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Isolation Technology
A Practical Guide
Second Edition
 Isolation Technology
A Practical Guide
Second Edition

Tim Coles

CRC PR E S S
Boca Raton London New York Washington, D.C.


 Library of Congress Cataloging-in-Publication Data

‘Catalog record is available from the Library of Congress.

This book contains information obtained from authentic and highly regarded sources. Reprinted material
is quoted with permission, and sources are indicated. A wide variety of references are listed. Reasonable
efforts have been made to publish reliable data and information, but the author and the publisher cannot
assume responsibility for the validity of all materials or for the consequences of their use.

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No claim to original U.S. Government works

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Library of Congress Card Number XX-XXXXX
Printed in the United States of America 1 2 3 4 5 6 7 8 9 0
Printed on acid-free paper


 Preface to Second Edition
It is now some five years since the first edition of this book appeared. There
have been some technological advances in this time, but perhaps the most
significant changes have been in the acceptance and the understanding of
isolation technology. This acceptance may best be demonstrated by the series
of monographs, guidelines, and standards produced by various bodies,
designed to describe best practice in the design and operation of isolators.
These include:

• Isolators Used for Aseptic Processing and Sterility Testing, Pharma-

ceutical Inspection Cooperation Scheme (Europe)
• Design and Validation of Isolator Systems for the Manufacturing and
Testing of Healthcare Products, Parenteral Drug Association (USA)
• Sterile Drug Products Produced by Aseptic Processing, Food and
Drug Administration (USA)
• ISO EN 14644 Part 7, Separative Devices
• Isolators for Pharmaceutical Applications, 3rd Edition, UK Pharma-
ceutical Isolator Group
• Handling Cytotoxic Drugs in Isolators in NHS Pharmacies, HSE and
MHRA (UK)
• Recommendations for the Production, Control and Use of Biological
Indicators for Sporicidal Gassing of Surfaces within Separative En-
closures, PDA Committee (USA and UK)

This second edition includes descriptions of and comments on these new

documents. Recent technology € such as the new breed of sanitising gas
generators € has been brought into the appropriate chapters, and the text
has been updated throughout to reflect more recent thinking. Finally, minor
errors in the previous edition have been corrected.
The second edition draws heavily on the content of the guideline booklet,
Isolator for Pharmaceutical Applications — 3rd Edition, for both information and
inspiration. I was closely involved in the assembly and editing of this recent
work and make no apology for trawling its content. I am, however, grateful
to my co-editors and to the UK Pharmaceutical Isolator Group for allowing
me this privilege.

© 2004 by CRC Press LLC


 Thanks are also due to GRC Consultants; Malcolm Hughes, Dabur
Oncology; Ray Collyer, Dabur Oncology; James Drinkwater, BioQuell Ltd.;
and Brian Midcalf, UK Pharmaceutical Isolator Group.

Tim Coles
Cambridge

© 2004 by CRC Press LLC

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The Author
Tim Coles holds B.Sc. and M.Phil. degrees in environmental sciences and
has been active in the field of pharmaceutical isolation technology for the
last 20 years. He has worked with La Calhène SA, Cambridge Isolation
Technology, and MDH (now BioQuell Ltd.), and is currently employed as
an isolator specialist by GRC Consultants, part of the Mott-MacDonald
group. Coles has been active in the UK Pharmaceutical Isolator Group and
is on the editorial committee responsible for producing comprehensive new
guidelines on isolation technology. He is also a member the PDA Biological
Indicator Group and is a frequent speaker at conferences and seminars in
the UK and Europe.

© 2004 by CRC Press LLC

Contents
Chapter one Introduction
The background to isolation technology
Isolation technology — a definition
Isolation technology versus barrier technology
The aim of isolation technology
Improvement in product quality
Reduction in costs
Improvements in safety
Flexibility
Special conditions
Qualification
Aesthetics
Some typical applications of isolation technology
Sterility testing
Aseptic filling
Toxic containment
Hospital pharmacy work
Biomedical isolation
Surgical and other miscellaneous uses of isolation
technology
What isolation technology is not: a panacea

Chapter two An introduction to the technology

The materials
Flexible film plastic
Rigid plastics
PVC
Acrylic
Polypropylene
Polycarbonate
Stainless steel
Mild steel
Air handling in isolators
Filtration
Pressure regimes

© 2004 by CRC Press LLC

 Flow regimes
Turbulent flow
Unidirectional flow
Semiunidirectional flow
Air conditioning
Calculations for isolator air handling systems
Handling the work in isolators
Gloves
Half-suits
Full suits
Robotics and automation

Chapter three A review of transfer methods

Simple doors
Lockchambers
Product passout ports
Waste ports
Rapid transfer ports
Mode of operation
Operational considerations
Occluded surfaces
“Ring of concern”
Interlocking
Engineering
RTP containers
Simple
Gassable
Autoclavable
Partially disposable
Totally disposable
Isolator
Powder transfer
How good is the RTP?
A further type of RTP: the split butterfly port
Direct interface
Dynamic mousehole
Pipe and hose connection
Services

