1.0 Purpose: 1.1 To lay down the Standard Operating Procedure for the collection of the swab and rinse water samples
2.0 SCOPE: 2.1 This SOP is applicable for all the cleaned equipment in the Pharmaceutical manufacturing plant.
3.0 RESPONSIBILITY: 3.1 QA Officer is responsible for the Collection of Swab and rinses water samples.
3.2 Head QA is responsible for ensuring overall compliance with this SOP.
4. Procedure for collection of the swab and rinse water samples:
4.1 Swab sampling:
4.1.1 On receipt of the request for sampling from production, ensure the availability of cotton swabs (Sterile cotton swabs in screw-capped Polypropylene tubes).
4.1.2 Use Purified water as a solvent or other organic solvent as mentioned in the cleaning validation protocol.
4.1.3 Sampling frame: For flat surfaces, use a 10 X 10 cm stainless steel frame in the case of uneven surfaces. The sample is to be calculated approximately to the equivalent area.
4.1.4 Test tubes of appropriate size, labeled with swab numbers as per the protocol, to keep swabs after sampling and Teflon plug/shrink-wrap film closing the tube.
4.1.5 During handling, do not allow the swab head to be contaminated by contact with another surface.
4.1.6 Wear powder-free gloves and a nose mask while sampling. Soak the swab in the solvent and hold it until dripping stops.
4.1.7 Identify the sampling location as per the specific cleaning validation protocol. For flat surfaces, keep the sampling frame on the sampling location. In the case of uneven surfaces, The sample is to be calculated approximately to the equivalent area.
4.1.8 Perform swabbing in a controlled fashion by striking the sample using the width of the swab head to cover the sample surface.
4.1.9 Start swabbing from one end of the swab in horizontal and vertical by shifting to other ends of a swab and moving the swab head unidirectional as per the drawings of Annexure and taking care not to touch the sampling frame.
4.1.10 Mention the location of the sample on the swab tube with the help of a glass marker and fill in the details in “Sample analysis requisition slip for a swab and rinse water” as per Annexure-II.
4.1.11 Make an entry in the swab and rinse water sample in warding record as per Annexure III
4.1.12 After inwarding in the respective records, send the swab water samples to QC laboratory along with requisition slip
4.1.13 Officer QC shall analyze the sample as per current specification and standard analytical procedure/protocol and intimate the analysis result to officer QA.
4.1.14 If results comply, intimate Production department to start
4.1.15 If the sample results are not complying with the specification, intimate Production Officer for re-cleaning of the equipment or equipment part.
4.1.16 Again, collect the swab sample and repeat the procedure
following Point 4.1.1 to 4.1.13.
4.2 Rinse water sampling:
4.2.1 After cleaning, the Production Officer shall inform the QA Officer to collect the rinse water sample.
4.2.2 Enter into the respective area and visually observe the machine or part of the machine.
4.2.3 If visually found satisfactory, make production personnel rinse the machine or part of the machine.
4.2.4 Wear powder-free gloves and a nose mask. Flush out rinse water and collect a 100 ml sample in a cleaned screw-capped glass bottle.
4.2.5 Make required entries in the label ‘Sample for Analysis’ as per respective SOP and stick it on the sample bottle.
4.2.6 Make an entry in the “Swab and rinse water sample inwarding resister” as er Annexure III.
4.2.7 After inwarding in the respective records, send the rinse water samples to QC laboratory along with a requisition slip
4.2.8 QC officer shall analyze the sample as per current specification and standard analytical procedure/protocol and intimate the analysis result to officer QA.
4.2.9 If results comply, then intimate the Production department to start the process.
4.2.10 If results of rinse water are not complying with the specification, intimate Production Officer for re-cleaning of the equipment or equipment part.
4.2.11 Again, collect a sample of rinse sample and repeat the procedure following points 4.2.1 to 4.2.8