CEPHALOSPORIN PRODUCTION FACILITY, RENATA LIMITED
STANDARD OPERATING PROCEDURE (SOP)
PAGE COLLECTING SWAB OR RINSE SAMPLES FOR CHEMICAL AND
1/9 MICROBIOLOGICAL ANALYSIS
SOP NO. EFFECTIVE FROM REVIEW BEFORE SUPERSEDED
RRJ/CPF/SOP/QC/044/08 12.12.21 12.12.24 RRJ/CPF/SOP/QC/044/07
DISTRIBUTION
1. Head of QA.
2. Quality Control (QC) Manager.
3. QC Laboratory.
4. Microbiology Laboratory.
5. IPQC (In-Process Quality Control) Room.
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1.0 Purpose: To establish a standard procedure for collecting swab or rinse samples for chemical and
microbiological analysis.
2.0 Responsibility:
2.1 Quality Assurance (QA) and Quality Control (QC) Personnel: QC and QA personnel are responsible to
CEPHALOSPORIN PRODUCTION FACILITY, RENATA LIMITED
STANDARD OPERATING PROCEDURE (SOP)
PAGE COLLECTING SWAB OR RINSE SAMPLES FOR CHEMICAL AND
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SOP NO. EFFECTIVE FROM REVIEW BEFORE SUPERSEDED
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follow the procedure.
3.0 Accountability: Quality Control Manager.
4.0 Applicability: This SOP is applicable for taking swab or rinse samples from any accessible part of an
equipment, accessories and change part’s surface for chemical and microbiological analysis.
5.0 Definitions and Abbreviations:
5.1 xx: Current Version of a Document.
5.2 CFU: Colony Forming Unit.
5.3 IPA: Isopropyl Alcohol.
5.4 WFI: Water for Injection.
6.0 Associated Documents:
6.1 SOP for Sanitization and Carrying Environmental Monitoring Utensils from Laboratory to Aseptic Area
(RRJ/CPF/SOP/QC/MB/031/xx).
6.2 SOP for Autoclave Systec Model: D150-2D (RRJ/CPF/SOP/QC/MB/006/xx).
7.0 Training Requirements: All concerned personnel in Quality Control Laboratory, Microbiology Laboratory and
QA Department are required to be trained in this SOP.
8.0 Procedure:
8.1 For Chemical Analysis:
8.1.1 Put on clean latex hand gloves.
8.1.2 Remove a swab from its protective bag.
8.1.3 Soak the swab stick (non-sterile) in the purified water or any other solvent (e.g. mobile phase
which is appropriate) and squeeze the swab(s).
8.1.4 Hold the stem of the swab without touching the head of the swab.
8.1.5 Wipe the surface area (5x5 cm2) of the equipment with the (8.1.3) squeezed swab stick.
8.1.6 Wipe the test surface of 25 cm 2 with 10 firm horizontal strokes as illustrated in (8.1.7), using one
side of moistened swab. Lift the swab carefully at the end of each stroke.
8.1.7 Wipe the test surface of 25 cm2 with 10 vertical strokes as illustrated in the following figure,
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using other side of the moistened swab. Lift the swab carefully at the end of each stroke.
Figure 1: Pictorial Illustration of collecting Swab.
8.1.8 Transfer the swab into the transport container (screw capped test tube) without touching the
head of the swab to prevent contamination and close the screw cap.
8.1.9 If it is difficult to take swab sample for critical equipment or change parts, then collect the rinse
sample from that equipment or change part using diluent which is used in residue analysis.
8.1.10 Fill up the “Chemical Analysis Request form for Swab or Rinse Sample (Annexure-l)” and send
it with collected swab/rinse sample to the Quality Control Laboratory for chemical Analysis.
8.1.11 Extract the residue from the swab sample by sonication using proper diluents of respective
product which is used during analysis as per respective methods.
8.1.12 After completion of analysis, report the result.
8.2 Sampling and Testing Procedure for Microbiological Analysis:
8.2.1 For the microbiological analysis always use sterilized swab stick.
8.2.2 To prepare sterile swab stick: infuse a swab stick into a test tube and close the open part with
cotton or screw cap and sterilize with autoclave as per SOP: RRJ/CPF/SOP/QC/MB/006/xx.
Figure 2: Swab stick into test tube.
