PT.

TRIYASA NAGAMAS FARMA

ENGINEERING ASSISTANCE
MANUFACTURING FACILITY

Jl. Rawa Udang 75 Rawa Terate

Jakarta Industrial Estate Pulogadung
Jakarta Timur - Indonesia

CLEAN COMPRESSED AIR SYSTEM

VALIDATION PLAN

Document No : VP-CA
Revision No : 00

Prepared by:

Sandipura Building, Fl. 3rd, Room 304

Jl. KH. Abdullah Syafei No.19
Jakarta Selatan, 12840
Indonesia
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TABLE OF CONTENTS
2.1Background......................................................................................................................................................... 7
2.2Description of Current Compressed Air System.............................................................................................. 8
2.3Objectives............................................................................................................................................................ 9
2.4Scope................................................................................................................................................................... 9
2.5Approach/ Rationale......................................................................................................................................... 10
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1. Approval Signature

Prepared by

Name / Designation Signature Date

Mawanti Tambunan/
PT. Asia Pacific Consultants

Reviewed by

Name / Designation Signature Date

Enung Rohayati /
Validation Manager
Dwi Susilohadi /
M&E Manager
M. Parwoko /
Hormone Production Manager
Syanti P. Dewi /
QC Manager
Marthaningtyas D.S /
QA Manager

Approved by

Name / Designation Signature Date

Sri Agung S./

PMC Manager

Ridwan Halim /
Plant Manager

Sorta Saulina /
QAC Manager
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1.
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2. Document History

Revision Date Reason for Revision

00 New Document
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3. References

Code Title

External Reference

BPOM (Badan Pengawas

Obat dan Makanan, Republik Petunjuk teknis; Sarana Penunjang Kritis Industri Farmasi, 2013
Indonesia)

Baseline® Pharmaceutical Engineering Guide for New & Renovated

ISPE
Facilities, Volume 23, Sterile Manufacturing Facilities, 2 nd Edition, 2011

ISPE Good Practice Guide; Process Gases, July 2011

ISO 8573-1 Compressed Air – Part 1: Contamination and Purity Classes, 2010

Internal Reference

VMP Validation Master Plan, Doc. No. VMP752745001, Rev.4

Schematic Drawing Piping System of Compress Air, Doc. No. PL001/00/06

Schematic Drawing
Rev. 5.1
2.
4. Introduction
2.1 Background
PT. Triyasa Nagamas Farma (TNF) has been recognized internationally as a contraceptive as well as OTC and
general health manufacturer. TNF is located on Pulogadung Industrial Estate, Jakarta, Indonesia.
TNF was founded on February 11 th, 1998 and initially produced only contraceptive products to support the
National Family Planning Program. Over subsequent years, TNF has strived to further improve the quality of
their products by optimizing their process technologies while adhering to the standards set by Indonesian
National Agency of Drug Control and Food Control (BPOM). TNF is licensed by BPOM and upholds the
principles determined by the code of Good Manufacturing Practice to ensure that quality is built into the
manufacturing processes, providing end users with safe effective products.
The range of products offered by TNF includes injections, tablets, implants, OTC and other products.
TNF intends that the Facility will be fully compliant with the relevant codes of Good Manufacturing Practice
(GMP) and intends to gain formal licensing by the World Health Organisation (WHO) in order to export their
injectable products.
During late 2012 an audit of the current facility was conducted by Concept Foundation as part of the plan to
obtain WHO Prequalification(s) to enable TNF to export their injectable products.
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Along with a number of other critical systems described in other separate Validation Plans, TNF intends to
concurrently validate the Clean Compressed Air Systems serving the whole Facility. This document is intended
to describe the validation approach to be applied.

2.2 Description of Current Compressed Air System

The Compressed Air plant is located on the west side of the production area within the Utility Area together with
the Pure Steam plant.
TNF has two (2) Compressors to serve the whole Facility which includes Aseptic Production Facility I &II,
Hormone Tablet Production, Hormone Implants Production, Non Hormones Tablet Production, Liquid
Production, Sampling & Weighing Area, Packaging Area and ETO Sterilization areas. Both of the compressors
are screw types manufactured by ‘Kaeser’ each of different capacity.
One compressor is ‘Kaeser type CS 91’ with a working pressure of 7.5 bar. The second compressor is ‘Kaeser
type CSD 122’ with a working pressure of 8.0 bar.
The Compressed Air system is generally comprised of a screw compressor, pressure tank, water separator,
particle filter, oil filter, desiccant dryer and carbon filter.
The following provides a brief description of the compressed air system currently serving the whole
Facility.
From the two compressors the air is supplied into one pressure tank then into the water separator. The water
separator has a maximum capacity 30m3/min. The air is then filtered by a particle filter type ‘FB138’ with a
capacity of 9.4L and 16 bar pressure with an EB type filter. From the particle filter, the air passes into an oil filter
type ‘FE138’ with micro-filter separating oil aerosols and solid particles. The oil aerosol filtered content is less
than 0.01mg/m3. Automatic drainage is installed within the water separator, filter particle and oil filter. The
maximum capacity for automatic drain in the water separator is 30 m 3/min, whilst for particle and oil filter the
capacity is is 4m3/min.
Air is then passed through a desiccant dryer ‘Kaeser DC133’ and dryer ‘Atlas Copco CD180’. The Kaeser dryer
DC133 has a minimum working pressure for 5 bar and maximum of 16 bar. The air is filtered again through a
‘FD138’ particle filter and an oil filter type ‘FE138’. Prior to distribution into the Facility, the air is passed through
two (2) ‘FG138’carbon filters. These carbon filters achieve oil vapor contents of less than 0.003mg/m 3, retain
particles of >0.01µm, and are yield compressed air that is sterile, odorless and tasteless.
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Air that makes contact with product may be drawn only from “Clean Compressed Air Use Points” supplied with
compressed air which is further filtered through the clean compressed air filtration assembly. A 0.2µm filters are
used for sterile use points and 0.45µm or 1µm or better for oral solid dosage delivered via a SS316L housing.
2.3 Objectives
The objective of this Validation Plan is to describe the approach and provide high level guidance to the validation
activities related to the Clean Compressed Air system. This Validation Plan will ensure the validation activities
are arranged to provide documented evidence that the compressed air systems and components can be
expected to continue to function within the specified limits, meeting the predefined system requirements as
appropriate for cGMP-regulated processes..
It is intended to be a working document and will be periodically updated by site management responsible for
project completion and validation.
2.4 Scope
The scope of this Validation Plan (VP) includes qualification of the aspects of the Clean Compressed air systems
serving the Facility that have the potential to affect product quality.
The qualification activities and associated documents for the Compressed Air systems shall include the
following:

 Requirements Specification
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 Validation Plan

 Impact Assessment

 Installation Qualification

 Operational Qualification

 Performance Qualification
Since the system is pre-existing there will be no Design Qualification phase.

2.5 Approach/ Rationale

Through many years of use, the system has been able to function to meet requirements. The system has not
been qualified before, hence the need to upgrade the level of compliance. Qualification activities for the Clean
Compressed Air will adopt a concurrent approach. The validation approach shall be fundamentally based upon
establishing that the system has been installed and operated to the original intent and in accordance with
applicable standards. The validation work shall also establish the qualified system state to enable on-going
change control.
The qualification boundary is subject to user point which is directly affect product quality. The validation works
for the Clean Compressed Air shall be referred to as ‘Qualification’ of the Clean Compressed Air system and
will include the following sequence of activities and documentation.

2.5.1 Requirement Specification

The Requirement Specification (RS) was prepared by extracting the relevant system design, operating and
performance criteria from the drawings and other references detailed in section 3 of this Validation Plan. The RS
will specify the acceptance limits against which the Compressed Air System needs to operate. The RS will
provide a reference for the acceptance limits against which the Compressed Air System needs to operate and
perform in OQ and PQ.
The RS was prepared by PT. APC and reviewed and approved by relevant TNF personnel, including Quality
Assurance.
Any significant change in the documented requirements after the commencement of this validation process shall
be incorporated using version control and shall be reviewed and approved by TNF.
In general, the RS describes:
A brief revision history, background, scope and references.
Details of document author and approver(s).
The system key components and applicable materials of construction.
The system operating and performance requirements.
Any relevant attachments for information.
It is intended that the RS will be the main input document to this validation project.
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2.5.2 Impact Assessment

2.5.2.1 System Impact Assessment (SIA)

The System Impact Assessment (SIA) process documented in section 8 will be adopted to determine which
aspects of the Compressed Air System have the potential to directly or indirectly affect product quality.
Systems having a direct impact will form part of the scope of the qualification activities. Where there is indirect or
no Impact, a Good Engineering Practice (GEP) approach will be used.

