West Pharmaceutical Services, a manufacturer of packaging components and delivery systems for injectable drugs and healthcare products, recently expanded capabilities at its facility in Scottsdale, Ariz. The site, first built in 1978, underwent a complete renovation in 2011 to transform the facility and enable manufacturing in ISO 7 controlled environments. It features three ISO 7 (Class 10,000) and one ISO 8 (Class 100,000) controlled environments for the manufacture of products. The facility’s latest update will accommodate the company’s pursuits into wearable injectors.
Controlled Environments spoke with West Pharmaceutical Services about its recent facility expansion.
What kind of instruments and equipment are used in the clean area?
instrumentation. All controlled environments are continuously monitored by an automated monitoring system that tracks particulate levels, pressure differential, temperature, and relative humidity.
How many employees do you have, and from where are they recruited? What kind of educational background do they have?
There are more than 100 employees at the facility. Employees come from a variety of industries including — but not limited to — aerospace, general manufacturing, and medical device. Educational backgrounds also vary, but primarily include engineering, microbiology, business administration, finance, and information technology.
Describe the cleaning process — does your research staff perform these duties, or do you hire it out?
We perform our own cleaning. Controlled environments are cleaned once a week and gowning rooms are cleaned daily with LpH. Once a quarter, we use bleach solution in the cleanrooms and gowning rooms as sporicidal cleaning.
Do you have a separate area for gowning?
Controlled environments have a separate gowning area which is certified and qualified annually along with the actual controlled environment per the ISO 14644 standard. All gowning areas are constructed based on the cascade, or higher to lower air pressure principle to assure any air flow moves from a cleaner to less clean area. Additionally, all access doors are interlocked to provide an air lock between the cleanroom and ambient plant space.
What kind of standards and regulations do you follow?
The controlled environments are certified and maintained to the ISO 14644 standard in regard to particulates. ISO 14698 is also used for microbial control.
What are some of the most significant discoveries and research projects that have taken place at your facility?
The Scottsdale facility is responsible for the North American distribution of all Daikyo Crystal Zenith polymer Ready-to-Use Systems. The Daikyo Crystal Zenith Insert Needle Syringe, SmartDose Electronic Wearable Injector, SelfDose Self Injector System, and ConfiDose Auto-Injector System are also produced at the facility. We have also added an in-house microbiology lab and state-of-the-art particle mitigated cleanroom space.
What is the future of the industry, and how cleanrooms will play a part?
One of the most significant topics in the medical industry now is the heightened awareness around particulate contamination in both the visible and sub-visible size ranges. While cleanrooms are an effective tool in controlling particulate loading in an area, the current trend is towards particulate mitigation. This includes the types of items that can be brought into the cleanroom environment as well as the role that static electricity plays in the level of cleanliness achievable in the cleanroom space. Increased awareness of the sources and forces that effect the particulate level in the cleanroom space will continue to play a part in our ability to achieve the level of cleanliness that will be required in medical device and combination products markets.
MaryBeth DiDonna is the Editor of Controlled Environments. She can be reached at firstname.lastname@example.org, or on Twitter: @CEMagazineUS.
This article appeared in the September/October 2015 issue of Controlled Environments.