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Figure 3: Non-sterile swab stick.
8.2.3 Or use pre-sterilized swab stick (commercially available) for sample collection.
Figure 4: Commercially available sterile swab stick.
8.2.4 Select the area from where swab sample should be collected.
8.2.5 Transfer the sterile swab stick to the sampling location as per SOP:
RRJ/CPF/SOP/QC/MB/031/xx.
8.2.6 Put on clean latex hand gloves and rub the hand with 70% IPA.
8.2.7 Remove a swab from its protective bag using a microbiological concept
8.2.8 Avoid touching the swab head to prevent its contamination.
8.2.9 Take out sterile swab stick from the cover and dip it in WFI (Water for Injection) or 0.9% normal
saline or sterilized sampling solvent and allow the swab to be soaked completely.
8.2.10 Take out the swab from sampling solvent and squeeze the tip against inner surface of test tube
to remove excess solvent in such a manner that excess solvent drips inside the test tube.
8.2.11 Hold the stem of swab without touching the head of the swab.
CEPHALOSPORIN PRODUCTION FACILITY, RENATA LIMITED
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PAGE COLLECTING SWAB OR RINSE SAMPLES FOR CHEMICAL AND
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SOP NO. EFFECTIVE FROM REVIEW BEFORE SUPERSEDED
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8.2.12 Using one side of moistened swab; wipe 5x5 cm2 area using parallel and vertical overlapping
stroke with slow rotation of swab with 10 firm strokes as illustrated below:
Figure 5: Swab sampling technique.
Figure 6: Swab sampling from machine parts.
Figure 7: Swab sampling area.
8.2.13 At the end of each stroke, lift the swab carefully.
8.2.14 Write the location and date of swab with marker on tube.
8.2.15 Hold the stem of the swab without touching the head of the swab and let the swab drop into the
transport container. Plug the transport container swab and send to the Microbiology Laboratory for
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STANDARD OPERATING PROCEDURE (SOP)
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microbiological analysis.
8.2.16 If it is difficult to take swab sample for critical equipment or change part, then collect the rinse
sample from that equipment or change part using water for injection.
8.2.17 Fill up the “Microbiology Analysis Request form for Swab or Rinse Sample (Annexure-Il)” and
send it with collected swab/rinse sample to Microbiology for analysis.
8.2.18 For analysing Swab sample of sterile filling area, immerse the sample with 10 ml of sterile 0.9%
saline containing beta-lactamase for neutralization of beta-lactam component (prepared as per
manufacturer’s instruction) and wait for 10 minutes.
8.2.19 Then gently vortex for one minute.
8.2.20 Perform the test by membrane filtration method.
8.2.21 For analysing Swab sample of non-sterile area, immerse the swab stick with 1 ml of sterile 0.9%
saline containing beta-lactamase (prepared as per manufacturer’s instruction) for wait for 1 minute.
8.2.22 Streak the sample on the surface of agar media.
8.2.23 Always use a negative control.
Figure 8: Swab sample streaking technique on agar media surface.
Figure 9: Streaking diagram on the agar media surface.
8.2.24 Mark and incubate the plates at 22.5 ± 2.5°C for 3 days followed by 32.5 ± 2.5°C for 2 days in
CEPHALOSPORIN PRODUCTION FACILITY, RENATA LIMITED
STANDARD OPERATING PROCEDURE (SOP)
PAGE COLLECTING SWAB OR RINSE SAMPLES FOR CHEMICAL AND
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SOP NO. EFFECTIVE FROM REVIEW BEFORE SUPERSEDED
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inverted position.
8.2.25 After incubation, observe and count the plates for number of colonies under light source with
the help of marker.
