07 Cleaning of Empty Capsule Loader 07

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QUALITY NEXGEN PHARMACEUTICAL

Page 1 of 2
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/CL-07
PROCEDURE FOR CLEANING OF Revision No 002
Title
CAPSULE SORTING MACHINE Issue Date 01.03.2016
Department Production Effective Date 01.04.2016
Area Capsule Department Review on or before 01.04.2018
QA & Copy Made: 2 QN/CAP/CL-07
Distribution Supersedes
PRODUCTION
1. OBJECTIVE:

To provide a procedure for cleaning of Empty Capsule Loader.

2. SCOPE :
Applicable to cleaning of Empty Capsule Loader.

3. MAKE & CAPACITY


Anchor Mark (Single Loader)
Anchor Mark (Double Loader)

4. RESPONSIBILITY
Production Chemist/Production Manager. & Operator

5. PROCEDURE
5.1 Switch “OFF” the mains before starting cleaning process.
5.2 Clean the exterior surface of the equipment with a dry duster.
5.3 Dismantle and clean filling ring plates, loader plates, catch plate, finger plates etc.
5.4 Wash dismantle parts under running water followed with soap solution.
5.5 Rinse with hot water and lastly rinse with D. M. water.
5.6 Allow draining the water and drying in air.
5.7 Clean the dust collecting vacuum bag with soap solution and water respectively.
5.8 Assemble the parts and run the machine for 5 minutes, check for any residues / stains on the
machine.
5.9 Check for the wear & tear of the machine.
5.10 Affix the label “CLEANED”.

PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

SIGNATURE
DATE
DESIGNATION PROD. CHEMIST PROD. MANAGER QA MANAGER PLANT MANAGER
QUALITY NEXGEN PHARMACEUTICAL
Page 2 of 2
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/CL-07
PROCEDURE FOR CLEANING OF Revision No 002
Title
CAPSULE SORTING MACHINE Issue Date 01.03.2016
Department Production Effective Date 01.04.2016
Area Capsule Department Review on or before 01.04.2018
QA & Copy Made: 2 QN/CAP/CL-07
Distribution Supersedes
PRODUCTION
6. RECORDS / SPECIMEN

6.1 Records the results in the

Cleaning Record

7. FREQUENCY
At the time of product change over.

8. REVISION HISTORY
8.1 Revision History Table

SOP Number Effective Date Supersedes Brief description of change


QN/CAP/CL-07 01.04.2016 QN/CAP/CL-07 1] Change in Format.
2] Added History,
Frequency, Records and
Revision History table in
SOP.

PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

SIGNATURE
DATE
DESIGNATION PROD. CHEMIST PROD. MANAGER QA MANAGER PLANT MANAGER

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