sop for monitoring of personnel in aseptic area
1.0 OBJECTIVE :
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.
2.0 RESPONSIBILITY:
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.
3.0 ACCOUNTABILITY:
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
5.0 REASON FOR REVISION :
Change in Environmental monitoring Plan.
6.0 TRAINING :
Trainer — Executive – Quality Assurance
Trainees — Microbiologist and QA Inspectors
7.0 DISTRIBUTION :
Certified Copy No. 1 : Head of Department – Quality Control
Certified Copy No. 2 : Microbiology Department .
Original Copy : Head – QUALITY ASSURANCE.
9.0 REFERENCES:
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 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 microbiological testing of water
sop for depyrogenation of apparatus
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
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