8.2.26 Interpretation of Results: Results should be interpreted as per following table:
Specification-EU GMP
CFU / 25 cm2
Class area At rest In operation
Class A <1 <1
Class B <1 5
Class C 5 25
Class D 25 50
9.0 Annexure:
9.1 Chemical Analysis Request Form for Swab or Rinse Sample (Annexure – I).
9.2 Microbiological Analysis Request Form for Swab or Rinse Sample (Annexure – II).
10.0 Reference: In-house.
11.0 Revision Record:
CEPHALOSPORIN PRODUCTION FACILITY, RENATA LIMITED
STANDARD OPERATING PROCEDURE (SOP)
PAGE COLLECTING SWAB OR RINSE SAMPLES FOR CHEMICAL AND
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SOP NO. EFFECTIVE FROM REVIEW BEFORE SUPERSEDED
RRJ/CPF/SOP/QC/044/08 12.12.21 12.12.24 RRJ/CPF/SOP/QC/044/07
S/N Revision No. Revision Date Reason(s) for Revision
01 00 N/A N/A
02 01 07.01.12 1. Schedule Review
1. Schedule Review
2. Changes in overall alignment according to new version of SOP for
writing SOP
03 02 18.01.14
3. Changes the Title of SOP.
4. Addition of sub section 5.4, 5.6, 5.9, 6.1 and 6.2.
5. Abolish of section 5.9
S/N Revision No. Revision Date Reason(s) for Revision
1. Overall changed in the procedure. Procedure of collecting swab
described in two subsections. For chemical analysis 5.1 and 5.2 for
microbiological analysis.
04 03 28.06.14 2. One Annexure has been included. Pictorial illustration of collecting
swab (Annexure lV).
3. Changed training record sheet with the new format which is in
Annexure lV.
1. Schedule Review
2. Replacement of “Head of Quality Assurance” with “Quality
Assurance Manager”.
3. Replacement “Reasons(s) for Changes” with “Revision Record” in
section 8.0.
4. Overall content change as per latest version of SOP for writing SOP
05 04 25.05.16
and the changes are as follows-Inclusion of “RENATA Logo”, font
size from 13 to 15 and 15 to 13 respectively in the header, effective
and review date format from mmm, yyyy to DD-MMM-YYYY,
exclusion of training record sheet (previous annexure VI) and review
sheet (previous annexure VII) and inclusion of a new column as
“Revision Date” at section 8.0
CEPHALOSPORIN PRODUCTION FACILITY, RENATA LIMITED
STANDARD OPERATING PROCEDURE (SOP)
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SOP NO. EFFECTIVE FROM REVIEW BEFORE SUPERSEDED
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S/N Revision No. Revision Date Reason(s) for Revision
1. Overall format changes as per latest version of SOP for writing SOP
(RRJ/CPF/SOP/QA/001/xx)
2. Changed in section 3.0. QA Manager was replaced with QC
Manager.
06 05 07.02.18 3. Attach the Figure 1, of pictorial illustration of collecting swab in
section 8.1.7 it was replaced with Annexure-IV.
4. The format of the current annexure – I and II were changed.
5. ‘Cleaning Validation (Machine Surface)’ part of the article 8.2.24 was
removed.
07 06 28.02.21 1. Schedule review.
1. Inclusion of Purified Water in place of Diluent in Sub-section 8.1.9.
08 07 08.12.21
2. Inclusion of subsection 8.2.16 and 8.2.17.
RAISED BY CHECKED BY AUTHORISED BY
Md. Sher Ali Sharif Mahmud A K M Zahedul Islam
Sr. Asst. Manager, QC Additional Manager, QC Head of QA
D D . M M .Y Y D D . M M. Y Y D D . M M. Y Y
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CEPHALOSPORIN PRODUCTION FACILITY PAGE
RENATA LIMITED 1/1
EFFECTIVE REVIEW APPROVED BY HEAD
REFERENCE SOP NO.
FROM BEFORE OF QA
RRJ/CPF/SOP/QC/044/08 12.12.21 12.12.24
ANNEXURE – I
CHEMICAL ANALYSIS REQUEST FORM FOR SWAB OR RINSE SAMPLE
Product Name: Batch No.:
Sample Collection Date: Room No.:
Time of Collection Equipment Name Equipment ID Sampling Location
Remarks:
Collected by: Checked by:
ANNEXURE – II
CEPHALOSPORIN PRODUCTION FACILITY PAGE
RENATA LIMITED 1/1
EFFECTIVE REVIEW APPROVED BY HEAD
REFERENCE SOP NO.
FROM BEFORE OF QA
RRJ/CPF/SOP/QC/044/08 12.12.21 12.12.24
MICROBIOLOGICAL ANALYSIS REQUEST FORM FOR SWAB OR RINSE SAMPLE
Product Name: Batch No.:
Sample Collection Date: Room No.:
Time of Collection Equipment Name Equipment ID Sampling Location
Remarks:
Collected by: Checked by:
