CoP Containment


About

In ISPE D/A/CH, members are actively involved in regional working groups and the CoP’s (Communities of Practice). Through technical/topic-based workshops, discussions, and communication, best practice working papers and approaches are developed in the sensitive environment of patient safety. They serve as guidelines for the industry and the authorities. Members of ISPE D/A/CH participate in the ISPE Guides.

Introduction

The goal of the CoP “Containment is to provide operators, planners, manufacturers as well as interested parties who deal with containment systems in their daily work with a discussion platform for technical topics and for the exchange of experiences. This objective is supported by annual expert discussions on topics in the field of “containment”. In addition, there is a regular exchange of experiences with the CoP’s of other affiliates.

Containment

The topic of containment moves the pharmaceutical industry. Many newly introduced drugs are effective even in small doses – their ingredients are highly active. For patients, this development is an opportunity; for manufacturers, it is a challenge. Low occupational exposure limits and complex toxicological assessments require special measures for process safety in the laboratory and in production.

The new Containment Manual

Now available – the new edition of the successful Containment Handbook of the Working Group.

The German Containment Handbook in the 2nd edition is available as a book.

The manual covers risk assessment, containment life cycle, process requirements, technical systems, validation, cleaning and personnel. Each chapter of the handbook begins with a definition or introduction, concepts, processes, technologies are identified and described in the form of best practices or as illustrated examples. The new EMA guidelines, “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”, are also taken into account.

The working group on Linkedin

The direct contact to the experts on Linkedin:
Richard Denk / SKAN AG
Dr. Reinhold Maeck / Boehringer Ingelheim GmbH
Martin Pernau / Bayer AG
Markus Rückert / PHACOSO Pharma Containment Solution

The Linkedin group will address issues related to the handling of highly potent substances and corresponding containment solutions and will be used there to publish information, events, publications. For special questions, the members of the Steering Committee of the ISPE CoP Group can be consulted.

If interested, visit and on LinkedIn

Chair CoP Containment

Richard Denk
SKAN AG

richard.denk@ispe-dach.org

Steering Committee

Henryk Badack,
Vetter Pharma-Fertigungs GmbH & Co KG

Dirk Collins,
Waldner AG

Richard Denk,
SKAN AG, Chair

Oliver Gottlieb,
nne (Denmark)

Dr. Friederike Hermann,
Lonza AG

Uwe Hahmann,
HET Filter Ltd.

Kolja Klein,
Pharmaplan AG

Daniela Kovats,
Excella Pharma Source

Dr. Reinhold Maeck,
Boehringer Ingelheim GmbH

Michael Maintok,
Glatt GmbH

Martin Pernau,
Bayer AG, Co-Chair

Jessica Redmer,
AiCuris Anti-infective Cures Ltd.

Markus Rückert,
Pharma Containment Solutions

Dr. Martin Schöler,
Fette Compacting GmbH

Dr. Andreas Schreiner,
Novartis Phama AG

Bernhard Steidle,
R-Pharm Germany GmbH

Karsten Wolka,
LS-tec GmbH

Joerg Ziska,
Hüttlin GmbH