Sampling & Testing Procedure For Swab / Rinse Water

 

1.0     OBJECTIVE:

To lay down the procedure for Sampling and Testing for Rinse water and swab samples after cleaning.

2.0     SCOPE:

This SOP is applicable to cleaning of all equipment/accessories used in Production during Product to Product Changeover at -------------------------

3.0     RESPONSIBILITY:

3.1  Concerned department and Production personnel responsibility for the intimation to IPQA/QA personnel for Rinse/Swab sampling after cleaning.

3.2  IPQA responsibility for the Complies of the SOP.

3.3  Quality Control Officer/IPQA responsible for the sampling.

4.0     ACCONTABILITY:

The Accountability for implementation and compliance of the SOP is of Quality Assurance Head.

5.0     PROCEDURE:

5.1  To ensure that the procedure adopted for cleaning shall be effective and able to remove traces of active ingredient of the previous product which may cause cross-contamination from manufacturing equipment to the product. To provide procedure for analysis of Rinse water and swab samples after cleaning of equipments.

5.2  Precaution for Sampling of Rinse /Swab water for analysis:

5.2.1        Before taking Rinse / Swab sample, sample bottle/ test tubes should be clean and dry.

5.2.2        Before taking Rinse / Swab sample, equipment shall be visually cleaned and free from odour.

5.2.3        After taking Rinse / Swab sample, IPQA officer shall be checked sample for particulate matter and odour, sample comply for particulate matter and odour, then sample send to QC for further analysis, if particulate matter or odour is present in sample inform to production officer to re-clean the equipment and again take the sample.

5.3  The production officer shall intimate to the QA officer for sampling of Rinse water / swab as per the Swab/Rinse Analysis Request format which is a part of respective Product Batch Record.

5.4  For Loan License Products where the Batch Records are given by the party, the Swab/Rinse request shall be given as per format No. F/QA-010-01.

5.5  After receiving the request, QA officer with labeled bottles, test tubes and swabs will proceed for the collection of samples. The samples should be collected as per the format No.: F/QA/010-02.

5.6  Procedure for Sampling of Rinse water for analysis:

5.6.1        Clean the equipment as per the respective SOP. Ensure visually clean that the equipment is free from any residue. Collect about 100 ml of sample, for each active ingredient to be estimated in labeled amber coloured bottle, from the final washing collection of the contact part of the equipments / Container/ Accessory.

5.6.2        If Rinse sample is not collected from final washing than collect the sample as below   Procedure.

5.6.2.1  Rinse the equipments through sprayed rinse solution from top to bottom and collect the sample.

5.6.2.2  Rinse solution quantity depends upon the capacity of equipments.

Taking rinse solution as per below mention qty.

100 ltr to 250 ltr rinse solution Approx 1 ltr

251 ltr to 500 ltr rinse solution Approx 2 ltr

501 ltr to 1000 ltr rinse solution Approx 3 ltr

More than 1000 ltr rinse solution Approx 5 ltr.

5.7  Procedure for Sampling of swab for analysis:

5.7.1        Swab sampling shall be carried out using cotton swab. Swab samples shall be taken from equipment/ container surface as per the photograph.

5.7.2        All swabs will be pre-wetted with solvent properly. The surface area to be swabbed is 100Cm² (10cm x 10cm) Swabbing is done in painting motion across the surface, first applying the swab in a vertical motion, and then applying the swab (after rotating it 90°) in an horizontal motion than dip the swab cotton in 10ml purified water.

5.7.3        If area is not sufficient for swab, take tentative area for example Die and punch, RMG Impeller & Chopper blades, multimill inside Housing, small spares and screens Octagonal blender butterfly valve and baffle and Coater Spray gun  assembly, Baffle,  Discharge Chute, Impeller of holding tank, Stirrer of homogenizer etc.

 

 

 

 

 

 

 

 

 

 

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5.8  Rinse water / Swab sample analysis:

5.8.1        The samples shall be immediately transferred to quality control department, along with    Rinse water / swab analysis request cum report.

5.8.2        After the receipt of the Rinse water / swab analysis request and the sample, the quality control department shall allot a unique QC Reference number to the Rinse water / swab   analysis request cum report.

5.9  It shall be brought to the Quality Control Department where an A. R. No. is allotted as follows PQC/ST/XYYY, PQC/RT/XYYY

Where

PQC-Stands for Preet Quality control-

ST-Stands for Swab test

RT- Stands for Rinse water

X-Stands for the current year like 8 for 2018 year

YYY-Stands for serial number of the test performed in a particular year

5.10 If only visually checking for clarity and any presence of particulate matter in the solution is required, (e.g. in case of Batch to Batch Changeover – Type “A” cleaning) than such samples shall be checked by IPQC personnel, while the samples requiring the chemical analysis shall be analyzed by the QC Department. If the same product is in the process then after 72 hrs (irrespective of how many batches manufactured) the complete change over will be done (Type “B” cleaning). But there is no need for sending the swab/rinse water sample to QC.

