STANDARD OPERATING PROCEDURE FOR SWAB AND RINSE SAMPLING AND ANALYSIS FOR CLEANING VALIDATION

1.0                      OBJECTIVE

1.1                   To provide a procedure for swab and rinse sampling during validation of equipment and accessories and analysis of the same.

2.0                      SCOPE

2.1                   This procedure applies to Quality Control Laboratory

           

3.0                      RESPONSIBILITY

3.1                          IPQA person responsible for sampling of rinse and swab samples.

3.2                          Production- Department responsible for the sending the intimation for sampling of rinse and swab sample.

3.3                          Analyst-Quality control responsible for analysis of rinse and swab samples.

                                   

3.4                   Head-Quality Control or designee responsible for compliance of the SOP.

4.0                          PROCEDURE

4.1                   GENERAL PREPARATORY WORK:

4.1.1                When the intimation obtained from QA for the sampling of rinse and swab analyst shall make a necessary arrangement for sampling i.e. required number of volumetric flasks, bottles with screw cap, test tubes, solvent and hand over to QA person

                       

4.1.2                      Take swab stick for sampling.

4.2                   Procedure for swab sampling:

4.2.1                Depending on the product, moisten the swab (membrane filter) with appropriate solvent. Use hand gloves, nose mask and snood whenever required.

4.2.2                  Immediately after wetting the membrane filter, swab the specific equipment surface as    per the sampling plan.

4.2.3                  The surface area to be swabbed is 5 x 5 cm². If the surface area is less than 5 x 5 cm²,    calculate available area and perform the activity.

4.2.4                  Swab sample will be taken after final rinse from equipment surface, which are hard to      clean.

4.2.5                Swab the plates as per the direction given below and prepare the test solution as per                             test method.

 

                                                                       

                                                                                   

                       

4.2.6                  Transfer the swab into the 10 ml volumetric flask and analyze as per the validated            analytical method.

                        Note: For swab use nylon swab (texwipe part number Tx714A ) of 0.45 µm and 25 mm in diameter.

4.3                   Procedure For Rinse Sampling:

4.3.1                Clean the equipment as per the respective cleaning procedure.

4.3.2                                       Collect the rinse at predetermined time intervals as specified in individual sampling plan.

4.4                    Procedure For Rinse and Swab Analysis:

4.4.1                  Analyse the rinse and swab samples as per the individual procedure.

4.4.2                                Apply recovery factor (obtained from validation study of respective product) for calculating the content if the same is found less than100%. If recovery is observed more than 100%, do not apply factor for calculation.

E.g. if the % recovery of the method is 99.0% and result obtained is 2.0 ppm, then apply recovery factor as follows: 

                                    Observed result x 100

                                 Content (ppm) = ----------------------------

                                                                        % Recovery       

                                                                   2.0 x 100

                                 Content (ppm) = -------------------- = 2.02 ppm.

                                                                        99.0    

4.4.3                 Cleaning validation and Cleaning verification samples shall be entered in Cleaning

           Validation & Cleaning verification samples inward register, Annexure: 6QC032/A01.