The machine adopts a continuous rotary washing system with precision neck-gripping technology, allowing ampoules to be inverted and cleaned through multiple washing stages. Using purified water, WFI (Water for Injection), and sterile compressed air, the system effectively removes particles, glass residues, dust, and contaminants from container surfaces.<\/p>\n
Designed with GMP-oriented construction, stainless steel materials, and flexible process configuration, the automatic rotary ampoule washing machine can be customized according to container size, production speed, and sterile filling line requirements.<\/p>\n
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 the vials should be validated. The efficiency of these machines is verified by the following tests.<\/p>\n
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 atroom temperature. Spiked test containers are marked in series with a permanent marker on the outer surface.<\/p>\n
2.Particulate Matter Test: 10 gm of charcoal is dissolved to make 1% charcoal slurry. Approximately0.1 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 a permanent marker on the outer surface.<\/p>\n
3.Bacterial Endotoxin Test: Add 100 endotoxin units into 10 vials and allow them to dry at 45 \u2013 50\u00b0C. Mark these spiked vials with permanent marker on the outer surface. Separate 10 containers are used for each of the above tests<\/p>\n
4.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 a 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 theother contamination from the environment. These spiked vials are analyzed separately. it should be done three times for each vial size.<\/p>\n
5.Acceptance Criteria: Sodium chloride content should be absent in any of the spiked vials. Vials should be free from foreign particles & fibers on visual inspection. 10u particles should not be more than 25, and 25u particles should not be more than 3. Vials should comply with the endotoxin limit i.e 0.25 EU\/vial.<\/p>\n
01 DESCRIPTION<\/p>\n
02 SPECIFICATION<\/p>\n
03 FAQ<\/p>\n
04 FEATURE<\/p>\n
05 QUALIFICATION<\/p>","protected":false},"excerpt":{"rendered":"
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