ISPE Briefs: New Guide Explores Best Practices in Pharmaceutical Containment
“Over the past 20 years, there have been an increasing number of highly potent materials handled within the pharma industry, to the point where most modern products require some degree of containment or other exposure control to maintain safety,” said guide team member Peter Marshall, AstraZeneca (retired).
The ISPE Good Practice Guide: Containment for Potent Compounds covers all aspects of pharmaceutical containment, including background to safe working levels, mechanisms of exposure, and how 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.
“In most countries, there is a hierarchy of measures to avoid risks: from elimination of the material to finally PPE. Containment (engineering controls) are amongst the preferable measure to be taken. PPE is the last barrier of defense,” said guide co-lead Dr. Rainer Nicolai, Product Owner Engineering Consulting, F. Hoffmann-La Roche Ltd.
Developed by a multinational team of experts consisting of engineers, toxicologists, hygienists, and analysts from major pharmaceutical companies and suppliers, the 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, transfer ports, air locks, filtration systems, containment performance assessments, and cleaning/waste treatment. Additional topics include GMP aspects, containment systems’ life cycle, unplanned emission/spillage recovery procedures, and the development of a containment strategy.
Meet the ISPE Staff: Heather Patterson
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Heather Patterson, Human Resources Manager.
Tell us about your role at ISPE: What do you do each day?
I am responsible for compensation management and payroll, benefits administration, employee relations, talent acquisition, and regulatory and compliance management.
What do you love about your job?
I love helping people and I get to do that in so many different ways in this role. Talent acquisition is one of my favorite parts of my job. I love meeting new people and sharing information about ISPE with them. ISPE is always looking for new talent. Our latest career opportunities are posted at ispe.org/about/careers
What do you like to do when you are not at work?
I was born and raised in southeast Texas and I enjoy spending time with my family. We love to go hunting, saltwater fishing, and traveling to the mountains. One of my hobbies is photography, so I enjoy taking landscape and wildlife photos when we travel. When I’m at home, I love to cook for my family and friends.
