Professional Documents
Culture Documents
Aseptic Process Validation
Aseptic Process Validation
1.0 PURPOSE:
2.0 SCOPE:
2.1. This procedure is applicable to liquid injectable & sterile powder filling areas of
production department.
3.0 RESPONSIBILITY:
4.0 Definitions:
Operations whereby the product is sterilized separately, than filled and packed using
sterilized containers and closures in critical processing zones.
4.2 Bioburden:
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.)
5.0 FLOW CHART:
6.0 DESCRIPTION/PROCEDURE
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.
6.0 References: