ISPE Good Practice Guide: SMEPAC – Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems (Third Edition) cover image

ISPE Good Practice Guide: SMEPAC – Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems (Third Edition)

Published:December 2024

Pages:122

This Guide was originally titled ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment.

As in previous editions, this Guide provides principles and standardized methodologies for evaluating the containment capability of equipment used in the pharmaceutical industry under specific, defined conditions. The methodologies include sampling and analysis for airborne emissions and surface deposition of surrogate material processed within the equipment following defined test protocols. These methodologies reflect pragmatic good industrial/occupational hygiene practice.

The Guide has been revised to include complex equipment systems, such as continuous manufacturing equipment and processes, and additional information on surrogate selection. The analysis and interpretation of data has been expanded, along with new test protocols and updates to existing ones.

This new edition incorporates the lessons learned from numerous containment performance assessments conducted by pharmaceutical industry professionals following the criteria outlined in the Guide. It serves as a tool to be used in conjunction with other industry guides. Intended to have global application, it has been developed to meet the needs of equipment suppliers and users.

This the third edition has a new title that reflects what the industry has long referred to as ISPE’s “SMEPAC” Guide.

  • 1 Introduction
  • 1.1 Background
  • 1.2 Purpose
  • 1.3 Scope
  • 1.4 Rationale for the Third Edition
  • 1.5 Benefits
  • 1.6 Structure of This Guide
  • 1.7 Key Concepts and Terms
  • 2 Test Environment
  • 2.1 General Aspects of the Test Environment
  • 3 Test Material
  • 3.1 Introduction
  • 3.2 Selection of Test Material
  • 3.3 Storage of Test Material
  • 3.4 Handling of Test Material
  • 3.5 Surrogate Descriptions
  • 4 Measurement of Airborne Particulate Matter and Surface Contamination
  • 4.1 Introduction
  • 4.2 Airborne Particulate Matter Sampling
  • 4.3 Surface Sampling
  • 4.4 Sampling Strategy
  • 4.5 Task Analysis of Most Probable Emission Points
  • 4.6 Test Cycles/Runs
  • 4.7 Recording Field Data
  • 5 Sampling Strategy
  • 5.1 General Principles
  • 6 Sample Analysis
  • 6.1 Introduction
  • 6.2 Components of a Robust Sampling and Analytical Method
  • 6.3 Laboratory Selection
  • 7 Analysis, Interpretation, and Documentation of Data
  • 7.1 Background
  • 7.2 Establishing a Containment Performance Target
  • 7.3 Comparing Air Sampling Results to the CPT
  • 7.4 Analyzing Surface Sampling Results
  • 7.5 Comparing Surrogate to API
  • 7.6 How to Handle a Failed CPA
  • 7.7 Retesting Equipment
  • 8 Report Writing
  • 9 Appendix 1 – Calculating the Air Change Rate
  • 10 Appendix 2 – Calculating the Required Sensitivity for an Analytical Method and the Minimum Sample Volume
  • 10.1 Sensitivity
  • 10.2 Minimum Sample Volume
  • 11 Appendix 3 – Procedures and Examples
  • 11.1 Swab and Wipe Surface Sampling Procedures
  • 11.2 Inhalable (IOM and DIS) Air Sampling and Analysis Extraction Procedures
  • 11.3 Closed-Face Cassette (CFC) Air Sampling Procedure
  • 11.4 Calculation of Airborne Concentration
  • 11.5 Example Surrogate Material Certificate of Analysis
  • 11.6 Sample Field Data Sheet
  • 11.7 Occupational Hygiene Sampling Checklist
  • 12 Appendix 4 – Containment Equipment Test Protocols
  • 12.1 Protocol 1 – Generic Protocol
  • 12.2 Protocol 2 – Single-Point Transfer System
  • 12.3 Protocol 3 – Downflow Booth
  • 12.4 Protocol 4 – Ventilated Enclosure with Downward Airflow, Air Curtain, and Containment Shield
  • 12.5 Protocol 5 – Unidirectional Airflow Booth
  • 12.6 Protocol 6 – Ventilated Enclosure
  • 12.7 Protocol 7 – Isolator/Glove Box
  • 12.8 Protocol 8 – Flexible-Film Enclosure
  • 13 Appendix 5 – Example Sampling Strategy
  • 14 Appendix 6 – References
  • 15 Appendix 7 – Glossary
  • 15.1 Acronyms and Abbreviations
  • 15.2 Definitions
  • Birger Bockius, Merck Electronics KGaA, Germany
  • Malcolm Cunningham, Chargepoint Technology, United Kingdom
  • Dr. Andreas Flückiger, Andreas Flückiger Consulting, Switzerland
  • Oliver Gottlieb, NNE & PharmaCon Service, Denmark
  • Dr. Michele Grassi, Techniconsult Group SB, Italy
  • Daisuke Hirasawa, Chugai Pharma Manufacturing Co. Ltd., Japan
  • Peter Marshall, CEng, MIChemE, AstraZeneca (retired), United Kingdom
  • Matthew J. Meiners, CIH, SafeBridge Consultants, Inc., USA
  • Rainer Nicolai, PhD (Co-Lead), F. Hoffmann-La Roche AG, Switzerland
  • George S. Petroka (Co-Lead), IES Engineers, USA
  • Dr. Martin Schöler, Fette Compacting GmbH, Germany
  • Peter Schofield, DEC-USA Inc. & Extract Technology, USA
  • Robert Sussman, PhD, DABT, SafeBridge Consultants, Inc., USA
  • Karen Whitaker, MPH, CIH (Co-Lead), Merck, USA

The second edition of the ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment has been updated (Third Edition) and renamed the ISPE Good Practice Guide: SMEPAC – Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems. This reflects the fact that the acronym “SMEPAC” has been the “unofficial” title of this Guide.

This edition addresses the differences between the containment performance of individual components versus a complex process. It provides updated technical guidance and standardized methodologies for evaluating the particulate containment performance (particulate emissions) of pharmaceutical equipment and systems.

This Guide aims to define current good practices and provides information to help organizations to benchmark their practices and improve them. Specifically, this Guide provides a methodology to derive data associated with handling pharmaceutical ingredients that is useful in the assessment of potential risks.