Surface Monitoring by swab method

1.0 Objective
To lay down a procedure for Surface monitoring by swab method.
2.0 Scope
This Standard Operating Procedure is applicable for the Surface monitoring by swab method to

be followed at formulation plant of abc company.
3.0 Responsibility
3.1 Officer / Executive Quality Control Department are responsible for Surface monitoring by swab method.
3.2 Head Quality control is responsible for the compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control
No. : Number
IPA : Isopropyl alcohol
SS : Stainless Steel
LAF : Laminar Air Flow
PP : Polypropylene
SCDA : Soyabean Casein Digest Agar
STA : Sterility Testing Area
ml : Milliliter
MLT : Microbial Limit Test
μl : Micro liter
% : Percentage
ºC : Degree Centigrade
NS : Normal saline
UV : Ultra violet
5.0 Procedure
5.1 Preparation of Swab Before Sampling Operation
5.1.1 Take sterile Cotton swab and remove the tube containing swab from the polypack and take out the swab.
5.1.2 Add 1 ml of 0.9% normal saline solution in the PP tube Ensure the swab tip is completely dip

in N.S. solution. Prepare similarly the necessary amount of swab tubes as per the sampling locations

and autoclave it as per SOP No.
5.1.3 Cool all the swab tubes.
5.1.4 Mark the swab tubes with the respective sampling locations with the help of marker pen.
5.1.5 If the swab tube is not in use then store in incubator at 20ºC – 25 ºC.
5.2 Monitoring Procedure by Swab
5.2.1 Enter the area as per respective area SOP.
5.2.2 Transfer the Cotton swabs to sterile area through cleaned hatch box with UV in “ON”

position or through airlock rooms.
5.2.3 Monitor the required equipment or sterile gown surface by swabbing an area uniformly

and horizontally in one direction. Clean the swabbed areas with 70% IPA solution and allow it to dry.
5.2.4 Replace the swab inside the sterile Tube immediately. Repeat similar swabbing operations

for all sampling locations. After swabbing operations are over, bring all the tubes containing swabs

dipped in normal saline to the microbiology laboratory and transfer to MLT area for further testing.
5.2.5 Now shake the normal saline of each tube reciprocally in such a way that any particles struck

on the swab surface should get dispersed properly in the normal saline.
5.2.6 Now remove the swab gently under LAF and pour the normal saline on the sterile Petri plate

marked with sampling location with permanent Marker pen. Pour gently approx. 15-20 ml of

autoclaved SCDA media on the plate and rotate the plate in order to mix the contents. Proceed

similarly for all other swab sampled tubes.
5.2.7 Allow the plates to solidify under LAF and after solidification transfer all the solidified plates

representing each swabbed sample location for incubation in inverted position in a BOD

Incubator at 20ºC to 25ºC for 72 hours and followed by incubated at 30ºC to 35ºC for 48 hours.
5.2.8 Following incubation period, examine all Petri plates under colony counter and count the

number of colonies for each sampled area and note the readings in a proper authorized format.
6.0 Forms and Records
6.1 Surface Monitoring of Aseptic Area by Swab Sampling Method – Annexure-1
6.2 Surface Monitoring of Sterility Testing Area by Swab Sampling Method – Annexure-2
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Control
8.0 History

Revision Number	Details For Change	Reason for Revision
00	New SOP	NA

Surface Monitoring by swab method

Reason for Revision

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