Standard Operating Procedure (Sop) Collecting Swab or Rinse Samples For Chemical and Microbiological Analysis
Standard Operating Procedure (Sop) Collecting Swab or Rinse Samples For Chemical and Microbiological Analysis
Standard Operating Procedure (Sop) Collecting Swab or Rinse Samples For Chemical and Microbiological Analysis
DISTRIBUTION
1. Head of QA.
2. Quality Control (QC) Manager.
3. QC Laboratory.
4. Microbiology Laboratory.
5. IPQC (In-Process Quality Control) Room.
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)
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.
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:
using other side of the moistened swab. Lift the swab carefully at the end of each stroke.
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:
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.
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 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).
01 00 N/A N/A
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
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.
D D . M M .Y Y D D . M M. Y Y D D . M M. Y Y
ANNEXURE – I
CHEMICAL ANALYSIS REQUEST FORM FOR SWAB OR RINSE SAMPLE
Remarks:
ANNEXURE – II
CEPHALOSPORIN PRODUCTION FACILITY PAGE
RENATA LIMITED 1/1
Remarks: