Cleaning of Lifting and Positioning in Pharmaceuticals

In this post Standard Operating Procedure of Cleaning of Lifting and Positioning in Pharmaceuticals is describe. 

1.0 OBJECTIVE:  

To lay down a procedure for cleaning of Lifting and Positioning Device for RMG 

2.0 SCOPE: 

This procedure is applicable to cleaning of Lifting and Positioning Device for RMG in granulation area.

3.0 RESPONSIBILITY: 

Production : Technical Associate/ Officer /Executive/Assistant Manager

Head Production: To ensure execution & compliance.

Head QA: To ensure the compliance.

4.0 PROCEDURE

4.1 Cleaning: TYPE A

4.1.1 Change over from one batch to coming batch of the same product with same energy and of analogous product with thrusting energy.

4.1.2 Remove “ TO BE gutted ” marker and fix “ UNDER drawing ” marker to the machine with date and hand of the product officer..

4.1.3 Ensure that the main power supply is switched off.

4.1.4 Clean the lifting arm, body of LPD and control panel by using clean dry lint free cloth.

4.2 TYPE B:

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

4.2.1 Remove “ TO BE gutted ” marker and fix “ UNDER drawing ” marker to the machine with date and hand of the product officer.

4.2.2 Ensure that the main power supply is switched off.

4.2.3 Cover all the electrical parts with polyethylene bag.

4.2.4 Clean the lifting arm, body of LPD and control panel by using clean dry lint free cloth

4.2.5 Clean the lifting arm and body with approx. 30.0 to 40.0 kg purified water

4.2.6 Wipe the body, lifting arm, and control panel with wet duster soaked in purified water.

4.2.7 Dry the entire surface and all parts of LPD with clean dry lint free cloth.

4.2.8 Wipe the LPD as well as all the cleaned parts with the clean dry lint free cloth soaked in 70 % v/v IPA solution.

4.2.9 Remove the “UNDER CLEANING “label and affix “CLEANED” label to the machine.

5.0 ANNEXURE (S):

Nil

6.0 REFERENCE (S):

SOP: Preparation, approval, distribution control, revision and destruction of Standard Operating Procedure (SOP).

SOP: Procedure for area line clearance.

7.0 ABBREVIATION (S) /DEFINITION (S):

IPC : In process Container

Q.A. : Quality Assurance

RMG : Rapid Mixer Granulator

SOP : Standard Operating Procedure

LPD : Lifting and Positioning Device

Kg : Kilogram

v/v : volume/volume

REVISION CARD

 

Sr. No.	Revision No.	Revision Date	Details Of Revision	Reason (S) For Revision	Reference Change Control No.