SOP for Cleaning Procedure of Blister Pack Machine

OBJECTIVE

To lay down a procedure for cleaning of blister pack machine.

SCOPE

This procedure applies to the packing department in the Pharmaceutical Manufacturing Facilities of PharmaInfo Limited. This procedure covers the cleaning of the blister pack machine.

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

Routine cleaning procedure (Batch to Batch)

1. At the end of the day, the dust collecting tray under the vibrator bowl should be removed and the dust emptied out. The tray should be replaced in its position.
2. Using a Vacuum Cleaner, the machine body and hopper should be cleaned.
3. The chute should be dismantled and wiped with Acetone.
4. Wipe out the machine body with clean clothes.
5. Clean the floor, walls, and glass of the Department with soap and water.
6. Fix the “IN-PROCESS” tag which indicates the product Name and Batch No.

ALSO READ: SOP for Operation & Cleaning of Strip Packing Machine

Product changeover procedure

1. Remove the PVC and Glassine Foil and it should be reconciled with the batch
2. Remove the hopper, Bowl, chute, and rack, and clean it with liquid soap and Purified water.
3. Remove the powder from the machine body with a Vacuum Cleaner or Hand Blower.
4. Dismantle the Blister-forming roller and counter-sealing roller and clean it with water and dry it.
5. Clean the floor, walls and glass of the Department with soap and water.
6. Fix the status tag indicating “CLEANED” status and dully filled with the date, previous product details, cleaned by, and checked by.

• Note: 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 clean dry duster.
• All the operation 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

ALSO READ: SOP for Reconciliation of Packing Materials