sop for monitoring of personnel in aseptic area


sop for monitoring of personnel in aseptic area



The objective of this SOP is:
1.1 To lay down a procedure for monitoring personnel of sterile area in aseptic area by taking finger and garment dabs by contact plate method.


2.1 The Quality Assurance Personnel shall be :
2.1.1 Responsible for Sampling.

2.2 The Microbiologist shall be :
2.2.1 Responsible for sampling and interpretation of results.

2.3 Executive – Quality Control shall be :
2.3.1 Responsible for checking and approving the results.


Head – Quality Control

4.0 PROCEDURE: Test : By Contact Plate Method .

4.1 Prepare Contact Plate as per SOP ( Use Rodac Plates 40-45 mm in diameter instead off normal plates of 90mm diameter. ) .
4.2 Materials for sampling are transferred into the sterile area as per SOP
4.3 Enter in the respective areas by following the proper entry (gowning) procedure.
4.4 Before entering into the area spray the outer portion of the container followed by moping with a lint free cloth with 70% IPA solution.
4.5 Pre-incubated contact plates of sterile SCDA media are exposed and hand impressions dress impressions (arm-pits , fore-head, fore-arm , belly etc)

are taken at the place of working.
4.6 After taking the contact-plate samples close the lid of the petri –plate and write the name, nature of work and batch number of

the product at the base of the plate.
4.7 Bring those plates to the microbiology laboratory and incubate at 20-25  C for 72 hrs followed by 30-35 C for 48 hrs.
4.8 Observe the plates after completion of incubation period and note the observations in the format giver in monitoring plan.
4.9 Frequency, limits and locations are mentioned in the monitoring plan.
4.10 If the bio-burden is found out of the specified limit ,proceed as per the SOP


Change in Environmental monitoring Plan.

Trainer — Executive – Quality Assurance
Trainees — Microbiologist and QA Inspectors

Certified Copy No. 1 : Head of Department – Quality Control
Certified Copy No. 2 : Microbiology Department .
Original Copy : Head – QUALITY ASSURANCE.

In house

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 !!