Efficacy Test Procedure of Antimicrobial Preservatives STANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE |
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Department: Quality Control
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SOP No.: QC/MB/xxxx
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Efficacy Test Procedure of Antimicrobial
Preservatives
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Effective
Date:
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Review
Date:
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Page
No.: 1
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1.0
OBJECTIVE:
1.1
To lay down a procedure for testing the efficacy of the antimicrobial preservatives.
2.0
SCOPE:
2.1
This SOP is applicable to find out the efficacy of the
preservatives added in formulations.
3.0
RESPONSIBILITY:
3.1
Microbiologist –
Responsible for doing the activity.
3.2
QC Head – Responsible for implementing the procedure.
3.3
QA Head – Overall Compliance.
4.0
PROCEDURE:
4.1
Inoculation procedure:
4.1.1
The test conducted in five original containers, if sufficient volume of
product is available in each container, which can be accessed aseptically with
the help of syringe fitted with needle. Otherwise use five sterile capped
bacteriological containers of suitable size in to which a sufficient volume of
product has been transferred.
4.1.2
Inoculate each container with one of the prepared and
standardized inoculum by using
sterile needle or syringe and mix
the content for its uniform distribution.
4.1.3
The volume of suspension inoculum used is between 0.5
% and 1.0 % of the volume of the products.
4.1.4
The concentration of test microorganisms that is added
to the product (categories 1, 2 and 3) are such that the final concentration of
the test preparation after inoculation is between 1x105 and 1x106 cfu per mL
of the product.
4.1.5
The concentration of test microorganisms that is added to the product (categories
4) are such that the final concentration of the test preparation after
inoculation is between 1x103 and 1x104 cfu per mL
of the product. Incubate
the inoculated containers at 20°C to 25°C.
4.1.6
Determine the viable count by using plate count method
at 7th, 14th, 21st and 28th days
subsequent to inoculation (Note: incorporate an in activator of the
antimicrobial preservatives before test).
4.1.7
Record any change observed in appearance.
4.2
Interpretation:
4.2.1
The preservative is effective in the product examined
if result is as follows.
4.2.1.1 The concentration
of viable bacteria is not more than 0.1 % of the initial concentration by the
14th day.
4.2.1.2 The
concentration of viable yeast and molds remain at or below the initial
concentration during the first 14 days.
4.2.1.3 The
concentration of each test organism remains at or below above designated levels
during the remainder of the 28 days test period.
4.2.1.4 Prepare the
report for the efficacy test as per respective protocol.
4.3
Compendial product categories:
Category
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Product description
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1
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Injections, other parenteral
including emulsions, otic products, sterile nasal products and ophthalmic
products made with aqueous bases or vehicles.
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2
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Topically used products made with
aqueous bases or vehicles, non-sterile nasal products and emulsions,
including those applied to mucous membranes.
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3
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Oral products other than antacids,
made with aqueous bases or vehicles.
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4
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Antacids made with an aqueous base.
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5.0
ABBREVIATIONS:
QC: Quality Control
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QA: Quality Assurance
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SOP:
Standard Operating Procedure
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CFU:
Colony Forming Unit
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6.0
ANNEXURES :
6.1
Annexure I - Incubation time and suitable medium
for organisms: Current Version of QC/MB/.
7.0
REFERENCES:
7.1
United States of pharmacopeia chapter <51> Antimicrobial
Effectiveness Testing
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