Sterile pharmaceutical preparations as injections are filled in glass vials. These vials should be cleaned properly before filling. Automatic vial washing machines are used to clean but the process of cleaning of the vials should be validated. The efficiency of these machines is verified by following tests.
1. Chloride Content Test:
A 30% solution of sodium chloride is prepared in water. 10 containers or vials are spiked with 0.1 ml of this sodium chloride solution. Containers are swirled to coat the inner surface and evaporate the solution to dryness at room temperature. Spiked test containers are marked in series with permanent marker on the outer surface.
2. Particulate Matter Test:
10 gm of charcoal is dissolved to make 1% charcoal slurry. Approximately 0.1 ml of charcoal slurry is used to spike each of 10 containers by swirling the container to coat the inner surface and evaporate the solution to dryness at room temperature. Spiked test containers with charcoal are marked in series with permanent marker on the outer surface.
3. Bacterial Endotoxin Test:
Add 100 endotoxin units into 10 vials and allow them to dry at 45 - 50°C. Mark these spiked vials with permanent marker on the outer surface.
Separate 10 containers are used for each of above tests.
Procedure: About 3000 vials of the selected size are loaded on the feed belt and vial washing machine is operated as per the standard operating procedure. Place the spiked vials marked with permanent marker in between the other vials while the machine is running. These vials should be placed at the initial, middle and end of the washing session. Collect the marked vials after washing and store properly to avoid the other contamination from the environment. These spiked vials are analyzed separately. It should be done three times for each vial size.
Acceptance Criteria:
1. Sodium chloride content should be absent in any of the spiked vial.
2. Vials should be free from foreign particle & fibers on visual inspection. 10µ particles should not be more than 25 and 25µ particles should not be more than 3.
3. Vials should comply endotoxin limit i.e 0.25 EU/vial.
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Why the BET is part of vial washing validation ?
ReplyDeleteVery Informative. Thank you Mr.Ankur Choudary :)
ReplyDeleteMr. Ankur, your contribution to the pharmaceutical industry is excellent.
ReplyDeleteHi Ankur,
ReplyDeleteCan you please elaborate how particulate matter challenge study to be done for Cartridges. The above given procedure of Charcoal would be feasible for vials, but not for Cartridges as Cartridge have both ends open.