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 to 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 Use Test tubes of appropriate size, and labeled it 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 the 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 horizontally and vertically by shifting to the other ends of a swab and moving the swab head unidirectional as per the drawings in the Annexure (given below) 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 the warding record as per Annexure III
4.1.12 After inwarding in the respective records, send the swab water samples to the QC laboratory along with the 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 the Production department to start Process.
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 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 per Annexure III.
4.2.7 After inwarding in the respective records, send the rinse water samples to the 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 the results of rinse water are not complying with the specification, intimate the Production Officer to re-cleaning 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
Annexure II: Sample analysis requisition slip for a swab and rinse water
Annexure III: Swab and rinse water sample inwarding resister