Good Practice Guide: Containment for Potent Compounds


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Published: December 2022
Pages: 258

There are an increasing number of highly potent compounds handled within the pharmaceutical industry, a trend that has continued for over 20 years to the point where most modern products require some degree of containment or other exposure control to maintain safety.

The ISPE Good Practice Guide: Containment for Potent Compounds covers all aspects of pharmaceutical containment including background to safe working levels and the mechanisms of exposure and how such exposure can be controlled. There are chapters on typically applied approaches used in containing exposure for commonly applied process systems across all elements of pharmaceutical development and manufacturing.

Developed by a multinational team of experts consisting of engineers, toxicologists, hygienists, and analysts from major pharmaceutical companies and suppliers, this Guide aims to consolidate this widely dispersed knowledge base into one document. It describes and discusses the containment methodologies, processes, and technologies commonly used in the pharmaceutical industry when handling potent compounds.

The Guide contains numerous photos on the wide range of technologies presented, such as isolators, process interfaces and transfer ports, air locks, filtration systems, containment performance assessments, and cleaning/waste treatment. Additional topics include GMP aspects, containment systems’ lifecycle, unplanned emission/spillage recovery procedures, and the development of a containment strategy.

Guide Core Team

Glenn F. Lawrence, PE, CPIP
Pharmaceutical Professional
GL Lawrence Consulting
Reinhold Maeck, PhD
Head of Corp EHS Regulatory Intelligence
Boehringer Ingelheim Corporate Center GmbH
Rainer Nicolai
Product Owner Engineering Consulting
F. Hoffmann - La Roche AG
George S. Petroka, CIH, CSP
IES Engineers
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Marc W. Abromovitz, CIH
Head Industrial Hygiene
Novartis Pharmaceuticals
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Dirk Collins
Product Manager
Hermann Waldner GmbH & Co KG
Malcolm Cunningham
Director of Sales
Chargepoint Technology
Richard Denk
Senior Consultant Aseptic Processing & Containment
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David Eherts, PhD, CIH
National Safety Council
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Jeffrey A. Fedor, BSME, MSEM, MSPM
Pharmaceutical Specialist/Project Manager
CRB Consulting Engineers, Inc.
Oliver Gottlieb
Senior Specialist, Process Operations, Active Products
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Reinhard Uwe Hahmann
Managing Director
HET Filter GmbH
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Friederike Hermann
Occupational Hygienist
Lonza AG
Kolja Klein
Lead Engineer
Matthew J. Meiners, CIH
Manager, Technial Services
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Martin Pernau
Compliance & Security
Bayer AG
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Charlyn Reihman, MPH CIH
Principal Occupational Health Consultant
SafeBridge Consultants Inc
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Martin Schoeler
Vice President Technology
Fette Compacting GmbH
Peter Schofield
Technical Sales Engineer
Extract Technology Ltd
Robert Sussman, PhD
Managing Director
SafeBridge Consultants, Inc.