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Cleanrooms: A Question & Answer Document from Baxa Corporation is Now Posted on for Media and Professional Access

"Understanding Cleanrooms: Answers to Frequently Asked Questions," authored by Pat Hynes, VP of Global Quality for Metro Denver-based Baxa Corporation is now posted for media and professional access on The American Society of Health-System Pharmacists (ASHP) released USP 797 in January 2004 and the National Institute for Occupational Safety and Health (NIOSH) published its 2004 alert on the health risks posed to those working with hazardous drugs.

Denver, CO, February 27, 2005 --( With hazardous drug handling brought to the forefront of public scrutiny in 2004 by the American Society of Health-System Pharmacists (ASHP) USP 797 and a (PRWEB) February 27, 2005 -- related National Institute for Occupational Safety and Health (NIOSH) Alert, Baxa Corporation has published a detailed question and answer document exploring the topic of cleanrooms. The Cleanroom Q&A is now posted on (click the Cleanrooms tab) for both professional and media access, according to Greg Baldwin, Chairman and CEO of Baxa Corporation. Baxa is the US distributor of PhaSeal®, the only closed system that prevents the workplace contamination threats as delineated in the NIOSH Alert.

"The USP General Chapter 797 on compounding sterile preparations makes some specific recommendations regarding cleanliness and cleanrooms. While it does not specifically require a cleanroom for sterile compounding, the guideline does require that sterile compounding take place in a separate area that meets a defined level of cleanliness. Many pharmacists have expressed concern about cleanrooms and their requirements in an attempt to clarify the requirements for USP 797 compliance. The discussion now posted on the is intended to provide a general understanding of what cleanrooms are and how they are monitored," says Baldwin.

"Understanding Cleanrooms" is found at This paper is authored by Baxa Corporation’s Pat Hynes, VP of Global Quality.

Hynes has more than 20 year’s experience in quality assurance and regulatory affairs activities. At Baxa Corporation, he has been involved in critical strategic initiatives for adopting lean manufacturing processes and Six Sigma implementation. He is a recognized expert in cleanroom design and requirements both through his work at Baxa Corporation and with COBE Cardiovascular worldwide. Hynes’ previous employment includes positions in new product development, manufacturing management and product evaluation. He was instrumental in the development of Baxa Corporation’s current quality system and is responsible for the enforcement of Quality System Requirements (QSRs). He holds a BS in Biology with a minor in Chemistry.

Baxa Corporation, as mentioned above, offers the only closed system for safe handling of antineoplastic and other hazardous drugs. This system, PhaSeal, uses dry connections and a built-in expansion chamber to prevent drug aerosol leakage and subsequent transfer into the work environment. As a closed system, it contains hazardous drugs throughout the entire process of drug transfer, preparation, transport, administration and disposal - eliminating the risks of environmental and occupational exposure.

The PhaSeal System is currently in use for handling hazardous drugs in more than 200 leading cancer hospitals in the US. The system is also used in progressive hospitals throughout Europe.

A leading provider of devices and systems for the preparation, handling, packaging, and administration of liquid medications, Baxa Corporation manufactures and markets a wide range of healthcare products for use in hospitals, critical care units and alternate-site pharmacies. Headquartered in Englewood, Colorado, Baxa has subsidiaries and sales offices in Canada, the United Kingdom; Denmark, and Germany; and distribution partners worldwide. Further information is available at

The PhaSeal System is manufactured in Sweden by Carmel Pharma ab of Göteborg, Sweden. Introduced in Europe in 1994, the PhaSeal System is now used in most Swedish hospitals, with its benefits documented by a significant body of scientific research on the health risks associated with the preparation and administration of cytotoxic drugs. The PhaSeal System is protected by a comprehensive patent portfolio in the U.S., European Union and Japan. For more information on Carmel Pharma, please visit

Additional resources regarding this subject matter:




"What if the Cure is Also a Cause?
The Same Chemo Drugs That Save Some Cancer Patients' Lives Put Health Workers at Risk"

Click the following link to view a presentation by Jim Jorgenson "Using a Closed System Device to Reduce Occupational Exposure to Hazardous Drugs." Jorgenson is Director of Pharmacy for the Huntsman Cancer Institute and Associate Dean for Professional Affairs at the University of Utah:

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Marian Robinson, Vice President, Marketing
Baxa Corporation: 800.567.2292 ext. 2157 or 303.617.2157

Maggie Chamberlin Holben, APR, Absolutely Public Relations
303.984.9801, 303.669.3558
Contact Information
Baxa Corporation
Marian Robinson
800.567.2292 ext. 2157 or 303.617.2157
Maggie Chamberlin Holben, APR
Absolutely Public Relations: 303.984.9801 or 303.669.3558

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