Standard operating procedure rinse and swab sampling of cleaned equipment in the pharmaceutical industry 

Title: Standard operating procedure for rinse and swab sampling

Objective: To describe the procedure for rinse and swab sampling to clean equipment and their surfaces are free from contaminants.

Scope: This sop applies to all the equipment that requires validation and cleanliness monitoring.

Responsibility: 

• QA department is responsible for collection of swab and rinse samples for chemical cleaning verification
• QC department is responsible for analysis and testing and release of results
• Production is responsible for ensuring cleanliness and raising request for swab and rinse .
• Head Quality responsible for overall compliance of SOP.

Procedure:

Preparation for Swab Sampling: 

Ensure all the person involved in swab sampling are trained and make the swabs sticks, test tubes, , solvents and rinse bottle ready for the sampling, most of the time QC will prepare the swabs and rinse bottles

Swab Sampling:

•  Identify the equipment or surface area for swab sampling using cleaning validation protocol and product matrix.
•  Take the already prepared swabs dipped in appropriate solvent and swab the locations mentioned in the protocol.
•  Swab a defined area ( 10 cm x 10 cm for chemical swab ) using a systematic pattern (e.g., vertical and horizontal strokes).
•  Use a fresh swab for each location if multiple areas are sampled.
•  Place the swab after sampling in test tubes provided by QC
•  Label each swab with the location and the equipment details.
•  Send the swab to the QC lab for analysis.

Rinse Sampling: 

•  Identify the equipment for rinse sampling
•  Most of the time for rinse water is used as solvent and rinse equipment surface area with appropriate quantity of water mentioned in the protocol
•  Rinse the equipment by ensuring thorough coverage.
•  Collect the rinse solution in a glass bottle with screw cap, collect approximately 100ml.
•  Label the glass bottle with the appropriate information (e.g., equipment ID, date, and time).
•  Send the sample to the QC lab for analysis.

 Note: After sending the rinse and swab samples to quality control lab, they will analyze the samples es and sends the results, if the results are within the acceptable limits, then the equipment can be used, if not it is assigned recleaning and again request for swab and rinse sampling will be made until the results comply,

• Microbial cleaning verification is done by QC person and the swab area is 5*5
• For swab sampling Teflon templates are used for exact coverage of swab area.
• Document the swab sampling activity in the respective annexure.