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 - 50C. 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. 10 particles
should not be more than 25 and 25 particles should not be more than 3.
3. Vials should comply endotoxin limit i.e 0.25 EU/vial.
TELANGANA STATE ORDER STATUS

S. No. Product Order qty. Qty. packed Remark

1 Oxytetracycline-50 ml 25000 17000 Jail & inner awaited
2 Pheniramine injection 100ml 15000 15000
3 Amikacin injection 30ml 1000 To be packed
4 Tylosin injection 30ml 6500 6500
5 Dexamethasone 5ml 13000 To be packed