QUALITY NEXGEN PHARMACEUTICAL

Page 1 of 3
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/CL-04
PROCEDURE FOR CLEANING OF Revision No 001
Title CAPSULE INSPECTION CUM
Issue Date 01.03.2016
POLISHING MACHINE
Department Production Effective Date 01.04.2016
Area Capsule Department Review on or before 01.04.2018
QA & Copy Made: 2 QN/CAP/CL-04
Distribution Supersedes
PRODUCTION
1. OBJECTIVE:

To provide guidelines for manually capsule inspection, polishing and effective removal of powder from
surface of the capsule.

2. SCOPE :

The procedure applies to product change over - Capsule inspection & Polishing M/C for product
Change over.

3. MAKE & CAPACITY

Pacific Technologies.

4. RESPONSIBILITY
Production Chemist/Production Manager & Operator

5. PROCEDURE
5.1 Switch off the mains.
5.2 Remove the labels of previous product.
5.3 Remove all the drums of previous product.
5.4 Wipe off dust from the glass pans, lighting & fixtures.
5.5 De– dust external surface of the machine using a nylon brush.
5.6 Dismantle & Clean.

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 3
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/CL-04
PROCEDURE FOR CLEANING OF Revision No 001
Title CAPSULE INSPECTION CUM
Issue Date 01.03.2016
POLISHING MACHINE
Department Production Effective Date 01.04.2016
Area Capsule Department Review on or before 01.04.2018
QA & Copy Made: 2 QN/CAP/CL-04
Distribution Supersedes
PRODUCTION
5.6.1 Hopper: Remove hopper and clean with a dry duster then wash with a suitable detergent
0.1%Teepol solution finally wash thoroughly with D.M water to remove last traces of
detergent. With a lint free duster wipe & dry the hopper.
5.6.2 Conveyor belt: Remove belt dip it in a suitable container containing.1%Teepol solution.
Soak the belt for about 15 minutes. Scrub each plate by a scrubber wash belt thoroughly
finally with sufficient D.M. water. Hang the belt till water drains off. Dry it in drier.
5.6.3 Polishing brushes: Remove the housing of polishing brushes. remove the polishing
towel & the brush. Wash the housings from inside & outside thoroughly if required scrub
with a scrubber. Wash with D.M water & dry the parts in drier. Wash the nylon brushes
with a fast jet of water. or keep it soaked in a container containing detergent rub the
brushes with hand to remove adhering powder. Wash brushes thoroughly under the
stream of D.M water allow the water to drip. Dry brushes in drier.
5.6.4 Polishing Towels: Remove polishing towels from upper & lower polishing channels
wash thoroughly with water & detergent . Squeeze the towels to drain water & dry in the
drier.
5.6.5 SS Housing: Wash SS housing of the polishing brushes from inside & outside by
detergent .finally wash with D.M. water. Wipe with a lint free duster.
5.7 Inform Q.C department to collect wash sample.

6. RECORDS / SPECIMEN
6.1 Records the results in the

Cleaning Record

PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

SIGNATURE
DATE
DESIGNATION PROD. CHEMIST PROD. MANAGER QA MANAGER PLANT MANAGER
 QUALITY NEXGEN PHARMACEUTICAL
Page 3 of 3
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/CL-04
PROCEDURE FOR CLEANING OF Revision No 001
Title CAPSULE INSPECTION CUM
Issue Date 01.03.2016
POLISHING MACHINE
Department Production Effective Date 01.04.2016
Area Capsule Department Review on or before 01.04.2018
QA & Copy Made: 2 QN/CAP/CL-04
Distribution Supersedes
PRODUCTION
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-04 01.04.2016 QN/CAP/CL-04 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