Sop for swab testing


Sop for swab testing


1.1 The objective of this SOP is to define the procedure for collection and testing of swabs of various surfaces for Bioburden determination as called for in various protocols, studies or SOPs.
2.1 This SOP is applicable for person taking the samples of swabs routine monitoring of aseptic area and analyst performing swab test in Microbiology
3.1 Microbiologist-Quality control- To follow the SOP for fumigation & defumigation
3.2 Head- Quality Control – Training on SOP.
4.1 Head – Quality Control

5.1 USP 35 NF 30 (<1116> Aseptic processing Environments, surface sampling page-705).
6.1 As per procedure

7.1 Materials, Equipment :
7.1.1 Materials: Sterile swabs tubes containing 0.9% normal saline Sterile gloves Filtered 70% IPA Marker pen Soyabean casein digest agar plates Sterile 0.45 micron membrane filter Sterile forceps
7.1.2 Equipments: Autoclave Laminar air Flow 30-350C Incubator 20-250C Incubator Manifold filtration unit
7.2 Preparation of swabs:
7.2.1 Prepare 0.9% normal saline solution and sterilize by autoclaving at 1210C and 15 lbs pressure for 20 minutes.
7.2.2 Pour 5 ml of sterilized normal saline into each of the swab tube.
7.2.3 Wrap the swabs in aluminum foil.
7.2.4 These swab tubes can be stored in refrigerator at 2-80C for 15 days.
7.3 Transfer of Swabs to Aseptic Area:
7.3.1 Take the required quantity of prepared swabs from refrigerator or freshly prepared deliver to pass-box outside the aseptic area.
5.1.1 Enter into the aseptic area following the respective area entry exit and gowning procedure.
5.1.2 Open the pass box door from inside the aseptic area.
5.1.3 Remove the outer aluminum packing of the swabs in pass box and deliver the swabs to aseptic area.
7.4 Procedure for sample collection:
7.4.1 Disinfect the swab tubes and hands with filtered 70% IPA or other suitable hand sanitizer provided.
7.4.2 Unscrew the swab tube cap and remove the swab stick from the tube and rotate the swab around the top portion of the tube to express the excess solution from the swab.
7.4.3 Swab the designated approx 2 inch by 2 inch (24-30 cm2) area by pressing the swab tip to the surface to be sampled.
7.4.4 Move the swab in back and forth motion until the entire designated area has been sampled.
7.4.5 Roll the swab cap in your fingertips exposing a new surface of the swab tip.
7.4.6 Repeat swabbing of the designated area in a top to bottom motion.
7.4.7 Immediately place the swab back in its tube containing sterile normal saline and screw.
7.4.8 Write the Location/Equipment name, date of sampling, and sampled by on the outside surface of swab tube with permanent marker.
7.4.9 Wipe the sampled surface area with filtered 70% IPA solution.
7.4.10 Keep one swab as unused and mark it as process negative control.
7.4.11 Transfer the swabs to microbiology lab for analysis.
7.4.12 Record the following information in format No. Date of Sampling Date of test carried Swab prepared on Sampled by Product In filling Batch No. Remarks
7.5 General Procedure for sample testing:
7.5.1 Follow proper gowning procedure of microbiology lab.
7.5.2 Place the swab samples under LAF after sanitizing with filtered 70% IPA or other suitable sanitizing agent provided.
7.5.3 Ensure that the LAF is turned on at least 15 minutes before start of any work.
7.5.4 Sanitize the LAF work bench with filtered 70 % IPA.
7.5.5 Connect the manifold to the filtration flask and then filtration flask to the vacuum line.
7.5.6 Vortex the swab tube for 30 seconds on vortex mixer to get the cells come in the solution from the swab.
7.5.7 Sanitize the outer surface of sterilized filtration assembly with filtered 70% IPA.
7.5.8 Aseptically remove the butter paper from the filtration assembly and place to the manifold unit inside the laminar air flow hood.
7.5.9 Open the cap of swab tube and transfer the content to the filtration assembly.
7.5.10 Open the knob of the manifold to start the filtration.
7.5.11 Rinse the membrane with 100 ml of 0.1% peptone water or Diluting Fluid A.
7.5.12 After filter the swab sample and rinse the membrane with 100 ml of 0.1% peptone water or Diluting Fluid A.
7.5.13 After completion of filtration open the filtration assembly and aseptically remove the filter and place onto the surface of pre incubated Soyabean Casein Digest Agar in Petri plate.
7.5.14 Incubate the plate at 20-250C for NLT 3 days following the incubation at 30-350C for NLT 2 days.
7.5.15 After incubation record the results as total fungal count (TFC) and total bacterial count (TBC) in format No
7.5.16 If any deviation found in the obtained results from the limits stated below, then intimate it to the production department to take necessary action.
7.6 Frequency:
7.6.1 Swab sampling of fill needles shall be carried out at the end of each batch filling when there is product change over. But in case of batch changeover when the same product of different batch is going to be filled, the sample shall be taken after the completion of complete filling activity when there is no more filling activity.
7.6.2 Swab sampling as a part of routine environment monitoring shall be carried out on the day of operational activities.
7.6.3 Swab sampling of other equipment and for other studies shall be carried out as per the plan and schedule given in the respective study document or protocol.
7.7 Precautions:
7.7.1 During swab sampling swab should not touch any other surface or hand, if happens then don’t use such contaminated swab and sample with a new swab.
7.7.2 Sample should be tested as early as possible after sampling, if not possible it should be stored in refrigerator at 2-80C for not more than 4 hours.
7.7.3 When going to sampling in any area the respective area gowning and entry procedure should be strictly followed.
7.8 Acceptance Criteria

