1. Purpose:To lay down the cleaning procedure of S.S. bins, Containers, Pallet, Hosepipes Material transfer pipe and Accessories.
2. Scope:This procedure is applicable to cleaning of:
2.1. S.S. bins & containers.
2.3. Hose pipes.
2.4. Material transfer pipe
3. References & Attachments:3.1. References: In-house
3.2. Attachments: None
4. Responsibility:4.1. Production:
4.1.1. Cleaning of equipment.
4.2. Quality Assurance:
4.2.1. To ensure cleaning of equipment as per defined procedure.
5. Distribution:5.1. Manager Quality (Master Copy)
5.2. Manager Production
5.3. Production Shop Floor (Display Copy)
6. Definitions of terms:6.1. S.S: Stainless Steel
7. Cleaning procedure:
7.1. S.S. bins & plastic containers:7.1.1. Transfer the stainless steel (S.S) bin/container to the washroom.
7.1.2. Wash the S.S. bin/container with potable water.
7.1.3. Clean the S.S. bins/containers with 2%v/v approved non-ionic detergent solution using nylon scrubber.
7.1.4. Rinse the S.S. bins/containers with running potable water to remove the detergent.
7.1.5. Finally rinse the S.S. bins/containers with purified water.
7.1.6. Air dry the S.S. bins/containers.
7.1.7. Store the S.S. bins/clean containers at designated place on pallets.
7.1.8. Use nose mask and hand gloves when handling acids or alkali solution.
7.1.9. In case of container used for
18.104.22.168. Film coating solution, clean the container with 10%v/v glacial acetic acid solution, using nylon scrubber followed by rinsing with potable water twice and purified water once.
22.214.171.124. Enteric coating solution, clean the container with 10%w/v sodium carbonate solution using nylon scrubber, followed by rinsing with potable water twice and purified water once.
7.2. S.S. Accessories, S.S. Scoops, S.S. Spatulas and Measures:7.2.1. Take the accessories to washroom.
7.2.2. Wash the accessories with 2%v/v approved non-ionic detergent solution using nylon scrubber.
7.2.3. Rinse the accessories with running potable water to remove the detergent.
7.2.4. Finally rinse the accessories with purified water.
7.2.5. Store the clean accessories in a dry clean equipment rack and allow it to dry.
7.2.6. In case used for,
126.96.36.199. Film coating solution, clean it with 10% glacial acetic acid solution followed by rinsing with potable water twice and purified water once.
188.8.131.52. Enteric coating solution, clean it with 10% sodium carbonate solution using nylon scrubber, followed by rinsing with potable water twice and purified water once.
7.3. Hosepipes:7.3.1. Transfer the hosepipes to the washroom.
7.3.2. Clean thoroughly each hosepipe with running potable water from one end to the other, both from inner and outer side.
7.3.3. Rinse the hosepipe with 20 litres of running purified water.
7.3.4. Dry the hosepipe using compressed air. Check the cleanliness and drying, and cover the mouth with stretch film.
7.4. Pallets:7.4.1. Transfer the pallet to the washroom.
7.4.2. Wash each pellet with running potable water thoroughly.
7.4.3. Scrub the pallet with 2% approved non-ionic detergent solution using nylon scrubber
7.4.4. After all stains are removed, clean the pallet with 25 litres of running potable water.
7.4.5. Finally rinse the pellet with 30 litres of purified water.
7.4.6. Keep the pallet in slanting position in clean room till dry.
7.5. Material transfer pipe:7.5.1. Transfer the material transfer pipe to the washroom.
7.5.2. Wash each material transfer pipe with 20 litres of running potable water.
7.5.3. Clean the material transfer pipe with 1 litre of 2% non-ionic detergent solution with brush.
7.5.4. Remove the detergent solution with 25 litres of running potable water.
7.5.5. Finally rinse the material transfer pipe with 30 litres purified water.
7.5.6. Intimate QA to collect wash water sample of material transfer pipe.
7.5.7. Dry the material transfer pipe with air blower.
Note: The cleaning of the equipments remains valid for 48 hours. If the equipment is not used within 48 hours then it should be re cleaned as per cleaning procedure for product changeover.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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