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. 

The 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 is to be challenged three times to verify the reproducibility of the machine’s performance.

  • To establish documented evidence that will provide a high degree of assurance and reliability about the performance of the ROTARY VIAL WASHING MACHINE.
  • To verify the vial washing process is capable of consistently and reliably producing appropriate washing of different types of vials at different speeds encountered in the routine production operations.
  • The Vial washing process is capable of consistently and reliably removing Any chemical traces that may be present on the inner surface of the unwashed vials.
  • Particulate matter contaminants, such as dust, lint, fibers etc.,
  • Endotoxins from endotoxin-spiked vials
  • Soluble dye test (Ethylene blue test)
  • To establish washing cycle parameters under normal and worst-case conditions.

  • The scope of this protocol is limited to carrying out the performance qualification of the Automatic high-speed Vertical Rotary vial washing machine located in the Vial washing room of the injectable section.
  • To be performed after the completion and authorization of Operational Qualification.
  • To be performed at the time of relocation or Requalification.

  • Equipment Identification
  • The subject equipment is identified as: Vial washing machine 
  • The automatic high-speed rotary vial washing machine is located in the Vial washing room for washing various types & sizes of vials.
  • An automatic rotary vial washing machine with an integral washing tank for recycled water, with multiple washing stations, is designed to clean the glass vials internally and externally with different washing media in six stages at the rated output of 120 vials per minute. Operation by the rotary travel system and Control through PLC.
  • Vials are fed onto an in-feed turntable from where they are transferred onto an infeed star wheel and delivered to a revolving conveying system consisting of 26 grippers equally spaced V-gripper are mounted on the circumference of the gripper ring which rotates around a vertical axis.
  • The horizontal rotation of the vial through 180 degrees during the infeed as well as the opening and closing of the grippers is cam controlled.
  • Vials are passed through the cleaning station upside down. At the individual station spray tubes travel is synchronism with vials then position the vials, with orifices exactly centered. The spray tubes follow the continuously moving grippers from the start to the finish of a working station and retract. As long as spray tubes are inside the vials spraying with cleaning media takes place.
  • The cleaning media is collected in the top plate and recirculated. The sequence of washing as follows.
  1. Station - 1: Internal & External recycled water.
  2. Station - 2: Internal compressed air.
  3. Station - 3: Internal Purified water.
  4. Station - 4: Internal compressed air.
  5. Station - 5: Internal WFI.
  6. Station - 6: Internal & External Compressed Air.
  • The vials are withdrawn in a process similar to the entry. The vials are reversed by 180° up & engaged in the slots of an out-feed star wheel from where the vials are pushed back to back to the downline machine.
  • These washed vials are pushed via the dead plate of the vial washing machine onto the tunnel conveyor belt and get distributed evenly in the tunnel-drying zone.
  • The washed vials are covered under a Laminar airflow workstation fixed over the washing machine providing a class 100 environment thereby protecting the washed vials from particulate contamination from the environment.
  • Area description
  • Entry into the Vial washing room/ area is restricted to authorized personnel only and there is a requirement of protective gowning to enter the room.

Endotoxin Decontamination Study
Inoculate endotoxin suspension in each testing ampoule/vial (10 Numbers) calculated to obtain 100EU/ml. Dry in an oven at 450°C - 600°C and 30 mmHg for about one hour until no visual water is present. After drying send the spiked ampoule/vials for washing. After washing send the ampoule/vials to the 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 ampoules/vials for washing. After washing send the vials to the 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 ampoules/vials for washing. After washing send the vials to the 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 them 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 the normal production size to demonstrate the performance of the normal process.

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