Compressed Air in Pharmaceutical Industry PDF

GMP – Compressed Air in Pharmaceutical Industry
SWISS GERMAN UNIVERSITY
Compressed Air in
Pharmaceutical Industry
Paulus Gunawan
paulus.gunawan@sgu.ac.id
9-Jan-13 Paulus Gunawan 1

Source of contaminations
• Intake air from surroundings (oil, dirt/dust
and moisture/ water vapour, virus,
bacteria, germ, micro-organisms)
• Compressor unit (note : equipment uses oil for
lubricants) (including Air Receiver + Filters)
• Piping Distribution Systems and Fittings/
Accessories (rust/particles)  ?

Recommended Type
Oil Free Compressed Air :
Air compressed from initial pressure to final
pressure using compressor in which the air is
not in direct contact with any fluid or lubricant
Achieved by using Oil Free Rotary Screw and

Centrifugal Compressors

Up-date Air Quality Classes

• ISO 8573.1 Class 0
• Note : contamination cannot be eliminated
but can be reduced  starting from the
source and by filtration – purification –
separation through various equipment,
media filter



Parameters to be checked based on

PIC Utility Inspection /

Compressed Air in Pharmaceutical

Facility
• Operation of Equipment (pneumatic
system) Packing Equipment : Blister
Pack Machine, Powder Filling Machine etc.
• Vacuum cleaning system
• Spray system (coating, mixing and FBD)
• Others / Innovation : Tablet Press Machine,
Capsule Filling Machine, Drying Container

Air Quality Testing

• During Performance Qualification (PQ)
• Check and Testing against major critical
parameters (key design criteria)
 Solid / Particle / Dust : Particle Counter Measuring
Equipment  example Met One Particle Counter
 Liquid / Vapor / Moisture : PDP (pressure dew point)
 hygrometer
 Oil content : Oil measuring kits from Drager
 Microba / Viable Organism testing (Slit to Agar) 
Air Sampler (Biotest diagnostic air sampler)

FUNCTION Compressed Air in

Pharmaceutical Production Use
Compressed Air Generation (Air
Compressor) and Distribution Piping
System should be suitable for production of
dry and oil-free compressed air, continuous
distribution of Compressed Air in sufficient
quantity and quality to the points of use
(POU)/ user point.

COMPRESSED AIR QUALITY

• The compressed air quality must comply
with the relevant ISO 8573-1 standard,
quality class 1 for particles and oil residues
(aerosol, liquid, and vapour), quality class 2
for humidity & liquid water (class 1.2.1)
• Quality requirements should be updated and
revised if quality requirements are requested
to higher standards.
ß The Compressed Air Generation and

Distribution/ Piping Systems should be
constructed according to GMP
requirements.
ß Dead legs/zones after sterile filters should
be avoided.

CONSTRUCTION REQUIREMENTS
ß Appropriate materials of manufacture must be

selected and specified in accordance with GMP
regulations depending on the specific application
and process requirements.
ß All materials, instruments and instrument
enclosure materials shall be of durable type.
ß Compressed air contact parts should be made from
FDA accepted materials (food grade standard)

ß Surface finish on compressed air contact

parts should be such that adherence of
particle or liquids is minimized.
ß Join materials, then it should be crevice free
and flush with the adjacent material.
ß The surface finish shall be the same
standard as the adjacent material.

ß Non compressed air contact parts should be

made of FDA accepted materials.
ß The surface finish on non product contact
parts should be such that cleaning of the
surface made easy (easily cleaning)
ß All pipes should be complete drainable and
possible to sanitize

• The piping must be passivated in factory with

adequate passivation solutions and should be
repassivation after completely installed
• Compressed Air Generation and Distribution shall
operate in such a way that the compressed air
produced flows smoothly through the pipe works
to the point of use.
• Stable pressure compressed air at all point of use
(looped system preferable)

CLEANABILITY and IDENTIFICATION

• The outer surface of Compressed Air
Generation and Distribution Piping System
should be easy to clean.
• Identification and flow direction should be
available (marked)

Parameters, Specification and Limits

(URS)
The Items could be slightly different depend
of Users




Other Parameters
EHS Critical Parameters (Engineering
Parameters Not To Be Validated)

Inspection on Compressed Air

• Drawings and installed (reality)
• Maintenance Program
• Change Control

“Check List In logical order “

√Contact with product or with process
equipment
√Type of product – non sterile – terminally
√Name tag/ labelling and identification of
the system
√Connections – risk of mix-up
√Identity all other used gases

“Check List In logical order “

√Changing systems for filters
√SIP systems / CIP
√Back-up systems
√Capacity vs. consumption
√Maintenance program
√Calibration program
√SOP’s
√Records
√Breakdown / emergency including challenges o
alarm systems

Reference :
• PIC/S PI 09-3 Aide Memoire September
2007
• Manufacturer Manual : Atlas Copco and
Ingersoll Rand
• Pharmaceutical Facility Management, JPS
Kohli

Compressed Air in Pharmaceutical Industry PDF

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Compressed Air in Pharmaceutical Industry PDF

Uploaded by

Copyright:

Available Formats

GMP – Compressed Air in Pharmaceutical Industry

SWISS GERMAN UNIVERSITY

9-Jan-13 Paulus Gunawan 1

9-Jan-13 Paulus Gunawan 2

Achieved by using Oil Free Rotary Screw and

9-Jan-13 Paulus Gunawan 3

Up-date Air Quality Classes

9-Jan-13 Paulus Gunawan 4

9-Jan-13 Paulus Gunawan 5

9-Jan-13 Paulus Gunawan 6

Parameters to be checked based on

9-Jan-13 Paulus Gunawan 7

Compressed Air in Pharmaceutical

9-Jan-13 Paulus Gunawan 8

Air Quality Testing

9-Jan-13 Paulus Gunawan 9

FUNCTION Compressed Air in

9-Jan-13 Paulus Gunawan 10

COMPRESSED AIR QUALITY

ß The Compressed Air Generation and

9-Jan-13 Paulus Gunawan 12

ß Appropriate materials of manufacture must be

9-Jan-13 Paulus Gunawan 13

ß Surface finish on compressed air contact

9-Jan-13 Paulus Gunawan 14

ß Non compressed air contact parts should be

9-Jan-13 Paulus Gunawan 15

• The piping must be passivated in factory with

9-Jan-13 Paulus Gunawan 16

CLEANABILITY and IDENTIFICATION

9-Jan-13 Paulus Gunawan 17

Parameters, Specification and Limits

9-Jan-13 Paulus Gunawan 18

9-Jan-13 Paulus Gunawan 19

9-Jan-13 Paulus Gunawan 20

9-Jan-13 Paulus Gunawan 21

9-Jan-13 Paulus Gunawan 22

Inspection on Compressed Air

9-Jan-13 Paulus Gunawan 23

“Check List In logical order “

9-Jan-13 Paulus Gunawan 24

“Check List In logical order “

9-Jan-13 Paulus Gunawan 25

9-Jan-13 Paulus Gunawan 26

You might also like