Performance
Qualification of Ampoule/Vial Washing Machine
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The ampoule/
vial washer is used to clean the drug container to eliminate the contamination
(endotoxin, chemical substance, particles etc.) from the container itself to
ensure that the products produced meet expectations for purity, identity,
safety, and quality.
Performance
of the ampoule/ vial washer should be qualified at regular intervals. Even though
depyrogenation may be achieved using a heating tunnel or oven, if the washing
process cannot remove chemical contaminants or particles, they will produce a
pyretic response in humans or animals, although there are no pyrogens present.
Thus decontamination studies for endotoxin,
chemical contaminants, and particles should be performed. Each study to
be challenged three times to verify the reproducibility of the machine’s
performance.
Endotoxin Decontamination Study
Inoculate
endotoxin suspension in each testing ampoule/vial ( 10 Numbers) calculated to obtain 100EU/ml. Dry in a oven
at 450C - 600C and 30 mmHg about one hour until no visual
water present. After drying send the spiked ampoule/vials for washing. After
washing send the ampoule/vials to Microbiology lab for testing
Acceptance
Criteria: at minimum, a three-log reduction in endotoxin.
Chemical Decontamination Study (Sodium
Chloride Challenge Test – [Soluble])
Prepare 30% Sodium chloride solution & spike
it in 10 ampoules/vials. Dry the ampoules/vials under LAF for 8-10 hours, after
drying send the
spiked ampoule/vials for washing. After washing send the vials to Quality
control lab for testing.
Acceptance
Criteria: Precipitation & chloride content should be absent in the
ampoules/vials after washing.
Particulate Decontamination Study (White Powder
Talc Solution Challenge Test – [In soluble])
Prepare white powder talc solution & spike
it in 10 ampoules/vials. Dry the ampoules/vials under LAF for 8-10 hours, after
drying send the
spiked ampoule/vials for washing. After washing send the vials to Quality
control lab for testing.
Acceptance
Criteria: 10 µ
particles NMT 25 & 25 µ particles NMT 3
Glass Particle Challenge Test
Take glass
particles and put it in 10 ampoules/vials. After washing
check visually for any glass particles.
Acceptance
Criteria: No
particles shall be observed in the ampoules/Vials after washing.
Note: For each study, the quantity of ampoules/vials
to be washed is the same as normal production size to demonstrate the
performance of the normal process.
