Nicholas Haycocks

Nicholas R. Haycocks was a Senior Specialist QA for Amgen Inc., supporting international distribution quality. In 2006, he joined Amgen’s engineering department and moved to quality in 2009. He is a SME for critical utilities and has worked on projects in a C&Q role in many locations, including China, Singapore, and Kenya. Nick is currently a member of the ISPE HVAC and Sustainability Community of Practice Committee and has been a team member for a number of ISPE Guidance Documents, including the ISPE Baseline® Guide: Commissioning and Qualification, the first edition of the ISPE Good Prac-tice Guide: Good Engineering Practice, the ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning, the first edition of the ISPE Good Prac-tice Guide: Controlled Temperature Chambers, and the ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems. He has been a member of ISPE since 2002.

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Technical
Room Differential Pressures in Facility Design: Fundamentals

The expectations for room differential pressures to maintain air quality in pharmaceutical facility design are consistent and well defined from a regulatory perspective. However, there is no common approach to the design, monitoring, or alarming of area differential pressures. This article explores differential pressure concerns in aseptic manufacturing, or cleanroom classes B, C, and D.

A Sustainable Approach to Steam Quality Management
Technical
A Sustainable Approach to Steam Quality Management

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...

Figure 1: Thermal energy capacity: steam versus electricity.
Technical
Introduction to Steam Quality and Testing

Steam is the most powerful and effective thermal energy transfer fluid, and its use continues to grow in process industries around the world. However, there is very little written about the commissioning and qualification of pharmaceutical pure steam systems in GMP regulations or regulatory guidance. This article provides the background and science behind the steam quality tests and proposes a...

Figure 1: Seasonal comfort (temperature and RH). ©ASHRAE, www.ashrae.org. Used with permission from 2017 ANSI/ASHRAE Standard 55 [4].
Technical
Temperature & Humidity Requirements in Pharmaceutical Facilities

Defining room temperature and humidity limits is a frequent topic of debate when designing and operating pharmaceutical and biotechnology facilities. What are appropriate alarm limits and acceptable durations for an alarm condition? Understanding the source of temperature and humidity requirements, and strategies for setting limits, can ensure both compliance and optimum use of energy. This...