OBJECTIVE
To lay down a procedure for cleaning of vibro sifter.
SCOPE
This procedure applies to the production department in the Pharmaceutical Manufacturing Facilities of XYZ Limited. This procedure covers the cleaning of vibro sifter.
RESPONSIBILITY
The concerned operator is responsible for the implementation of the process.
The production In-Charge is responsible for the execution and compliance of the procedure.
PROCEDURE
- Brief Description: This 750 mm sifter is a G.M.P model. Make Pharma FAB Industries. All the body, including the motor, is cladded with stainless steel. All the contact parts are made up of Stainless Steel.
- Type “A” Cleaning (Batch to Batch Change over).
- Switch off the electrical mains of the machine.
- Remove all the powder from the machine with a vacuum cleaner.
- Wipe out the machine with a dry lint-free duster.
- Clean the floor with soap water & potable water.
- Fix the ‘under process’ tag, which should indicate the product name and batch number.
- Type “B” Cleaning (Product Change Over)
- Remove all the powder from the machine with a vacuum cleaner/hand blower.
- Loosen the holding clamp & remove the hopper ring, sieve & sieve stand respectively.
- Clean all these parts and the machine body with soap water, and potable water and finally clean with Purified Water BP.
- After cleaning check the integrity of the sieve.
- Clean the floor, walls, and glass partitions of the department with soap water and potable water.
- Fix the ‘CLEANED’ tag duly filled with the date, initial, and previous product details.
- Cover the clean machine with an appropriate cloth body cover.
- If the cleaned machine is not used within 24 hours or there are signs of dust or powder settled on the outside surface then the exterior of the equipment should be wiped with a wet duster followed by a dry duster.
- All the cleaning details shall be entered in the equipment cleaning log.
REFERENCE
SOP: Preparation, Approval and Control of Standard Cleaning Procedures for equipment.
ABBREVIATION
Q.A: Quality Assurance
SOP: Standard Operating Procedure
No.: Number
P.D: Production
ANNEXURE
Nil.
REVISION HISTORY
Nil.
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