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Barrier Isolator Compliance
Background Since 1971, Filtration Technology Inc. stands as one of the most experienced sources for Serparative Devices such as Barrier Isolators and other Laminar Air Flow Equipment. Our principal, Richard A. Matthews, has been the World Chairman for the International Standards Organization (ISO) Technical Committee for Global Cleanroom Standards and Associated Controlled Environments for the past 12 years. USP 797 refers to these ISO Global Cleanroom Standards; specifically the ISO 14644 series of standards. The ISO Standard for Barrier Isolators is addressed in ISO 14644-7. A Choice between a Cleanroom and a Barrier Isolator must be determined based upon your process. Controlled clean environments commonly referred to as Cleanrooms can be expensive spaces. A self-contained, controlled, clean environment enclosure, A Barrier Isolator, around a critical care process area can be an economical alternative to a Cleanroom. To read an article titled “Controlled Clean Environment Enclosures by Richard Matthews, click here. Simplicity and efficiency are necessary features of a specialized Separative Device that requires professional attention to your functional process. Determining your Risk Level In order to determine whether or not you will choose a Barrier isolator or an ISO Cleanroom you must first determine your Risk level.
Low-Risk Level Compounding
Medium-Risk Level Compounding
High-Risk Level
Allow us to become a team member to assist you in determining your requirements. We can provide you with a no cost audit that consists of a site survey, particle counts and a written report. Our commitment to high quality standards has created reliable specialty filtration and contamination control systems that bring the advantages of our technology to your facility. Our team of professionals will work with you to determine your application's specific needs, considering both your immediate and long-term goals. Our experience with sterile compounding facilities in hospital pharmacies, home infusion pharmacies and retail pharmacies will help you determine your requirements. |
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Filtration Technology, Inc. P.O. Box 18168 -- Greensboro, NC 27419 Tel (336) 294-5655 -- Fax (336) 854-0454 • E-Mail: sales@filtrationtechnology.com Customer Service Telephone: 800-338-4280 Web Design by BĒM Interactive |
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