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 twenty years. In North America, Phoenix Biomedical is a pioneer in the microbiologically controlled petri dish manufacturing industry.

In 1991, Phoenix Biomedical designed and built a facility in Mississauga, Ontario to produce aseptically assembled petri dishes. In the past seven years, Phoenix has produced and marketed over one billion plates in its clean rooms facility. Major distributors, diagnostic device manufacturers, health care providers and research institutions in 50 countries purchase these petri dishes. Phoenix Biomedical adheres strictly to all GMP requirements, and is FDA and ISO 9001-2000 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 of 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 friendly. No ozone-depleting substances or any other adverse health and environmental effects are produced.

Phoenix Biomedical Clean Rooms
Phoenix Biomedical clean rooms are “class 10-100” 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.

Environmental Monitoring Program
This key program ensures the proper functioning of Phoenix Biomedical clean rooms. 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 XXVII, ISO 14644), as well as, Phoenix Biomedical's critical standards and specifications. High-tech equipment such as the Met One 200L Laser particle counter, the Merck MAS-100 Microbiological Air Sampler and the Velocicals Plus Instrument, are used to monitor airborne particulate and microbial surface counts. 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 valuable customers upon request.

All clean area operators are trained by a formal and well-documented program. Operators participate in an initial comprehensive training session followed up by regular on-the-job training. This is achieved by conducting group sessions covering up-to-date standard operating procedures utilizing the Micron Video series, recognized as the best training tool in the pharmaceutical clean room industry.

We would be pleased to provide detailed information on this subject, as well as our ISO 9001-2000 documentation. You are also welcome to tour our facility and observe our one-of-a-kind operation.