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Technical Report No. 13 (Revised)


Fundamentals of an Environmental
Monitoring Program

Bethesda Towers
4350 East West Highway
Suite 200
Bethesda, MD 20814 USA
Tel: 1 (301) 656-5900
This is a preview of "PDA TR 13-2014". Click here to purchase the full version from the ANSI store.

PDA Fundamentals of an Environmental Monitoring Program Technical Report Team


Authors

Jeanne E. Moldenhauer, Excellent Pharma Jeanne Mateffy, Amgen


Consulting, Inc., (Chair) William R. McCullers, Merck & Co., Inc.
James E. Akers, Ph.D., Akers Kennedy & Associates Jeffrey A. Nakamatsu, Cardinal Health
Dilip R. Ashtekar, Ph.D., Parexel Peter J. Noverini, Azbil BioVigilant, Inc.
Jette Christensen, Novo Nordisk A/S Sean J. O’Brien, AstraZeneca
Anthony M. Cundell, Ph.D., Consultant Dona B. Reber, Pfizer
Phil DeSantis, DeSantis Consulting Associates Miriam S. Rozo, J&J Corporate
Michael B. Dolan, Merck & Co., Inc. Gerry Seixas, AstraZeneca
Robert A. Fry, Baxter Healthcare Corporation George Tin, Allergan, Inc.
Maitry Ganatra, Ph.D., Pall Lifesciences Nancy E. Tomoney, Q Pharma
Jennifer L. Gaudet, Olympus Biotech Frank van der Zanden, Bactimm BV
Josephus M. Jordan, Baxter Healthcare Arthur L. Vellutato Jr., Veltek Associates
Amy Jo Karren, Nelson Laboratories, Inc. Robert B. White, Pharmaceutical Sourcing Group
Pamela Martinez, Sanofi Pasteur Americas ( J&J)

Disclaimer: The task force for this report consisted of members representing global companies to ensure that the
methods, terminology, and practices reflect international and not just U.S., procedures. Technical peer reviews were
completed by prominent environmental monitoring scientists.

The content and views expressed in this technical report are the result of a consensus achieved by the authoring task
force and are not necessarily views of the organizations they represent.
This is a preview of "PDA TR 13-2014". Click here to purchase the full version from the ANSI store.

Fundamentals of an
Environmental Monitoring
Program
Technical Report No. 13 (Revised)

ISBN: 978-0-939459-67-4
© 2014 Parenteral Drug Association, Inc.
All rights reserved.

Bethesda Towers
4350 East West Highway
Suite 200
Bethesda, MD 20814 USA
Tel: 1 (301) 656-5900
Fax: 1 (301) 986-0296
E-mail: info@pda.org
Web site: www.pda.org
This is a preview of "PDA TR 13-2014". Click here to purchase the full version from the ANSI store.

Table of Contents

1.0 INTRODUCTION...................................................1 5.3 Isolation Technology....................................... 21


1.1 Purpose ........................................................... 1 5.4 Water............................................................. 22
1.2 Scope............................................................... 1 5.4.1 Sample Site Selection and
1.2.1 Exclusions................................................. 1 Frequency of Monitoring ......................... 22
1.2.1.1 Bioburden Monitoring........................... 1 5.4.2 Sample Collection and Testing................. 22
1.2.1.2 Other Environmental Control 5.5 Air ���������������������������������������������������������������� 23
Support Activities................................. 1 5.5.1 Nonviable Monitoring ............................. 23
5.5.2 Viable Particulates................................... 24
2.0 GLOSSARY OF TERMS.........................................3 5.5.2.1 Sampling Sites................................... 24
5.5.2.2 Methods............................................. 24
2.1 Acronyms......................................................... 5
5.5.2.3 Equipment.......................................... 24
5.6 Compressed Gas Monitoring.......................... 25
3.0 ENVIRONMENTAL CLASSIFICATIONS:
REGULATORY EXPECTATIONS.............................6 5.7 Surface Monitoring......................................... 25
5.7.1 Test Methods........................................... 25
5.7.1.1 Contact Plates.................................... 25
4.0 ENVIRONMENTAL MONITORING.......................10 5.7.1.2 Flexible Films...................................... 26
4.1 Cleaning and Sanitization or Disinfection........ 10 5.7.1.3 Swabs................................................ 26
4.2 Sample Site Selection.................................... 12 5.7.1.4 Surface Rinse Method........................ 26
4.3 Sampling Frequency....................................... 13 5.8 Personnel........................................................ 26
4.4 Alert and Action Levels.................................. 14 5.8.1 Introduction............................................. 26
4.5 Data Management (Data Collection, 5.8.2 Training and Certification of Personnel
Analysis, Approach, and Interpretation)......... 15 for Aseptic Manufacturing Areas............. 27
4.5.1 Collection................................................. 15 5.8.3 Causes for Requalification or Retraining ... 27
4.5.2 Analysis................................................... 16 5.9 Environmental Monitoring During
4.5.3 Interpretation........................................... 16 Product Sterility Testing................................. 27
4.6 Characterization and Identification of Isolates .. 17
4.7 Investigations and Corrective Actions............ 18 6.0 REFERENCES.......................................................28
4.8 Documentation............................................... 20
7.0 BIBLIOGRAPHY...................................................30
5.0 ENVIRONMENTAL MONITORING BY
APPLICATION.....................................................21
8.0 APPENDIX A: CURRENT GUIDELINES FOR
5.1 Terminal Sterilization...................................... 21 TYPICAL ENVIRONMENTAL MONITORING
5.2 Aseptic Processing......................................... 21 FREQUENCIES AND LEVELS—WATER..............32

