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SOP for Testing for Bioburden of Fractional Solutions


Standard operating procedure to check the bio-burden of fraction solution before sterile filtration.

1.0  OBJECTIVE

       To check the bio-burden of fraction solution before sterile filtration.

2.0  SCOPE

       This procedure is applicable to fraction solution of insulin product.

3.0  RESPONSIBILITY

3.1  Doing      :  Technical Assistant (Microbiologist)/Executive
3.2  Checking :  Executive/ Manager

4.0  ACCOUNTABILITY

 Head of the Department

5.0  PROCEDURE

5.1  Frequency

5.1.1  Each fraction of each product of insulin is to be taken for testing per month.

5.2  Sampling

5.2.1  Samples for testing are been send by Parenteral Dept. which should not be less than 100ml.

5.3  Preservation of sample

       After sampling, the samples is kept at 2 to 8°C in refrigerator if analysis cannot be performed within 8 hrs. The testing must be completed within 24 hours of sampling.

5.4  PROCEDURE :

5.4.1  The testing procedure is carried out under LAF aseptically.
5.4.2  The testing of sample carried out as specified method for specified product as given below

Name of product
Name of solution
Method used
Mixtard
Preservative, Buffer 
B
Preservative, Protamine & Insulin solution
D
Protamine solution, Preservative Buffer& Insulin Solution
D
Human Mixtard
Preservative Buffer solution
B
Preservative, Protamine & Insulin solution Buffer& Insulin solution
D
Human Monotard
MPO solution
E
Insulin solution
C
NaOH solution
B
Insulin , MPO & Buffer solution
C
Human  Insulatard
Preservative  Buffer solution
B
Preservative Protamine & Insulin solution
D

Lentard
Insulin solution
C
Buffer solution
B
Zn MPO solution
A
Buffer solution
B

Actrapid
Preservative solution
B
Insulin solution
C
NaOH solution
B
Human Actrapid
NaOH solution
               B


5.5  Preparation of Plates
5.5.1  Prepare the plates as per SOP.

5.6  METHOD - A

5.6.1  Membrane filter: -Nitrocellulose
5.6.2  Transfer 100ml sample to membrane filter & filter immediately.
5.6.3  Wash the membrane filter by passing through the filter 3 X 100ml Buffer
5.6.4  Transfer the membrane filter to the surface of a plate of TSA (SCD agar).

5.7  METHOD - B

5.7.1  Membrane filter :- Durapore
5.7.2  Transfer 100ml sample to a membrane filter & filter immediately.
5.7.3  Wash the membrane filter by passing through the filter 3 X 100ml Buffer
5.7.4  Transfer the membrane filter to the surface of TSA (SCD agar).

5.8  METHOD - C

5.8.1  Membrane filter :- Nitrocellulose
5.8.2  Transfer 100ml sample to a membrane filter & filter immediately.
5.8.3  Wash the membrane filter by first passing through the filter 10ml of  0.01 %  w/v ascorbic acid solution in 0.9 % w/v NaCl.
5.8.4  Then pass through the filter 2 x 100ml Buffer
5.8.5  Transfer the membrane filter to the surface of a plate of TSA (SCD agar)

5.9  METHOD - D

5.9.1  Membrane filter :- nitrocellulose
5.9.2  Transfer 100ml sample to a membrane filter and filter immediately.
5.9.3  Wash the membrane filter by first passing through the 10ml of  0.01 1 w/v ascorbic acid solution in 0.9 % w/v NaCl .
5.9.4  Then pass through the filter 2 x 100ml Buffer
5.9.5  Transfer the membrane filter to the surface of a plate of TSA (SCD agar).

5.10  METHOD - E

5.10.1  Membrane filter :- Nitrocellulose  
5.10.2  Transfer 100ml sample to a membrane filter and filter immediately .
5.10.3  Wash the membrane filter by passing through the filter 3 x 200ml Buffer
5.10.4  Transfer the membrane filter to the surface of TSA.

5.11  INCUBATION

5.11.1  Incubate at 30-35° for 5 days.
5.11.2  Count the number of colonies bacterial/fungal and report as cfu/100ml in Annexure-I
            Limit  : Not more than 10 cfu/ 100 ml
            Fungal colony should be absent. 

6.0  ABBREVIATIONS

6.1  SOP - Standard Operating Procedure

ANNEXURE-I

QUALITY CONTROL DEPARTMENT

MICROBIOLOGY LAB
BIOBURDEN OF FRACTIONAL  SOLUTION
                                    
Name of Material:
Batch No:
Date of test: 
Sampling Quantity:
AR.  No:
Method:  Membrane filtration
Slip No:
Medium:  Soyabean casein Digest agar 
Medium Lot No.:
Incubation Temp: 30°C  - 35°C
Incubation period: 5 days
Method No.:

Procedure:                        
(1)  Take 100 ml sample and filter aseptically through the filter specified in method.                                           
(2)  Wash the filter by passing the rinsing fluid specified in method.
Result:
Limit:  Not more than 10 cfu / 100ml.
            Fungal colony should be absent.
Remark:


Microbiologist
Date Of Completion
Checked By
Sign & Date
Sign & Date
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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