Different tests done during the validation of Vial Washing machine
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 outer surface.
Separate 10 containers are used for each of above tests.
Procedure: About 3000 vials of 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 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 environment. These spiked vials are analysed 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.
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 outer surface.
Separate 10 containers are used for each of above tests.
Procedure: About 3000 vials of 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 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 environment. These spiked vials are analysed 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.
