OPERATING AND CLEANING OF CAPSULE POLISHING MACHINE

0    OBJECTIVE

 The objective of this document is to provide the procedure for operating and cleaning of capsule polishing Machine.

2.0   SCOPE

        This Standard Operating Procedure is applicable for operating and cleaning of capsule polishing machine.

3.0   RESPONSIBILITY

3.1      All Production Officer / Chemist and operators are responsible to follow this standard operating            Procedure.

3.2      Quality assurance is responsible for the compliance of this standard operating procedure.

3.3      Head Production is responsible for the implementation of this standard operating procedure.

4.0   ACCOUNTIBILITY

                  Head – Production  

5.0 PROCEDURE

• Operating Procedure :
• Check the status label “CLEANED” on Capsules polishing unit.
•  Check and ensure that there is no previous product / batch residue.
• Take the approval for cleanliness from in-process IPQA.
• Check and read the status label of capsules as per respective product batch manufacturing records.
• Take the capsules which are to be polished in polishing room.
• Load the capsules to the capsules polishing unit as per capacity.
• Put the 4-5 polishing paper in capsules polishing unit.
• Switch “ON” the main electric power supply and capsules polishing unit. Continue the capsules polishing unit till oil remove from capsules.
• After 15 minutes switch of the capsules polishing unit. Keep polishing paper  a side and collect the capsules in  plastic poly begs, of each with a well labeled duly filled and signed by competent technical staff.
• Transfer the polished capsules for quarantine area.
• After completion of the process affix the status label “TO BE CLEANED” to the capsules polishing unit dully filled and signed by competent technical staff. 
• Record all the observation in respective log book.

5.2      Cleaning procedure

5.3.1   Affix the status label “UNDER CLEANED” to the capsules inspection machine dully filled and signed by competent technical staff.

5.3.2   Remove the previous product identity from the capsules polishing unit.

5.3.3   Clean capsule polishing unit with dry lint free cloth and moping with 70% IPA solution.

5.3.4   Affix the status label “CLEANED” to the capsules polishing unit dully filled and signed by competent technical staff.

5.3.5   Enter the cleaning record in respective Log Book

6.0       TRAINING

Trainer   : Head – Quality Assurance

Trainees : Production staff, Operator & QA   

7.0       DISTRIBUTION

Master Copy                      :           Quality Assurance

Controlled Copy                :           Production Department

Display Copy                    :           Production Department (If Required)

 8.0      ATTACHMENTS

            Nil

•       REFERENCES          

      In-house

10.0     ABBREVIATION

Abbreviation	Extended Form
EG	Engineering
SOP	Standard Operating Procedure
QA	Quality Assurance
WH	Warehouse
NA	Not Applicable
MB	Microbiology

11.0       REVISION HISTORY OF CHANGE

Sr. No.	Date	Revision Details	Revision No.