2.5.2.2 Component Impact Analysis (CIA)

The CIA is a separate document detailing analysis performed prior to drafting the IQ protocol and used to guide
its creation. All components will be listed and assessed to identify which components having the potential for
critical impact upon product quality. This assessment will define the extent of testing required for individual
system components. Components having a direct impact will form part of the scope of the qualification activities.
Where there is indirect or no Impact, a Good Engineering Practice (GEP) approach will be used.

2.5.3 Installation Qualification (IQ) Protocol & Report

An IQ protocol shall be prepared for the Compressed Air system. As the system is already in use the IQ shall
serve to provide a controlled record of the current state of the system against which any future change control
can be conducted. The IQ protocol will provide documented evidence that critical system components have been
installed correctly and in accordance with the requirements of the manufacturer and the relevant design
documentation.
The IQ protocol shall be prepared by PT. APC, subject to review, pre-approval and execution by relevant TNF
personnel, including Quality Assurance.
In general, this IQ shall comprise (but not be limited to):
 A brief revision history, background, objective and references.
 Details of document author and approver(s).
 Specific instructions on how to execute the IQ.
 Statements regarding what the acceptance criteria for the installation (these are typically that the
installation is in accordance with the specification and drawings or where there is no predetermined
requirement a record of what is installed is provided).
 Lists of checks, and should include as a minimum:
 Reiterate the requirement being checked
 Describe the means of testing the requirement
 Provide space for the reviewers to record whether the installation meets the acceptance criteria
 Allow opportunities to record and attach any relevant appendices.
On satisfactory execution of the IQ Protocol, an IQ summary shall be recorded in the last section of protocol,
reviewed and approved by relevant TNF personnel.
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The IQ summary section shall summarize all the testing done and as a minimum, contain the following:
 Testing summary containing a list of all the IQ checks and their respective pass or fail result.
 Details of any deviations from expected results/acceptance criteria (see section Deviation Handling
and Reporting) and any corrective action taken or rationale for acceptance of the deviation.
 Assessment of success of the IQ and the rational for release for subsequent stages of qualification.

2.5.4 Operational Qualification (OQ) Protocol & Report

OQ is a regulated activity that is part of final the qualification activities after Installation Qualification and before
Performance Qualification begins. An OQ protocol shall be prepared for the Clean Compressed Air system.
The OQ protocol shall provide documented evidence that all critical components operate correctly, through all
specification ranges, and in accordance with documented requirements. These requirements shall be generally
derived from the RS document. The scope and extent of testing is determined by Risk Assessment (see section
Impact Assessment).
The OQ protocol shall be prepared by APC and have to be reviewed, approved and executed by relevant TNF
personnel, including Quality Assurance.
OQ protocol execution should follow Installation Qualification. However, some OQ activities may proceed prior to
the completion of IQ provided that there is justification to do so and any risks have been assessed and
documented.
In general this OQ shall comprise (but not be limited to):
 a brief revision history, background, objective and references
 details of document author and approver(s)
 specific instructions on how to execute the OQ
 statements regarding what the acceptance criteria for the operation are (these are typically that the
system operates and performs to meet all the requirements in the requirement specification)
 lists of tests, and should as a minimum:
 reiterate the requirement being tested
 provide space for the reviewers to record whether the system operation meets the acceptance criteria
 Allow opportunities to record and attach any relevant appendices.

2.5.5 Performance Qualification (PQ) Protocol

The final qualification activity, after satisfactory completion of OQ, is Performance Qualification (PQ). PQ shall be
performed by TNF as a final check for assurance that the nominated testing items in the RS can be continuously
met over a defined period.
The PQ protocol shall be prepared by PT. APC and reviewed, approved and executed by TNF.
The Performance Qualification Protocol shall contain (but not be limited to):
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 A brief revision history, background, objective and references.

 Details of document author and approver(s).
 Specific instructions on how to execute the PQ.
 Statements regarding the acceptance criteria for the PQ (these are typically that the system performs
effectively and reproducibly in accordance with requirement specification).
 Lists of checks, and should as a minimum:
 Reiterate the requirement being checked
 Describe the means of testing the requirement
 Provide space for the reviewers to record whether the installation meets the acceptance criteria
 Allow opportunities to record and attach any relevant appendices.

