SOP on Monitoring of Bioburden of Packing material

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1.0 Objective:

1.1 To lay down the procedure for monitoring of Bioburden of Packing material.

2.0 Scope:

2.1 This SOP is applicable for monitoring of Bioburden of Packing material at pharmaceutical for.

3.0 Responsibility:

3.1 Microbiology Chemist or above

3.2 QC Chemist or above

4.0 Accountability:

4.1 Head – Microbiology.

4.2 Head – QC.

5.0 Procedure:

5.1 Sampling:

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 Analysis:

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 Limits:

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:

S.

No.

Format Title Format

Number

Annexure

Number

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.

9.0 Abbreviation:

9.1 SOP :           Standard Operating Procedure

9.2 LAF :                 Laminar Airflow

9.3 CFU :                 Colony forming Units

Annexure-01

Material Name: Plain Aluminium foil/ Printed Aluminium foil / PVC film / PVDC film
Vendor Name:

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

(Microbiology Lab.)

 

Annexure-02

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

 

Annexure-03

                                                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

 

Test Results:

Sr.

No.

Media Name Microbial counts Observed
Bacterial Count Fungal Count
1.

 

Soyabean Casein Digest Agar

 

Limits :

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 :

2 COMMENTS

  1. Dear sir,
    This SOP for bioburden on packing material is according to which guideline the limits are selected?? FDA will ask this question.
    Pl. guide me.

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