1.1 To lay down the procedure for monitoring of Bioburden of Packing material.
2.1 This SOP is applicable for monitoring of Bioburden of Packing material at pharmaceutical for.
3.1 Microbiology Chemist or above
3.2 QC Chemist or above
4.1 Head – Microbiology.
4.2 Head – QC.
5.1.1 Sampling of Primary Packaging Material (Aluminium foil, PVC film, PVDC film) shall be performed by QC Chemist as per respective SOP.
5.1.2 Chemist shall maintain the log for Primary Packaging Material as per Annexure No. 01.
5.1.3 First ten lot of each primary packaging material of every new vendor shall be analyzed for bioburden and thereafter every tenth lot shall be analyzed for the same. 1 meter sample of any sampled roll shall be handed over by QC Chemist to Microbiology Chemist for analysis.
5.1.4 Microbiology Chemist shall maintain log for inward of Primary Packaging Material as per Annexure No. 02.
5.2.1 Microbiology Chemist shall aseptically open the RODAC plate and gently press it on the respective material and close.
5.2.2 Incubate the plate at 200C -250C for 72 hours followed by 300C -350C for 48 hours.
5.2.3 Count the number of Bacterial and fungal colonies and express the result as count (CFU) / 30 cm2 as per the Annexure 03.
5.3.1 Bacteria: Not more than 20 CFU/30cm2
5.3.1 Fungi : Not more than 2 CFU/30cm2
6.0 List of Annexure / Formats:
|No. of Pages|
|1.||Log for Primary Packaging Material to be analyzed for Bioburden|
|2.||Inward Log for Primary Packaging Material to be analyzed for Bioburden|
|3.||Bioburden report of Packing material|
7.0 References (if any).
8.0 Reason for Revision:
8.1 Not Applicable due to First version.
9.1 SOP : Standard Operating Procedure
9.2 LAF : Laminar Airflow
9.3 CFU : Colony forming Units
|Material Name: Plain Aluminium foil/ Printed Aluminium foil / PVC film / PVDC film|
Log for Primary Packaging Material to be analyzed for Bioburden
|Sr. No.||Date||Product Name||GRN No.||A.R. No.||To be Tested for
Bioburden (Yes / No)
|Sample given by (QC)||Sample Received by
Inward Log for Primary Packaging Material to be analyzed for Bioburden
|Sr. No.||Date||Product Name||GRN No.||A.R. No.||Date of Analysis Started||Date of Analysis Completed||Analyzed By||Remarks|
Bioburden Report of Packing Material
|Name of the Material||Vendor Name|
|GRN No.||A.R. No.|
|Analysis Started on||Analysis Completed on|
|Media Name||Lot No||Date of Preparation|
Soyabean Casein Digest Agar
|Media Name||Microbial counts Observed|
|Bacterial Count||Fungal Count|
|Soyabean Casein Digest Agar|
Bacterial count Fungal count
NMT 20 CFU/30cm2 NMT 2 CFU/30cm2
Observation :- Bio burden is found within / out of specified limit.
Done by : Checked By :
Date : Date :