Performance Qualification of Ampoule/Vial Washing Machine

Performance Qualification of Ampoule/Vial Washing Machine

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.