Chapter four Further design considerations

Isolator control systems
Simple, turbulent flow isolators
Double-fan turbulent flow isolators
Simple, unidirectional flow isolators
Recirculating unidirectional isolators
Temperature and relative humidity

© 2004 by CRC Press LLC

 Isolator instrumentation
Pressure
Flow
HEPA filter pressure drop
Temperature and relative humidity
Particle counting
Air sampling
Building interface

Chapter five How to draw up a design specification

User requirement specification (URS)
Design qualification
Standards and guidelines
Workspace ergonomics and handling
Rate of work
Major equipment interface
Positive pressure or negative pressure: the cytotoxic
dilemma
Turbulent airflow or unidirectional downflow
Transfer
The isolator room environment for sterile operations
Control and instrumentation
Sterilisation and decontamination
Standard versus special isolator design

Chapter six Seeing the project through

Liaison with your designer and supplier
Further project development
The project plan
DQ, IQ, OQ, and PQ
DQ — design qualification
IQ — installation qualification
OQ — operational qualification
PQ — performance qualification
Some further points about qualification protocols
Proposals and quotations
Preengineering studies, models, and mockups
Terms, payment structures, and guarantees
The OQ in more detail
HEPA/ULPA filter test
Leak testing
Leak detection methods
Soap test
Gas leak detection tests
DOP smoke tests
Pressure tests
Pressure hold
© 2004 by CRC Press LLC
 Parjo
The oxygen test
Expression of pressure decay test results
Hourly leak rate
Percentage volume loss per hour
Volume loss per second (or per hour)
Single-hole equivalent
Classification by leak rate
Further discussion of leak testing: the distributed leak test
Testing gloves and sleeves
Further leakage considerations
When should leak testing be carried out?
Instrument calibration
Airflow patterns
Miscellaneous checks
Particle counting
CIP drainage and drying
Alarms
Breach velocity
Interlocks
Any other relevant parameters
Manuals

Chapter seven Cleaning up: sterilisation and decontamination

Sterilisation — manual wet processes
Fogging processes
Formaldehyde
PAA and other agents
Gassing systems
Recent developments in gas-phase sterilisation
La Calhène SA Sterivap®
Astec Microflow Citomat
Steris VHP 1000™
BioQuell Clarus™
HPV as a sterilising agent
Other gas-phase sterilising agents
Ozone
Ultraviolet light
Validating the sterilisation process
CIP in isolators
Decontamination in toxic and pathogenic applications
Chemical decontamination: cytotoxics
Chemical decontamination: unknown hazards
Biological decontamination: pathogens and recombinant
DNA

© 2004 by CRC Press LLC

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Chapter eight Running the operation
Operator training
Physical validation
Ergonomics and safety
CIP functional test
Particle counting during media filling trials
Stability of the isolator parameters during production
Alarm function
Mechanical and electronic reliability (GAMP)
Microbiological validation
The cleaning process
The sterilisation process
Toxic decontamination
Media fill trials
Viable particle counting during production
Miscellaneous checks
Standard operating procedures
Planned maintenance and servicing
Documentation
Conclusion

Chapter nine Regulatory affairs

The MHRA (formerly the MCA)
The practical considerations
The U.S. FDA view
Further regulatory comment
Standards and guidelines for isolators

Chapter ten Case studies

Aventis (previously Rhone-Poulenc Rorer), Holmes Chapel,
Cheshire, UK
Background
Design and engineering
Validation
Conclusions
Dabur Oncology, Bordon, Hampshire, UK
Introduction
Positive- or negative-pressure isolators?
General layout and cleanrooms
Filling line design
General isolator design
Specific isolator designs detail
Formulation isolator
Depyrogenation isolator
Mobile isolators
Filling isolator

© 2004 by CRC Press LLC

 Freeze-dryer isolator
Gas generators
Sterility testing
Validation
Review in the light of experience
References
Glossary

