Nicholas Haycocks

Amgen Inc
Senior Specialist QA
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. I am a subject matter expert for critical utilities and have worked on a number of projects in a commissioning and qualification role, in many locations including China, Singapore and Kenya.

I am currently a member of the ISPE SFHCE and C&Q Community of Practice Committees, I have been a team member for a number of the ISPE guidance documents including the Commissioning and Qualification baseline guide, the first edition of the Good Engineering Practice Guide, the HVAC Good Practice Guide, CTC Mapping Good Practice Guide and the Water and Steam Commissioning Good Practice Guide. Through this I have been fortunate to meet and learn from some amazing people.

Related Articles

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...