.

Calibration, Verification of Performance and Qualification of Equipment, Instruments and other devices in Quality Control

Calibration, Verification of Performance and Qualification of Equipment, Instruments and other devices in Quality Control. Each item of equipment, instrument or other device used for testing, verification and/or calibration should, when practicable, be uniquely identified.

All equipment, instruments and other devices (e.g. volumetric glassware and automatic dispensers) requiring calibration should be labelled, coded or otherwise identified to indicate the status of calibration and the date when re-calibration is due.

Laboratory equipment should undergo design qualification, installation qualification, operation qualification and performance qualification (for definitions of these terms see the Glossary) (11). Depending on the function and operation of the instrument, the design qualification of a commercially available standard instrument may be omitted as the installation qualification, operational qualification and performance qualification may be considered to be a sufficient indicator of its suitable design.

As applicable, the performance of equipment should be verified at appropriate intervals according to a plan established by the laboratory.

Measuring equipment should be regularly calibrated according to a plan established by the laboratory (11).

Specific procedures should be established for each type of measuring equipment, taking into account the type of equipment, the extent of use and supplier’s recommendations. For example:

— pH meters are verified with standard certified buffer solutions before use;

— balances are to be checked daily using internal calibration and regularly using suitable test weights, and requalification should be performed annually using certified reference weights.

Only authorized personnel should operate equipment, instruments and devices. Up-to-date SOPs on the use, maintenance, verification, qualification and calibration of equipment, instruments and devices (including any relevant manuals provided by the manufacturer) should be readily available for use by the appropriate laboratory personnel together with a schedule of the dates on which verification and/or calibration is due.

Records should be kept of each item of equipment, instrument or other device used to perform testing, verification and/or calibration. The records should include at least the following:

  1. the identity of the equipment, instrument or other device;
  2. the manufacturer’s name and the equipment model, serial number or other unique identification;
  3. the qualification, verification and/or calibration required;
  4. the current location, where appropriate;
  5. the equipment manufacturer’s instructions, if available, or an indication of their location;
  6. the dates, results and copies of reports, verifications and certificates of all calibrations, adjustments, acceptance criteria and the due date of the next qualification, verification and/or calibration;
  7. the maintenance carried out to date and the maintenance plan; and
  8. a history of any damage, malfunction, modification or repair.

 It is also recommended that records should be kept and additional observations made of the time for which the equipment, instruments or devices were used.

  1. Procedures should include instructions for the safe handling, transport and storage of measuring equipment. On reinstallation, requalification of the equipment is required to ensure that it functions properly.
    1. Maintenance procedures should be established, e.g. regular servicing should be performed by a team of maintenance specialists, whether internal or external, followed by verification of performance.
    2. Equipment, instruments and other devices, either subjected to overloading or mishandling, giving suspect results, shown to be defective or outside specified limits, should be taken out of service and clearly labelled or marked. Wherever possible they should not be used until they have been repaired and requalified.
    3. When the equipment, instruments and other devices are outside the direct control of the laboratory for a certain period or have undergone major repair, the laboratory should requalify the equipment to ensure its suitability for use.

 Note: For further guidance on calibration, verification of performance and qualification of equipment refer to:

  • Procedures for verifying and calibrating refractometers, thermometers used in determinations of melting temperatures and potentiometers for pH determinations and methods for verifying the reliability of scales for ultraviolet and infrared spectrophotometers and spectro-fluorometers in The International Pharmacopoeia (19);
    1. Specific guidelines for qualification of equipment elaborated by the European Network of Official Medicines Control Laboratories (OMCL) (20); and
    2. General chapter of the US Pharmacopeia on Analytical instrument qualification (21).

Traceability

The result of an analysis should be traceable, when appropriate, ultimately to a primary reference substance.

All calibrations or qualification of instruments should be traceable to certified reference materials and to SI units (metrological traceability).