5.11For the samples requiring the visual cleanliness check, following steps shall be followed:

5.12The sample from the bottles shall be first transferred in the 250 ml capacity clear glass beaker, along with the same amount of the purified water in another 250 ml capacity clear glass beaker.

5.13          Samples shall be checked visually respectively from top and side of the beaker. The sample which requires chemical analysis shall be analyzed by QC as per the respective SOP. After the clearance of the samples by QC / IPQC reports shall be compiled and sent to IPQA for final review. The IPQA shall issue the approved report to the Production department.

5.14          If the Rinse water / analysis does not meet the acceptance criteria, then the investigation shall be carried out as per the SOP for Deviation Handling and the corrective and preventive actions shall be mentioned. The equipment shall be cleaned again and sample sent to QC for reanalysis.

5.14.1    Tacking swab/ Rinse location as per the below photograph.

 QA officer check all the dead spots area / hard to clean area visually as per Photographs for cleanliness before taking swab or Rinse.

5.14.2    QA Officer shall be take rinse from final washing  through discharge chute if rinse is not collect then take swab from RMG Impeller  & Chopper blades and inside  of Discharge chute  are cleaned as per as per Photograph.

 

        

 

 

 

5.14.3    QA Officer shall be take rinse from final washing  through discharge chute if rinse is not collect then take swab from inner surface , Discharge chute from inside of  Mechanical sifter and sieves edges as per as per Photograph.

                    

 

 

 

 

5.14.4    QA Officer shall be take swab from multimill Discharge chute from inside Housing, small spares and screens as per Photograph.

 

 

                                       

 

        

5.14.5    QA Officer shall be take rinse from final washing  through drain point if rinse is not collect then take swab from FBD  lower plenum, view window, dutch mesh corner as per Photograph.

 

 

5.14.6    QA Officer shall be take rinse from final washing  through butterfly valve if rinse is not collect then take swab from octagonal blender rubber gasket, butterfly valve and baffle as per Photograph

5.14.7    QA Officer shall betake swab from Upper and lower turret and five die hole as per Photograph.

5.14.8    QA Officer shall betake swab from Punch tip, Die And Discharge Chute as per Photograph                       

5.14.9    QA Officer shall betake swab from De-duster screen and Discharge chute as per Photograph                     

5.14.10QA Officer shall be take swab Spray gun  assembly, Baffle, Discharge Chute, Discharge Chute Cover, Outlet of holding tank, Impeller of holding tank Inlet & outlet of colloidal mill , Stirrer of homogenizer as per Photograph

 

            

 

          

5.14.11Acceptance Criteria :

The acceptance criteria for the clearance of the Rinse water/ swab samples shall be as follows          

Type of analysis	Acceptance criteria
UV Spectrophotometer (Absorbance between 200 to 800 nm )	Not more than  0.05 ABS
Visual Checking	Sample should be free from foreign particles and odorless.

5.14.12Frequency: Product change over

 

6.0     LIST OF ANNEXURE AND FORMATS:

Sr. No.	Title of Format	Format No.
01	Swab / Rinse water analysis request/report	F/QA-010-01
02	Swab / Rinse Sample Point	F/QA-010-02

 

7.0     REFERENCE:

7.1  SOP-QA-001

7.2  F/QA-001-01

 

8.0     REVISION HISTORY:

Sr. No.	Date	Reason for Revision	Revision No
1.	31/10/2018	New SOP	R0
2.	31/10/2020	Schedule Revision	R1

 

9.0     ABBREVIATIONS:

Sr. No	Abbreviations	Details
01	SOP	Standard operating procedure
02	UV	Ultraviolet
03	IPQC	In-process Quality Control
04	QC	Quality Control
05	ABS	Absorbance
06	Ltr	Litre
07	Ml	Milli liter
08	Nm	nanometer

 

END OF DOCUMENT

SWAB / RINSE ANALYSIS REQUEST / REPORT

 

 

From: Production Department.                                                                                      Date:

                                               

To: Quality Assurance                                                                                                  

 

Product Name:                                                                                                                              Batch No.:

 

Please collect the Swab / Rinse sample for residual analysis as applicable.

 

Sr. No.	Date	Time	Equipment Name	Equipment I.D. No.	Previous Product Name	Previous Batch No.	A.R. No.	Result

 

 Analysis results attached