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Vial Washing Machine – Importance Of Validation Of Vials

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In sterile pharmaceutical preparations such as required for injectable dosage forms, the drugs are often supplied in glass vials. These should be cleaned before filling, and although automatic vial washing machines may be used to clean vials, it is important to have the cleaning process validated. The efficiency of the washing machine and process is verified by performing several tests, as follows.

Chloride Content Test

To perform the chloride test, a 30% aqueous solution of sodium chloride is prepared. Select ten containers and load 0.1ml of the sodium solution into each vial. The containers are swirled in order to coat the inner surface as well as evaporate the solution to dryness at room temperature. Each of the treated vials is then labelled using a marker pen on the outer surface of the glass.

Particular Matter Test

Charcoal powder (1g) is added to water to make a slurry of 0.1% by weight. The slurry is thoroughly agitated to homogenise the mixture and 0.1ml is then used to spike each of ten containers. The vials are swirled to coat the inside surface and the solution is allowed to dry at room temperature. Spiked containers are then marked in series as above.

Bacterial Endotoxin Test

Place 100 endotoxin units into 10 vials and allow to dry at 45 -- 50°C. Mark the vials the same as the others above. Separate ten vials are used for each of the above tests.

Test procedure

Approximately 3000 vials of the selected size are loaded to the feed belt of the vial washing machine. The machine is operated as per the standard operating procedure. While machine is running, the spiked vials are placed in between the other vials. The vials should be placed before, in the middle and after the washing session. On completion of the wash cycle, collect the marked vials and store them properly to avoid any contamination from the environment. Each vial is analysed separately and this should be done 3 times for each vial size.

Acceptance Criteria

  • Sodium chloride should be absent from all of the spiked vials.
  • Check all vials visually – they should all be clean and free from fibres or particles of foreign matter. There should be no more than 25 10-micron particles, and no more than 3 particles of 25-micron.
  • The vials should comply with the endotoxin limit, i.e., 0.25 EU/vial.

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