The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for sampling of Rinse / Swab during manufacturing of different products.
This SOP is applicable for sampling of Rinse / Swab during manufacturing of different types of products at manufacturing facility.
- Authorized designee of QA shall prepare the SOP & receive the requisition and collect the sample.
- Head QA shall approve the SOP and ensure its proper implementation to avoid contamination during manufacturing of products.
- During manufacturing all rinse and swab sample should be withdrawn by IPQA person.
- For sampling of rinse and swab production persons shall prepare the swab/rinse intimation slip (F/QA042/01) and submit to IPQA officer/designee for sampling.
- IPQA Person shall collect sampling kit & collect the sample according to specified location.
- Rinse sampling: After satisfactory visual inspection, rinse sampling is carried out by using purified water. Rinse sample allow sampling of a large surface area and of inaccessible system or ones that cannot be routinely disassembled. 100 ml rinse sample should be collected from each identified sampling point for analysis.
- Swab Sample: Swab sampling should be collected from pre-determined location swab sample should be collected by using nylon swab in 10 ml of purified water for analysis. wipe the swab sampling surface (25.8064 cm2) continuous in Zig-Zag condition as show in diagram given below.
- OfficerIPQA shall collect the sample from the specified sampling location, Swab sampling should be collected from pre-determined location swab sample should be collected by using nylon swab in 10 ml of purified water for analysis. Wipe the swab sampling surface (25.8064 cm2) continuous in Zig-Zag condition the diagram given below.
- Officer IPQA shall collect swab / rinse sample and submit to quality control / Microbiology department for analysis.
- Officer QC shall receive the slip and analysis the sample and submit the report to IPQA.
- If cleaning sample (Rinse/Swab) fails during QC analysis, investigation (OOS) shall be carried out to find the root cause.
- If in the investigation it has found the cleaning sample (Rinse/Swab) has been failed due to improper cleaning, the equipment shall again re-clean and sample shall be send to QC.
- The equipment shall be release only after the effective evaluation of the re-cleaning.
Trainer : Head – Quality Assurance
Trainees : Departmental / Sectional Heads of production,
Packaging, QC, Microbiology, stores.
Controlled Copy No.1 : Head of Department – Quality Assurance
Controlled Copy No.2 : Head of Department – Production
Controlled Copy No.3 : Head of Department – Quality Control
Controlled Copy No.4 : Head of Department – Microbiology
Controlled Copy No.5 : Head of Department – Warehouse / Stores
Controlled Copy No.6 : Head of Department – Packing
Original Copy : Head – Quality Assurance
Annexure-I : Rinse and Swab Analysis Intimation
- REVISION HISTORY:
|Sr. No.||Revision No.||Change Control Number||Details of Revision||Reasons(s) for Revision|
|1||00||———–||New SOP||New SOP|