2.5.6 Performance Qualification (PQ) Summary Report

A final qualification summary report shall be prepared by TNF to summarize the qualification activities conducted
and approval that the Compressed Air System is fit for continued use and performing to the required
specifications.
5. Deviation Handling and Reporting
In instances where the result of the testing does not comply with its acceptance criteria, the root cause of the
non-compliance shall be investigated. If the non-compliance can be rectified promptly, the rectification work shall
be carried out and the testing shall be repeated and approved if it meets the original test criteria. Prior to any
rectification work being conducted that would deviate from the original intent, TNF Quality Assurance shall
review and approve the proposed rectification work. In the document, the results of the original testing, details of
the rectification work and results of the repeated testing shall be recorded.
If a deviation is reviewed and deemed to have no impact, it may be accepted. Any accepted deviations shall be
fully documented and provide justification showing why the non-conformance will have no impact. All accepted
deviations shall be approved by relevant TNF personnel and Quality Assurance.
All deviations will be documented as per SOP Pengendalian Produk Tidak sesuai (Doc. No. PB8307101, Rev
18).

6. Change Control
Change control process must be applied for any modifications following the date of execution of the IQ protocol.
The IQ execution process can capture under deviation some minor last minute changes after protocol drafting
and prior to execution, but once executed the system must be locked, protecting it from uncontrolled changes.
As the system is a pre-existing system, change control is expected to already be in place and operating
effectively.
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7. Responsibility

Responsibility Role
Protocol & Report Developer Validation Staff
Validation Manager, M&E Manager, Hormone Production
Review Protocol & Report Manager, Non-Hormone Production Manager, QA Manager, QC
Manager

Approve Protocol & Report PMC Manager, Plant Manager, QAC Manager

Validation Staff, Engineering Technician, QA Staff, Production

Protocol Executor
Staff
Deviation Reporting & Handling All related department (coordinated by QA Manager)

3.
8. Compressed Air System Impact Assessment
The system impact assessment shall be determined by reviewing the following:
1. Does the system, equipment, or utility come in direct contact with the product? (e.g. air quality).
2. Does the system, equipment, or utility provide an excipient or produce (or have direct contact with)
and ingredient, raw material, or solvent that comes in contact with the process? (e.g. water for injection).
3. Is the system, equipment, or utility used in cleaning/sterilizing/sanitizing? (e.g. clean steam).
4. Does the system, equipment, or utility preserve product status such as product safety, identity,
strength, purity or quality? (e.g. Nitrogen).
5. Does the system, equipment, or utility produce data used to accept or reject product? (e.g. Electronic
batch record system, critical process parameter chart recorder).
6. Is the system a process control system (e.g. PLC, DCS)? That affects a product’s safety, identity,
strength, purity or quality without a system in place for independent verification of control system
performance in place?
If the answer is “YES” for any of the questions above (1-6), then the system should be classified as Direct
Impact. Questions 7-9 will be N/A.
If the answer to ALL of the above questions (1-6) is “No”, proceed to questions 7-9.
7. Does the system, equipment or utility supply a utility or function to a direct impact system?
8. Can the system, equipment or utility affect the performance of a direct impact system?
9. Does the system, equipment, or utility provide information that is used for a regulatory submission (or
in technical report that support the submission), with the exception of registration stability?
If the answer is ‘YES’ to any questions 7-9, then the system should be classified as Indirect Impact.
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If the answer is ‘NO’ to all questions 1-9, then the system should be classified as No Impact.

Legend:
Y = Yes DQ = Design Qualification
N = No IQ = Installation Qualification
N/A = Not Applicable OQ = Operational Qualification
GEP = Good Engineering Practice PQ = Performance Qualification
Note:
The compressed air system is subject to indirect impact system that could potentially have an impact on direct impact
system (Clean compressed air system) but not directly to product quality, hence the complete qualification is not
appropriate.

9. Validation Sequence
No. Qualification Phase Sequence I II III IV V VI VII
Protocol Preparation & Approval
1 IQ Execution
Report Preparation & Approval
Protocol Preparation & Approval
2 OQ Execution
Report Preparation & Approval
3 PQ Protocol Preparation & Approval
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Execution
Report Preparation & Approval