S. No. Location Alert Limit Action Limit
1. Grade A surface like Fill needle, rotating turn table, product hopper, inside surface of rubber plug container and filling LAF surface. 1 cfu/25cm2 1 cfu/25cm2
2. Grade B surface like room floor, wall, door etc. 2 cfu/25cm2 3 cfu/25cm2



SOP : Standard Operating Procedure
QCD : Quality Control Department
IPA : Iso Propyl Alcohol
No. : Number
NA : Not Applicable

ANNEXURE Title of Annexure Format No. of Annexure
ANNEXURE I Swab Test Report



Date & time of Sampling:                                                                                        Sampled By:

Unit/ Block :                                                                                                            Analyzed by:

Date of Analysis             :                                                                                       Date of Result:

Medium used                  :                                                                                       Media Lot No.:

Product in Filling            :                                                                                       Batch No.    :

Incubation Condition :

From-                                            To-                             at   20-25°C          Incubator ID No.:

From-                                            To-                             at   30-35°C          Incubator ID No.:

Sr. No.  

Particulars/ Locations



Filling line I Filling line II Filling line III
1 Fill Needle/ Dosing wheel
2 Filling line surface
3 Rotating Table of vials
4 Inner surface of rubber plugs container
5 Wall of Room
6 Floor of Room
7 Corners of Room
8 Process Negative control TFC-                       TBC-
Acceptance Criteria:                           

Particulars                                  Alert limit CFU/plate             Action limit CFU/plate

Filling line                                                                       <1                                                            1

Inner surface of rubber plug container                            <1                                                            1

Rotating table of  vials                                                     <1                                                            1

Wall of the room                                                               3                                                            5

Floor of the room                                                              3                                                            5

Corner of the room                                                            3                                                            5

Result at 20-250C  read By:                                                     Transferred to  30-35°C By:

Result at 30-35°C  read By:                                                                                    Verified By:

Date:                                                                                                                        Date:

sop for calibration and validation of micro autoclave

sop for Sterility failure investigation

cleaning and operation of discard autoclave

sop for operation of fogger machine

sop for Biological assay of lactic acid bacillus

sop for preparation of culture inoculum

STP for sterility testing of sterile gloves

sop for Operation and calibration of active air sampler

sop for transfer of material for testing and sampling in sterile area

entry & exit procedure in microbiology laboratory

Growth Promotion Test In Microbiology Laboratory

Operation of B.O.D in Microbiology Laboratory

Operation of Horizontal Laminar Air Flow in the microbiology laboratory

Operation and cleaning of Pass Box.

Operation and cleaning of air sampler

Cleaning and Sterilization of Glassware

Analysis of water for microbial load in microbiology lab

Operation and temperature monitoring of Refrigerator

Fumigation of Microbiology Laboratory.

Entry & Exit procedure In Sterility Area

SOP for Microbial analysis of Raw Material Finished Products

SOP for Operation & Calibration of pH meter in Micro Department

SOP for Operation & Calibration of pH meter in Micro Department

SOP Operation and calibration of Hot Air Oven In Microbiology

SOP for operation cleaning & calibration of Digital colony counter

SOP for Operation And Cleaning of Microscope

sop for Media Preparation and Consumption

sop for Receipt Storage and Usage of Culture Media

sop for Cleaning Sanitization And Disinfection In Microbiology

sop for Environmental monitoring of all the Classified area

sop for Handling and Sub culturing of Microbial cultures

sop for Media Growth Promotion Test and various Microbiological test

sop for BOD incubator operation and cleaning

sop sampling of water for microbiological analysis

sop for Disinfectant Efficacy Test

sop for for cleaning and operation of vortex mixture

sop for Temperature & Relative Humidity Monitoring

sop for Operation and Calibration of Heating Block

sop for Sterility Testing of Microbiology

sop for Disposal of Culture Media

sop for Drain point of Microbiology

sop for entry & exit procedure In Microbial limit test and Biosafety

sop for Gram Staining of Bacteria in Microbiology Laboratory

sop for Monitoring of Compressed Air/gases for microbiological analysis

sop for BET (Bacterial Endotoxin) test in Microbiology

sop for receipt storage and Determining the population of Biological indicators

sop for qualification of analyst microbiologist

sop for Bioburden test of Packing materials in Microbiology Laboratory

sop for microbiological assay of erythromycin antibiotic

sop for liquid particle counter

sop for operation and calibration of digital zone reader

sop for monitoring of ultraviolet efficiency LAF and pass box

microbiological assay of cyanocobalamin or vitamin B12

gowning procedure for microbiological testing area

swab testing of various surfaces for bioburden determination

sop for endotoxin challenge test

Hold time study protocol for sterilized media

sop for personnel Qualification protocol for aseptic area

sop for sampling and testing of drain water

Sop for Operation of Airborne Particle Counter

sop for Inoculum Preparation

sop for Validation protocol of steam sterilizer autoclave

sop for pathogen detection from drain point

Sop for Analysis of Raw water Purified water water for injection and pure steam water

sop for preservatives efficacy test

sop for collection and preservation of in house isolated microorganisms

sop for Operation Calibration and Maintenance of Micropipette

Sop for UV Efficacy Test

sop for gram staining

Sop for swab testing

sop for microbiological testing of water


sop for depyrogenation of apparatus

sop for media preparation

sop for fertility test growth promotion test of media

sop for Operation and cleaning of moist heat sterilizer

sop for monitoring by active air sampler

sop for swab sampling and testing for clean rooms in production area

sop for monitoring in microbiology laboratory

sop for Fumigation of aseptic area and microbiology lab

sop for monitoring of personnel in aseptic area

sop for maintenance of cultures

sop for Operation and cleaning of laminar bench

preparation of settle plates

sop for monitoring of pure steam

sop for entry and exit procedure to m.l.t and b.e.t room

sop for storage of and use of media

sop for disposal of microbiological media and cleaning of microbiological glassware


Leave a Comment

error: Content is protected !!