Background

Since 1994, IsoTech Design is a leading designer and manufacturer of USP <797> clean air solutions, such as isolators and modular cleanrooms. We have been serving pharmacies for 20 years in sterile compounding, chemo compounding, hormone compounding and sterility testing. We have over 1000 certified facilities across the United States & Canada, who are using our clean air solutions for sterile and chemo compounding while complying with the USP <797>, their state board of pharmacies, OSHA and NIOSH regulations and requirements. Also, pharmacy facilities in 15 countries & 5 continents use our clean air solutions, which have been validated and certified according to their respective norms and regulations.

Mission

IsoTech Design’s mission is: Protecting Life with barrier isolation technology and clean air environments for contamination control, sterility assurance, and containment management.

Our solutions allow

• High level of sterility assurance and operator exposure level (OEL)
• Microorganisms and particle contamination controls
• USP 797 compliance for sterile and chemo compounding
• cGMP and FDA compliance for aseptic processing

Our isolator, RABS and microenvironment systems provide a more cost-effective solution than traditional cleanrooms.

We work very closely with our customers to design barrier systems that meet their needs and all the regulatory requirements, while facilitating their processes.

References

We have over 1200  certified hospitals and pharmacies in North America to the USP 797 and to their state or provincial boards of Pharmacies. We also have over 60 Pharmaceuticals companies who have been validated to the FDA or EC cGMP.

Some of the Hospitals and Pharmacies names include:

• Bayonne Hospital, NJ
• Robert Wood Johnson, NJ
• Umass, MA
• Duke University, NC
• John Hopkins, NC
• Cancer Treatment Centres of America
• Jean Talon, QC
• Bayshore, Canada
• CRSSS, Canada
• Stanford University, CA
• Productos, Mexico
• Cornestone, TX
• Healthsouth, FL, TX
• O’Brien Pharmacy, KS
• DeGarmo Compounding, WA
• Cantrell Drug, AR
• Pharmacy Creations, NJ

Some of the Pharma companies include:

• FDA, GA
• Sanofi Aventis, MA, ON
• Pfizer, CT
• Alberta  Research Council, AL
• Allergan, France, CA
• Intas, India
• Therapia, Chile
• Roche, Mexico & Co
• Pharmidea, Latvia
• Pisa, Mexico
• Wyeth, Canada
• Bayer, CA