Alembic Limited ,

Page 1 of 7

VALIDATION PROTOCOL
FOR
COMPRESSED AIR

Document No.: ALB/F/CAP/001-00

ALB/QA051/F01-00

Alembic limited
COMPRESSED AIR VALIDATION PROTOCOL
TITLE: Protocol for Validation of Compressed Air
Doc. No.: ALB/F/CAP/001-00

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Approval

Activity
Prepared by

Name

Designation

Amit Kumar Tumbariya

Executive QA

Arun Kakadia
Reviewed by

Executive
Microbiology

Kailsh Yadav

Engineering Head

Satish Kukrety

Site Quality Head

Devendra Vijay

GM Works

Approved by

ALB/QA051/F01-00

Signature / Date

Alembic limited
COMPRESSED AIR VALIDATION PROTOCOL
TITLE: Protocol for Validation of Compressed Air
Doc. No.: ALB/F/CAP/001-00

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Table of Content
Section #
Section 1.0
Section 2.0
Section 3.0
Section 4.0
Section 5.0
Section 6.0
Section 7.0
Section 8.0
Section 9.0
Section 10.0
Section 11.0

Description
Title
Objective
Scope
Responsibilities
Parameters
Sampling Details
Acceptance Criteria
Procedure
Observations
Revalidation Criteria
Summary and Conclusion

ALB/QA051/F01-00

Section 1.0

Title

Section 2.0

Validation Study of Compressed Air.

Alembic limited
COMPRESSED AIR VALIDATION PROTOCOL
TITLE: Protocol for Validation of Compressed Air
Doc. No.: ALB/F/CAP/001-00

Objective

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The objective of this protocol is to establish documented evidences to ensure that

Compressed air used in manufacturing process meets with pre determined
specifications and quality attributes.

Section 3.0

Scope

This protocol is applicable to validate the Compressed air used in manufacturing

process at Alembic Limited, Baddi.

Section 4.0

Responsibilities:
Department
Quality Assurance

Designation
Officer/Executive/Designee

Area of Responsibility
- Preparation & approval of
validation protocol.
- Review of data.
- Compilation of results in the

Quality Control
Engineering

Officer/Executive - Microbiology

report.
- Sampling

Officer/Executive

compressed air
- Coordination for sampling

&

analysis

of

- Review of Validation protocol

ALB/QA051/F01-00

Section 5.0
Parameters

:
:

Following parameters shall be monitored during validation study of Compressed

Air:

(i)

Total Viable Aerobic Count

Alembic limited
COMPRESSED AIR VALIDATION PROTOCOL
TITLE: Protocol for Validation of Compressed Air
Doc. No.: ALB/F/CAP/001-00

Section 6.0

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(ii)

Non viable particulate matter

(iii)

Oil & mist content

Sampling Details

Sampling Point

Sampling Location/Equip. ID No.

Sampling Pressure/Time

CGP1

RMG (Granulation-1) / ALB/PR/TG1004

1 Kg/cm2 for 10 Minutes

CGP2

RMG (Granulation-2) / ALB/PR/TG2004

1 Kg/cm2 for 10 Minutes

CGP3

Autocoater (Coating-1) / ALB/PR/CO1001

1 Kg/cm2 for 10 Minutes

CGP4

Autocoater (Coating-2) / ALB/PR/CO2001

1 Kg/cm2 for 10 Minutes

Section 7.0

Acceptance Criteria :
Parameters
Viable Count
Non viable particulate matter
Oil & mist

Acceptance Criteria
NMT 10 Cfu.
Visually clean & free from particles.
Physically free from oil & mist.

ALB/QA051/F01-00

Section 8.0
Procedure

:
:

Compressed air shall be monitored for defined parameters (section 5.0) for one
week continuously as per sampling details (section 6.0).

Section 9.0

Observations

Alembic limited
COMPRESSED AIR VALIDATION PROTOCOL
TITLE: Protocol for Validation of Compressed Air
Doc. No.: ALB/F/CAP/001-00

Date

Section 10.0

Sampling
Sampling
Point
Location
CGP1
RMG
(Granulation-1)
CGP2
RMG
(Granulation-2)
CGP3
Autocoater
(Coating-1)
CGP4
Autocoater
(Coating-2)

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Viable Count

Non viable
particulate matter

Oil & Mist

content

Revalidation Criteria:
Revalidation is recommended when there is any change in the design, location and major repairs
or maintenance of the compressed air system, which can impact the quality of the compressed
air.

ALB/QA051/F01-00

Section 11.0

Summary and Conclusion :

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Alembic limited
COMPRESSED AIR VALIDATION PROTOCOL
TITLE: Protocol for Validation of Compressed Air
Doc. No.: ALB/F/CAP/001-00

Page no.: Page 7 of 7

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Prepared By:

ALB/QA051/F01-00

Reviewed By: