Carmel Pharma is the manufacturer of the PhaSeal® System, today’s only clinically proven closed-system drug transfer device (CSTD) for the safe handling of hazardous drugs. Supported by more than 14 years of experience focused solely on the development of PhaSeal, Carmel Pharma offers a level of trust, quality and confidence that is unparalleled in the safe handling industry.
Carmel Pharma was founded in Gothenburg, Sweden in 1994 and has played an active role in the Swedish medical market ever since. In October of 1999, the company expanded its safe handling initiatives to the U.S. market with the formation of Carmel Pharma, Inc., which operates a corporate office and distribution facility out of Columbus, OH. The exclusive U.S. distributor of PhaSeal since 2006, Carmel Pharma has more than 200 shareholders, including Investor Investment Novare Ltd and 3i Nordic. Today, the PhaSeal System is trusted by and implemented in more than 1000 cancer facilities, infusion centers and private practices across 30+ countries, including M.D. Anderson and Texas Children’s in Houston, TX; City of Hope in Duarte, CA; Dana Farber Cancer Institute in Boston, MA; and SwedishAmerican Hospital in Rockford, IL, just to name a few.
Carmel Pharma’s mission is to improve the quality of life of those who prepare, administer and handle waste from hazardous drugs by providing PhaSeal, a unique CSTD with scientifically-proven benefits.
PhaSeal is more than a system for the safe handling of hazardous drugs. It’s the only clinically proven CSTD available on the market today and is validated by more than 10 independent, peer-reviewed, published clinical studies. Distinguished by prominent thought leaders as the “Gold Standard” in safe handling, PhaSeal’s airtight Expansion Chamber and dry, leakproof connections prevent exposure to hazardous drugs, including aerosols and vapors. Its streamlined design and universally-compatible components make the system easy to use from preparation and administration to waste disposal.
PhaSeal System Advantages
- Experience – Carmel Pharma has more than 14 years of experience focused solely on the development of CSTDs
- Quality – The PhaSeal System is backed by more than 10 independent, peer-reviewed, published clinical studies and is the only clinically proven CSTD available today. Its unique airtight Expansion Chamber and dry, leakproof connections make it the only device that meets the NIOSH and ISOPP definitions of a CSTD
- Compliance – As the only CSTD available, PhaSeal keeps facilities compliant with the revised USP 797 safe handling guidelines
- Savings – PhaSeal’s intuitive Injector Luer Lock N35 is both easily and safely manipulated using a turn-key motion and allows all of the drug to be retrieved from the vial to generate cost-savings
- Validation – Regularly scheduled wipe study analyses illustrate PhaSeal’s efficacy in preventing surface contamination (and thus human uptake)
- Support – Carmel Pharma’s comprehensive team of clinical, reimbursement and marketing experts ensure seamless implementation and provide ongoing resources and support
Necessity and Efficacy
In 2004, NIOSH published an alert that states “working with or near hazardous drugs in health care settings may cause skin rashes, infertility, miscarriage, birth defects and possibly leukemia or other cancers.” A direct investment in the health and wellbeing of today’s valued oncology staff, the PhaSeal System has been proven to prevent exposure to these risks.
In 2003, the state-of-the-art Huntsman Cancer Center in Salt Lake City, UT sought to determine the risk of human exposure to hazardous drugs across its pharmacy and nursing facilities. To do so, urine samples were collected from three test groups of pharmacists, technicians and nurses – both prior to and following implementation of the PhaSeal System. The baseline samples confirmed the presence of hazardous drugs across all three groups. Following the six-month period during which PhaSeal was used, however, this previously evident human uptake of hazardous drugs was reduced to zero percent, clearly illustrating the efficacy of the product.
Implementation of PhaSeal also helps facilities maintain compliance with the revised USP 797 safe handling guidelines. Issued by U.S. Pharmacopoeia, these guidelines govern a wide range of pharmacy policies and procedures designed to protect both patients and pharmacy staff. USP 797 states that CSTDs are preferred when handling hazardous drugs and clarifies such devices as being “vial transfer systems that allow no venting or exposure of hazardous drugs to the environment.” PhaSeal meets these requirements.
Carmel Pharma, Inc. is the primary U.S. distributor of the PhaSeal System. Increasing distribution of PhaSeal to the veterinary market is handled by The Apothecary Shop. For information regarding availability, please contact the U.S. corporate office at: 866-487-9250.
Dan Pitulia, CEO
David Schneider, President, North America
7029 Huntley Road, Suite O
Columbus, OH 43229
Phone: 866-487-9250
Fax: 614-841-0525
www.carmelpharma.com
www.carmelpharmausa.com
www.phaseal.com
Emily Frydendal, PR Coordinator, Carmel Pharma, Inc.
emily.frydendal@carmelpharma.com
Phone: 614-318-2635
Christine Crooks, Director of Marketing, Carmel Pharma, Inc.
christine.crooks@carmelpharma.com
Phone: 614-318-2622
