Aseptic Process Validation
(Process Simulation or Media/Broth Fill Trial) SOP
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1.0
PURPOSE:
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1.1. It is established to avoid contamination of
microorganisms during manufacturing of sterile products to ensure aseptic
manufacturing techniques/practices being used by the personal are satisfactory
and capable of producing sterile products..
2.1. This procedure is applicable to liquid
injectable & sterile powder filling areas of production department.
3.1. Quality Control Manager
3.2. Microbiologist
3.3. Production Manager
3.4. Production Pharmacist
3.5. Officer QA
3.6 Manager QA
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4.0 Definitions:
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4.1 Aseptic
Filling:
Operations whereby the product is sterilized
separately, than filled and packed using sterilized containers and closures in
critical processing zones.
4.2 Bioburden:
Total number of viable microorganisms on or in
pharmaceutical products prior to sterilization.
4.3 Media
Fills:
Method of evaluation an aseptic process using a
microbial growth medium (Media fills are understood to be synonymous to
simulated product fills, broth trials, broth fills etc.)
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5.0
FLOW
CHART:
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6.0
DESCRIPTION/PROCEDURE
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a)
Aseptic
Process Validation of Liquid Injectable Area
a.
Prepare desired quantity of
Tryptic Soya Broth (Soyabean Casein Digest Medium) as per manufacturer’s
instruction to fill appropriate number of units but not less than 3000.
b.
Filter the media under the sterile
nitrogen gas pressure using the fiberglass prefilter and 0.2µm cartridge filter
or 0.2 µm membrane filter.
c.
Fill media aseptically performing
all procedures identical to regular manufacturing process except pre & post
purging of sterile nitrogen during filling.
d.
Each operator who normally
participates in the aseptic fill products should participate in the aseptic
fill validation.
e.
Equipment parts that come in
contact with media must be sterile and completely free from any substance that
could inhibit growth of microorganisms.
f.
Incubate the filled ampoules at 20
– 25ºC for 14 days along with positive & negative controls.
g.
Leak testing of ampoules be
carried out before incubation.
h.
Record any contamination must
observe during incubation time.
i.
Sterile sample will contain a
clear yellowish colored liquid free from any sign of turbidity, mold or
bacterial growth.
j.
Aseptic process validation will
meet the requirements if contamination is less than or equal to 0.1%.
k.
Perform swab test of the surfaces
and equipment at the end of the aseptic media fill.
l.
Perform swab test of uniforms of
operators at the end of media filling operation.
m.
Record all the results.
a. Validation
of Aseptic Process (PICS Guidelines)