Cleanrooms: A Question & Answer Document from Baxa Corporation is Now Posted on PublicRelationsNewsroom.com for Media and Professional Access In Light of the Continued Regulatory Focus on Hazardous Drug Handling in the Workplace
"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 PublicRelationsNewsroom.com. Since 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, there has been a renewed industry-wide focus on safety within the hospital pharmacy environment. The posted Q&A is intended to provide a general understanding of what cleanrooms are and how they are monitored.
Englewood, CO (PRWEB) 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 www.PublicRelationsNewsroom.com (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 PublicRelationsNewsroom.com is intended to provide a general understanding
of what cleanrooms are and how they are monitored," says
Baldwin.
"Understanding Cleanrooms" is found at http://www.publicrelationsnewsroom.com/_wsn/page7.html. 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 http://www.baxa.com.
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 http://www.carmelpharma.se.
Additional resources
regarding this subject matter:
UNDERSTANDING USP 797
http://www.publicrelationsnewsroom.com/_wsn/page4.html
ENVIRONMENTAL
CONTROLS FOR STERILE COMPOUNDING
http://www.publicrelationsnewsroom.com/_wsn/page6.html
SAFE
HANDLING OF HAZARDOUS DRUGS IN THE WORKPLACE: EXPERT PERSPECTIVES
http://www.expert411.com/_wsn/page9.html
"What if the
Cure is Also a Cause?
The Same Chemo Drugs That Save Some Cancer Patients'
Lives Put Health Workers at Risk"
A MAJOR DAILY NEWSPAPER LOOKS AT THIS ISSUE
IN DEPTH: February 15, 2005
http://www.washingtonpost.com/wp-dyn/articles/A24458-2005Feb14.html?referrer=emailarticle
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:
http://www.isips.org/presentations/PhaSeal/player.html
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Source : http://www.prweb.com/releases/2005/2/prweb212889.htm