Cleaning and Operation of Portable Mechanical Stirrer (Make-Remi)

In this post Standard Operating Procedure Cleaning and Operation of Portable Mechanical Stirrer (Make-Remi) in Pharmaceuticals is describe.

1.0 OBJECTIVE:

To lay down a procedure for Cleaning and Operation of Portable Mechanical Stirrer (Make-Remi).

2.0 SCOPE:

This procedure is applicable to the Cleaning and Operation of Portable Mechanical Stirrer (Make- Remi) in Production area.

3.0 RESPONSIBILITY:

Technical Associate: Cleaning and Operation Officer and Executive: Supervision

Head Production: SOP compliance IPQA Person: Line Clearance

4.0 DEFINITION (S):

5.0 PROCEDURE:

5.1 “TYPE A” CLEANING:

Change over from one batch to next batch of the same product and same potency and of similar product with ascending potency.

5.1.1 Replace the ‘UNDER PROCESS’ status label with dully filled and signed ‘TO BE CLEANED’ status label.

5.1.2 Record the cleaning start time in the Equipment usage log sheet as per SOP.

5.1.3 Ensure that the main power supply is turned ‘OFF’.

5.1.4 Remove the speed controller connection.

5.1.5 Wipe the speed controller with a dry lint free cloth and keep it in dry place.

5.1.6 Dismantle the stirrer shaft from the motor and take it to wash area.

5.1.7 Clean the stirrer shaft with purified water and scrub the stirrer shaft with nylon scrubber to remove the adhere material of previous batch.

5.1.8 Finally rinse the stirrer shaft with sufficient quantity of purified water.

5.1.9 Ensure the cleanliness of stirrer shaft and wipe it with dry lint free cloth.

5.1.10 Clean the stirrer body and motor with dry lint free cloth followed by wet lint free duster.

5.1.11 Assemble the stirrer shaft with the motor and connect the speed controller connection.

5.1.12 Replace the ‘TO BE CLEANED’ status label with dully filled and signed ‘UNDER PROCESS’ status label.

5.1.13 Record the cleaning observations in the Equipment usage log sheet as per SOP.

5.1.14 If the TYPE-A cleaned equipment is not used within 12 hours, clean the equipment as per “TYPE-B” cleaning.

5.2 “TYPE B” CLEANING:

This is a cleaning procedure for Changeover of product with different actives / with different color / descending potency or after maintenance of contact parts.

5.2.1 Follow the step 5.1.1 to 5.1.9

5.2.2 Wipe the stirrer shaft with 70% v/v IPA followed by clean dry lint free cloth.

5.2.3 Follow the step 5.1.10 to 5.1.11

5.2.4 Replace the ‘TO BE CLEANED’ status label with “CLEANED” label dully filled and signed ‘by production officer and QA officer.

5.2.5 Record the cleaning start time in the Equipment usage log sheet as per SOP.

5.2.6 After completion of operation, clean the equipment within 24 hours if not in use.

5.3 Frequency:

5.3.1 Type ‘A’ cleaning is applicable after completion of every batch of same product. If same product is processed for more than a week then follow the procedure of type – B cleaning.

5.3.2 Type ‘B’ cleaning is applicable in case of changeover of product with different actives / color / descending potency or after maintenance of contact parts or same product is run for more than seven days cleaning Type - B done after completion of batch.

NOTE: After Type - B cleaning, if machine is not used within 72 hours, clean the machine “before use”, with the lint free duster dipped in 70% v/v IPA solution followed by dry lint free duster and dully sign the “CLEANED” label again. Record the activity in equipment usage log sheet as per SOP.

5.4 OPERATION:

5.4.1 Replace the ‘CLEANED’ status label with dully filled and signed ‘UNDER PROCESS’ status label.

5.4.2 Record the Operation start time in the Equipment usage log sheet as per SOP.

5.4.3 Take the SS bin as per requirement for coating solution / Binder solution.

5.4.4 Take the tare weight of SS bin and keep it under the portable stirrer.

5.4.5 Take the required quantity of purified water and transfer it to SS bin.

5.4.6 Start the stirrer and set the rpm of stirrer from speed controller.

5.4.7 Speed should as such that there should be vortex formation in the purified water.

5.4.8 After vortex formation in water add the coating material / binder slowly.

5.4.9 After addition of material stirring should be continued as per time specified in BMR.

.4.10 After completion of stirring, stop the stirrer and remove the SS bin beneath from portable stirrer.

.4.11 Record the Operation end time in the Equipment usage log sheet as per SOP.