FIGURES AND TABLES INDEX

Table 3.0-1 Cleanroom Standards— Table 4.5.4-1 USP Chapter <1116> Suggested
Airborne Particulate Limits........................ 8 Contamination Recovery Rates............ 17
Table 4.6-2 Recommended Scheme for
Table 3.0-2 Environmental Monitoring
Microbial Identification............................ 18
Requirements/Guidance............................. 9
Table 4.7-1 Examples of Investigation Elements
Table 4.2-1 Examples of Sampling Sites.................... 13 for Different Systems............................... 19
This is a preview of "PDA TR 13-2014". Click here to purchase the full version from the ANSI store.

1.0 Introduction

Environmental monitoring is adjunct to a sterility assurance program and is used to evaluate the ef-
fectiveness of microbial controls used in the manufacture of sterile pharmaceutical products.

PDA first published guidance on environmental monitoring in the form of Technical Report No. 13 in
1990, and revised the guidance in 2001. This is the second revision of that guidance.

The task force chose to reference the ISO cleanroom classifications as benchmark recommendations
throughout the Technical Report. However, cleanroom classifications expectations are different per
region. Regulatory and compendial classifications have been identified in Tables 3.0-1 and 3.0-2 for
the United States of America, the European Union, and Japan.

1.1 Purpose
This document was created to aid in the establishment of an environmental control and monitoring
program that is meaningful, manageable, and defendable. This revision updates microbiological and
particulate control concepts and principles as they relate to facilities involved in the manufacture of
sterile pharmaceutical products and other designated controlled environments. It expands on PDA’s
2001 revision of Technical Report No. 13 to reflect substantial changes to regulatory guidelines, inter-
national standards, and scientific advances in environmental monitoring procedures and equipment.

This document should be viewed as technical guidance; it is not intended to establish any voluntary
or mandatory standards.

1.2 Scope
This document serves as a resource on controlled environmental test methods, and although some
nonviable particulate information is included, the report’s primary focus is microbiological control
for sterile product manufacturing.

This document addresses international standards and regulatory guidances, elements of an environ-
mental monitoring program, and environmental monitoring by application. Current guidelines for
typical environmental monitoring frequencies and levels for pharmaceutical water are covered in the
appendix.

1.2.1 Exclusions
1.2.1.1 Bioburden Monitoring
Product or component bioburden monitoring is not considered part of all environmental monitor-
ing programs and is therefore outside of the scope of this technical report. Incubation media, times,
and conditions are also not addressed in this document, as individual monitoring circumstances and
requirements will vary and most regulatory expectations are that the sampling conditions should be
justified and validated.

1.2.1.2 Other Environmental Control Support Activities


In order to ensure a consistently acceptable controlled environment, a comprehensive environmental
control program should be supported by:
• Sound facility design and maintenance
• Established documentation systems
• Validated/qualified sanitization/disinfection procedures
• Reliable process controls

Technical Report No. 13 © 2014 Parenteral Drug Association, Inc. 1

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