1.0 Objective: To lay down a procedure for the cleaning of SS / HDPE containers, Inprocess containers (IPCs), Blender Bins, pallets, new sieve/screen, and accessories.
2.0 Scope: This procedure is applicable for cleaning SS / HDPE containers, Inprocess containers (IPCs), Blender Bins, pallets, SS items, new sieve/screens, and accessories in the production department.
3.0 Responsibility:
Operator, Officer, Executive – Production Department
Manager – Production Department
4.0 Definitions:
Accessories: Includes spoons, spatulas, paddle, scoop, ladder, table, chairs, and measuring jars which are used on the production floor.
5.0 Procedure:
5.1 Inprocess Containers (IPCs) and Blender Bins:
5.1.1 Ensure that no material is present in the IPC/Blender Bin and duly filled and signed ‘TO BE CLEANED’ label is affixed.
5.1.2 Transfer the IPC and Blender Bin containers to the wash area in Granulation.
5.1.3 Remove the “TO BE CLEANED” status label.
5.1.4 Open the bolts of the butterfly valve and detach it from the IPC/Blender Bin.
5.1.5 Scrub to clean the inside, and outside surface area, lid, and butterfly valve of the IPC/Blender Bin containers using 20-30 liters of P.W. Use the CIP unit if required.
5.1.6 Scrub the PU wheels with a nylon brush and wash with purified water.
5.1.7 Dry it with a dry lint-free cloth.
5.1.8 Wipe the trolley and wheels with a wet lint-free duster.
5.1.9 Reassemble the butterfly valve.
5.1.10 Affix the ‘CLEANED’ label duly filled and signed.
5.1.11 Transfer the IPC/Blender Bin to the day store area.
5.1.12 If the IPC is idle for more than 48 hours, then Clean the IPC/Blender Bin before use. Replace the ‘CLEANED’ label with the ‘TO BE CLEANED’ label.
5.1.13 Re-clean with a dry lint-free duster and wipe with 70% v/v IPA before use.
5.1.14 Replace the ‘TO BE CLEANED’ status label with the ‘CLEANED’ status label.
5.2 S.S. / HDPE containers, utensils, cages, and accessories:
5.2.1 Ensure that no material is present in the container or utensil to be cleaned.
5.2.2 Take the SS / HDPE containers, utensils, cages, and accessories into the Washing area.
5.2.3 Scrub the inside, outside surface, and lid of the container/utensil using a nylon scrubber with 15 – 20 liters of purified water.
5.2.4 Dry the container with the help of a dry lint-free duster.
5.2.5 Transfer the container/utensil to the cleaned vessel storage area.
5.2.6 All S.S. cages are to be cleaned with a wet lint-free duster and dry with the help of a dry lint-free duster.
5.3 S.S. Pallet:
5.3.1 Dry-clean the SS pallet using a dry duster and nylon brush.
5.3.2 During product changeover, clean the SS pallet and PVC pallets with purified water and dry them with a clean lint-free duster.
5.4 Sieve / Screen:
5.4.1 Take the new sieve/screen to the washing area.
5.4.2 Scrub the inside, and outside surface using a nylon scrubber. Clean with 15-20 liters of purified water. Use the CIP unit, if required.
5.4.3 Dry the container with the help of a dry lint-free duster.
5.4.4 Keep sieve/screen individually in the polybag and affix the “CLEANED” label duly filled and signed to individual Sieves/ Screens.
Note: 1. Above procedure is applicable for type B cleaning (to be followed at the time of the product to product change over).
2. Clean the outer and inner surface of the IPCs, HDPE / SS containers, utensils, accessories, cages, and SS pallets, etc. with a dry lint-free cloth during batch changeover (Type A) cleaning.
3. If the same product is run for three days, then follow the cleaning procedure for
type B.
Related SOP: SOP on Cleaning and Sanitization in Pharmaceutical
6.0 Abbreviations:
HDPE: High-Density Polyethylene
IPA: Iso Propyl alcohol
IPC : Inprocess control.
PVC: Poly Vinyl Chloride
SS: Stainless Steel
CIP: Cleaning in Place
7.0 References:
NA
8.0 Annexures:
Nil
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