Temperature & Humidity Requirements in Pharmaceutical Facilities

About the Author

In my current role I support International Distribution Quality. I began working in Amgen in the engineering department in 2006, moving to Quality in 2009...

Norman A. Goldschmidt

President

Genesis AEC

Norman Goldschmidt is President of Genesis Architects, Engineers & Constructors. He has over 35 years of experience in engineering management, planning, design and construction in...

Ulla Thomsen

SME HVAC

Novo Nordisk A/S

Ulla Thomsen is HVAC specialist for Novo Nordisk, working with pharmaceutical HVAC design, validation and energy savings. She has been with Novo for 16 years...

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Selection Criteria for Pharmaceutical Containment Equipment

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Pharmaceutical manufacturing facilities produce a variety of products, including highly potent products that require safety measures to prevent adverse health effects on patients and operators. To ensure safety, these facilities use containment equipment to minimize the risk of contamination. This article presents criteria for selecting containment equipment, considering both...

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A Sustainable Approach to Steam Quality Management

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The world is beginning to grasp the huge challenge of achieving net-zero carbon emissions, or carbon neutrality, by 2050. Many countries have committed to achieving this ambitious goal. As a major global industry, the pharmaceutical sector has a significant role to play. For thermal energy–intensive industries, such as pharmaceutical manufacturing, the long-term future options to maintain...

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Concluding Compliance Challenges with Validation 4.0

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As the pharma industry moves to an ambitious Validation 4.0 paradigm, computerized systems play a pivotal role in enabling the rapid transition. Innovation and agility in computerized system validation (CSV) received a strong push in the second half of 2022 with the publication of the FDA draft guidance on “Computer Software Assurance for Production and Quality System Software”

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