sop for Bioburden test of Packing materials in Microbiology Laboratory
1.0 OBJECTIVE
1.1 To lay down a procedure for Microbiological Content Test of Packing materials.
2.0 SCOPE
2.1 This procedure applicable for Bioburden test of Packing materials in Microbiology Laboratory
3.0 RESPONSIBILITY
3.1 Officer Microbiologist
3.2 Executive Microbiologist
4.0 ACCOUNTABILITY
4.1 Head –QC
5.0 PROCEDURE
5.1 Requirement
5.1.1 Sterile Normal Saline (0.9%w/v Sod. Chloride Solution)
5.1.2 Sterile Swab sticks which is sterilized in a test tube containing 10 ml Normal saline
5.1.3 Pre prepared SDA (Sabouraud Dextrose Agar) and SCDA (Soyabean Casein Digest Agar) Media as per SOP
5.2 Methodology
5.2.1 Take the pre-sterilized and pre-incubated settle Petri plates of SCDA (Soyabean Casein Digest agar).
5.2.2 Prepare the 100 ml normal saline in two conical flask and autoclave it.
5.2.3 Take pre sterilize Sabouraud Dextrose Agar plates.
5.2.4 Check the Bio-burden of the Primary packaging materials i.e. Aluminium foils, PVC, PVDC foil.
5.2.5 Select the no. of rolls from the consignment. It should be not less than √N + 1 of the total consignment.
5.3 For Aluminium foils/PVC/PVDC
5.3.1 One circular layer of foil is discarded and in next layer an area of approximately 100 sq. cms shall be examined.
5.3.2 Swab the entire internal surface of the sample with the help of a sterile swab stick which is dipped in sterile normal saline (10ml).
5.3.3 Streak the swab on the surface of sterile SDA and SCDA plates (Duplicate Plates).
5.3.4 Incubate the SDA plates at 20 – 25ºC for 5 days and SCDA plates at 30 – 35ºC for 5 days.
5.3.5 After the completion of incubation period record the results.
5.3.6 If the results are not within the specified limit, further sampled some more rolls and analyze.
5.3.7 If again results are not within the specified limit reject the consignment. If one or two rolls are showing
results beyond the specification reject the individual rolls.
5.4 For Bottles or container
5.4.1 Take one piece of container or bottle with cap and transfer 10ml of saline solution to the container or bottle.
5.4.2 Shake the flask/container or bottle gently to recover the bio-burden into the saline for 8 to 10 min.
5.4.3 Perform the testing by Pour plate method.
5.4.4 Transfer 1ml solution in the surface of the SDA and SCDA plates (Duplicate Plates).
5.4.5 Incubate the SDA plates at 20 – 25ºC for 5 days and SCDA plates at 30 – 35ºC for 5 days.
5.4.6 After the completion of incubation period record the results.
5.4.7 If the results are not within the specified limit, further sampled some more bottles and analyze.
5.4.8 If again results are not within the specified limit reject the consignment.
5.5 For Dropper Assembly/Caps
5.5.1 Fill the dropper assembly with sterile normal saline and collect in a sterile conical flask.
5.5.2 In case of PP caps fill the sampled caps with 1-2ml of sterile normal saline and collect the solution in a sterile conical flask.
5.5.3 Transfer 1ml solution in the surface of the SDA and SCDA plates (Duplicate Plates).
5.5.4 Incubate the SDA plates at 20 – 25ºC for 5 days and SCDA plates at 30 – 35ºC for 5 days.
5.5.5 After the completion of incubation period record the results.
5.5.6 If the results are not within the specified limit, further sampled some more bottles and analyze.
5.5.7 If again results are not within the specified limit reject the consignment.
5.5.8 Carry out the Microbiological bio burden analysis of primary Packaging Material for every consignments of approved material.
5.6 Limit Acceptance criteria
6.0 ABBREVIATIONS
QCM : Quality Control Microbiology
SOP : Standard Operating Procedure
QA : Quality Assurance
GTP : General Testing Procedure
QC : Quality Control
CFU : Colony Forming Units
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very good documents