Bioburden of Packing Material
1.0 Objective
To lay down a procedure for determination of Bioburden in packing materials.
2.0 Scope
This Standard Operating Procedure is applicable for determination of Bioburden in packing materials to be followed at formulation plant of abc company.
3.0 Responsibility
3.1 Officer / Executive Quality Control are responsible for determination of Bioburden in packing material.
3.2 Head Quality Control is responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
IPA : Isopropyl Alcohol
ML : Mille Liter
C : Degree Centigrade
µ : Micron
SCDA : Soyabean Casein Digest Agar
Min : Minutes
Sqrs : Square
Hrs : Hours
5.0 Procedure
5.1 Prepare the pre-sterilized and pre-incubated settle plates of SCDA media.
5.2 Prepare the 100 ml normal saline in two conical flask and autoclave it.
5.3 Check the Bio-burden of the Primary packaging materials only, i.e. Aluminium, PVC foils,
bottles or containers with caps etc.
5.4 For aluminium foils & PVC film:- Take a piece of 5 x 5 square cm with the help of
sterilized scissor and put it into 100 ml Sterilized saline. Ensure label for the details of:
a. Name of the sample
b. AR No.
c. Date of analysis
5.5 For bottles or containers with cap: – Take one piece of container or bottle with cap
and transfer 10ml of saline solution to the container or bottle.
5.6 Shake the flask / container or bottle gently to recover the bio-burden into the saline for 8 to 10 min.
5.7 Perform the testing by membrane filtration method.
5.8 Filter the contents of the flask through 0.45 µ sterilized membranes. After
filtration wash the membrane with 100 ml sterile saline solution.
5.9 Aseptically remove the membrane from the cup using sterilized forceps and
transfer to the surface of the Soyabean Casein Digest Agar plates.
5.10 Incubate the plates at 20-25 C for 72 hrs for total yeast & mold count
followed by 30-35C for next 48 hrs for total bacterial count.
5.11 After incubation observe the plates for bio-burden and record the observations in record
of “Bioburden testing of Primary Packaging materials”,
5.12 Carry out the Microbiological bio burden analysis of primary Packaging Material for first
three consignments at the time of vendor approval and every 20th consignments of approved material.
5.13 Acceptance limit criteria
Total Bacterial Count: NMT 25 cfu per Bottles or Containers with cap/Aluminium Foil/PVC Foil.
Total Fungal Count: Nmt 5 Cfu per Bottles or Containers with cap/Aluminium Foil/Pvc Foil.
6.0 Forms and Records
6.1 Microbiological Analysis of packaging materials – Annexure-1
6.2 Bio-Burden of Report – 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 |
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
Preparation Filtration Usage and Destruction of Disinfectant Solution
Entry Exit and gowning Procedure in Microbiology Laboratory
Safety measures to be followed in microbiology laboratory
Growth Promotion Test of Media
Preservation and Maintenance of Microbial Strain
Entry and Exit in Microbiology Sterile Area
Entry and Exit in Microbiology Limit testing area
Water sampling of raw water purified water WFI and PSG in microbiology Lab
Microbial monitoring of Drain points
Depyrogenation of Glassware and Apparatus
