Our Company & History
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 15 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, the main ones being Investor Investment Europe Ltd and Priveq Investment. Today, the PhaSeal System is trusted by and implemented in more than 2000 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-documented 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 19 independent, peer-reviewed, published 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: PhaSeal is supported by Carmel Pharma’s 15+ years of dedicated CSTD research and development.
- Quality: The efficacy of PhaSeal is clinically proven and uniquely validated by 19 independent, peer-reviewed, published studies.
- Ease of Use: PhaSeal’s passive safety technology and built-in locking mechanism makes the System easy to use. The Injector’s unique design allows us to retrieve all the drug from the vial for increased cost savings and no waste.
- Universal Compatibility: PhaSeal is universally compatible with all drugs, standard drug vials (13 mm neck-28 mm neck) and standard luer lock tubing/connections/ports for full-spectrum protection from pharmacy to nursing to waste disposal.
- Ongoing Clinical Support: PhaSeal easily fits within our existing procedures and is able to be customized to fit our unique clinical needs. Carmel Pharma’s dedicated, certified clinical support staff is available to assist with implementation, training and any ongoing needs.
- Compliance: By implementing the only device that meets the NIOSH and ISOPP definition of a CSTD, we’re compliant with the revised USP <797> guidelines, which state the preferred use of a CSTD and clarify that such systems must allow no venting or exposure of hazardous drugs to the environment.
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. Pharmacopeia, 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.
431 53 Mölndal, Sweden
Phone: +46 31 703 04 00
Fax: +46 31 703 04 04
7029 Huntley Road, Suite O
Columbus, OH 43229