PHARMACEUTICAL DEVICE STANDARDS
The pharmaceutical industry is subject to heavy government regulation, and pharmaceutical cleanrooms must meet stringent cGMP standards and requirements. The minimum standard for critical zones in pharmaceutical cleanrooms is generally ISO 5 (Federal Standard 209 Class 100). An example of a critical zone could be a sterile cleanroom used for aseptic processing, which would require 240-600 air changes per hour and 35-70 percent ceiling coverage to maintain an environment of 100,000 0.1μm particles per cubic meter. Angstrom Technology designs, constructs, and installs the highest quality pharmaceutical cleanrooms to meet these requirements. We offer modular cleanrooms that can be free-standing, modular units or that make use of your existing wall and structure.
Our HardWall and RigidWall modular cleanrooms make use of your existing walls and are free-standing.
PHARMACEUTICAL CLEANROOM DESIGN
Angstrom Technology also offers pharmaceutical cleanroom designs with multi-stage air filtration systems that make use of prefilters and HEPA filters, a variety of lighting options from standard to flow through modules, and laminar air flow systems that can be integrated with existing HVAC.
Pharma Cleanroom: From Start to Finish
This Angstrom Technology customer works in the pharmaceutical industry and is based in West Michigan. Learn more about this spacious, 32,000 square foot cleanroom project completed in four months’ time!