APPLICATIONS OF CLEANROOM TECHNOLOGY
Cleanroom technology is used in the manufacturing of sterile and ultra-clean products and devices. This technology is based on the use of High Efficiency Particulate Air (HEPA) filters as well as engineering and procedural controls to provide a contamination-free environment in a determined area. NASA engineered and perfected this technology during the early stages of the manned space rockets program in the 1960’s.
Manufacturing under aseptic conditions is now widely used in the pharmaceutical and medical devices industries. In Europe, Petri dishes have been successfully produced under this method for over thirty years. In North America, Phoenix Biomedical has been a pioneer in the microbiologically controlled Petri dish manufacturing industry.
In 1991, Phoenix Biomedical built a cleanroom facility in Mississauga, Ontario, Canada to produce aseptically assembled Petri dishes. In 2013, the company designed and built a brand-new manufacturing cleanroom facility in Murcia, Spain to continue producing its sterile Petri dishes with the same stringent quality control. Phoenix has the capacity to manufacture over 200 million plates per year in its microbiologically controlled facility. Major distributors, diagnostic device manufacturers, health care providers and research institutions in many countries worldwide purchase these Petri dishes. Phoenix Biomedical adheres strictly to all GMP requirements, and is ISO 9001 registered.
PHOENIX BIOMEDICAL ASEPTICALLY-ASSEMBLED DISHES
From a quality point of view, aseptically assembled dishes are indistinguishable from terminally sterilized Petri dishes. However, aseptically manufactured dishes have the added advantage of being free from chemical residuals produced by some sterilization processes that may inhibit the growth of fastidious microorganisms. Equally important, unlike those produced without the advantage of the HEPA filter, the dishes are now particulate-free. The manufacturing process for Phoenix Biomedical’s aseptically assembled dishes is also environmentally-preferable. No ozone-depleting substances or any other adverse health and environmental effects are produced.
PHOENIX BIOMEDICAL CLEANROOMS
Phoenix Biomedical cleanroom facilities are ISO Class 5 soft-walled rooms. Each room is equipped with state-of-the-art (HEPA) filters. Process and product conformance are assured by controls and procedures outlined in our extensive Environmental Monitoring Program. More importantly is the air cleanliness, temperature and relative humidity control and rigorous clean floors.
Environmental Monitoring Program
This key program ensures the proper functioning of Phoenix Biomedical cleanrooms. All aspects of the program are described in well-documented procedures and are strictly followed.
The Environmental Monitoring Program includes different tests performed to recognized standards (US Pharmacopoeia, ISO 14644), as well as Phoenix Biomedicals’ critical standards and specifications. High-tech equipments such as the Handheld Aerotrak Particle Counter and the Merck MAS-100 Microbiological Air Sampler, are used to monitor airborne particulate. Product sterility testing is regularly conducted by an independent microbiological testing laboratory. A Sterility Certificate is issued for each lot manufactured and is retained in our master file; certificates are forwarded to our valued customers upon request.
All clean area operators are trained by a formal and well-documented program. Operators participate in an initial comprehensive training session in current cleanroom industry operating procedures, followed by regular on-the-job training.