© 2004 by CRC Press LLC

References
Advisory Committee on Dangerous Pathogens (ACDP), Guidance on the Use, Test-
ing, and Maintenance of Laboratory and Animal Flexible Film Isolators, pub-
lished by HMSO for the Health and Safety Executive, 1985.
AECP 1062, The Parjo Method of Leak Rate Testing Low Pressure Containers, pub-
lished by the Standards Section, Engineering Directorate, UKAEA (Northern
Division), 1981.
Agalloco, J.P., Isolation technology: A consultant’s perspective, in Isolator Technology,
Wagner, C.M. and Akers, J.E., Eds., Interpharm Press, Buffalo Grove, IL, 1995,
p. 324.
Agalloco, J.P., Microbiological Quality Assurance in Pharmaceutical Isolators, Pro-
ceedings of the Scottish Society for Contamination Control Meeting on Phar-
maceutical Isolators, Birmingham, UK, 1996.
Akers, J.E., Isolator technology: Regulatory issues and performance expectations, in
Isolator Technology, Wagner, C.M. and Akers, J.E., Eds., Interpharm Press, Buf-
falo Grove, IL, 1995, pp. 45–48, 51.
Bill, A., Some Considerations about Aseptic Processing and the Use of Isolators, paper
presented to the Third Isolator Conference of the Isolator User Group, Leeds,
UK, 1996.
BS 5295:1976, Environmental Cleanliness in Enclosed Spaces, British Standards In-
stitution.
BS 5295:1989, Environmental Cleanliness in Enclosed Spaces, British Standards In-
stitution.
BS 5726:1979, Specification for Microbiological Safety Cabinets, British Standards
Institution.
BS EN 1822:2000, High Efficiency Air Filters (HEPA and ULPA).
BS PD 6609:2000, Environmental Cleanliness in Enclosed Spaces — Guide to Test
Methods.
Davenport, S.M. and Melgaard, H.L., Ultraviolet Pass-Through as a Transfer Tech-
nology in Barrier and Isolator Systems, paper presented at the PDA/ISPE
Joint Conference on Advanced Barrier Technology, Atlanta, GA, 1995.
EC Guide to GMP for Medicinal Products, published by HMSO for the MHRA
(“European GMP”), 1992.
EN 12469:2000 E: Biotechnology — Performance Criteria for Microbiological Safety
Cabinets, Brussels.

© 2004 by CRC Press LLC

Farquharson, G.F., British and European experience with isolator technology, in Iso-
lator Technology, Wagner, C.M. and Akers, J.E., Eds., Interpharm Press, Buffalo
Grove, IL, 1995, pp. 79, 91–96.
Farwell, J., J. Hosp. Infection, 27:263–273, 1994.
Frean, J.A., Probable Causes of the Johannesburg Fatalities, Proceedings of the Scot-
tish Society for Contamination Control Meeting on Pharmaceutical Isolators,
Birmingham, UK, 1996.
GAMP, Good Automated Manufacturing Practice: Supplier Guide for Validation of
Automated Systems in Pharmaceutical Manufacture, produced by the GAMP
Forum for the International Society for Pharmaceutical Engineering, 1996.
Health & Safety Executive, Handling Cytotoxic Drugs in Isolators in NHS Pharma-
cies, HSE/MHRA, 2003.
ISO/DIS 14644–7: Cleanrooms and Associated Controlled Environments — Part 7:
Separative Enclosures (clean air hoods, glove boxes, isolators, and minienvi-
ronments), IEST, Geneva, 2000.
Lee, G.M. and Midcalf, B., Eds., Isolators for Pharmaceutical Applications (Yellow Guide),
published by HMSO for the UK Pharmaceutical Isolators Group, 1994.
Lumsden, G., personal communication, 1996.
Lyda, J.C., Regulatory aspects of isolation/barrier technology, in Isolator Technology,
Wagner, C.M. and Akers, J.E., Eds., Interpharm Press, Buffalo Grove, IL, 1995,
p. 67.
MDH Ltd., technical literature, 1995.
Melgaard, H.L., Barrier Isolator Design Considerations for Clean-in-Place, presenta-
tion to the PDA/ISPE Joint Conference on Advanced Barrier Technology,
Atlanta, GA, 1995.
Meyer, D., Developing a barrier/isolator implementation plan, in Isolator Technology,
Wagner, C.M. and Akers, J.E., Eds., Interpharm Press, Buffalo Grove, IL, 1995,
p. 116.
Michael, D., International Standards — Current Developments, paper presented to
the Third Isolator Conference of the Isolator User Group, Leeds, UK, 1996.
Midcalf, B.M., Phillips, W.M., Neiger, J.S., and Coles, T.P., Eds., Pharmaceutical Isolator
Working Party, Pharmaceutical Isolators and their Application (3rd edition of the
Yellow Guide), awaiting publication by The Pharmaceutical Press, London,
May 2004.
Muhvich, K., Perspective on Isolator Technology, presented at the Barrier Isolation
Technology Conference, Rockville, MD, 4–6 December, 1995.
Neiger, J., Life with the UK pharmaceutical isolator guidelines: a manufacturer’s
viewpoint, Eur. J. Parenteral Sci., 2(1): 13–20, 1997.
Neiger J.S., Negative Isolation, Cleanroom Technology, April 24–25, 2001.
Ohms, R., Assembly and Filling of Cartridges in an Isolator, Proceedings of the R3
Nordic Meeting, Copenhagen, 1996.
Parks, S.R., Bennett, A.M., Speight, S.E., and Benbough, J.E., An assessment of the
Sartorius MD8 microbiological air sampler, J. Appl. Bacteriol., 80:529–534, 1996.
PDA (U.S. Parenteral Drug Association) Technical Report 34: Design and Validation
of Isolator Systems for the Manufacturing and Testing of Healthcare Products,
Bethesda, MD, 2001.
PDA Biological Indicator Working Group (Europe), Recommendations for Biological
Indicators Used in Development and Qualification of Sporicidal Gassing Pro-
cesses, in preparation, 2004.

© 2004 by CRC Press LLC

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