Carmel Pharma

PhaSeal

Description:
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.

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.”[1] 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.[2]

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.”[3] PhaSeal meets these requirements.

[1] NIOSH ALERT Publ. No. 2004-165 www.cdc.gov/niosh.

[2] Wick C, Slawson MH, Jorgenson JA, Tyler LS. Using a closed-system protective device to reduce personnel exposure to antineoplastic agents. Am J Health Pharm. 2003; 60: 2314-2320.

[3] 2008 USP <797> Guidebook to Pharmaceutical Compounding-Sterile Preparations. Copyright 2008. The United States Pharmacopeial Convention, page 14-15.