Duke Medical Center HVTN Labs
Select Biomatic for Equipment Validation
Under GLP Guidelines

Franklin, MA (November 2004) -- Biomatic Inc., a leading IQ, OQ, PQ/PV validation service provider for laboratory instruments, was selected by Duke Medical Center, HVTN Laboratories, to provide complete IQ, OQ, PQ/PV validation services for a range of laboratory instruments and equipment.

The Duke Medical Center HVTN Laboratories is the world-renowned research and testing facility for the AIDS virus (HIV). This center, along with other facilities around the world, is part of the HIV Vaccines Trials Network (HVTN).

The HIV Vaccine Trials Network (www.hvtn.org) is an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN was formed in 1999 by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH).

Biomatic's role in this important mission is to perform IQ, OQ, PQ/PV validation on various storage and testing equipment to verify their suitability and effectiveness under GLP guidelines. The IQ, OQ, PQ/PV validation of a majority of the equipment is being conducted in a regulated safe environment that requires the use of gowns, booties, double-layer gloves, masks, and pass code privileges to enter the facility where testing is conducted.

Biomatic's technical staff is responsible for the OQ, PQ/PV validation of various equipment that require short- and long-term (up to 30 hours) temperature and CO₂ mapping, including:

Biomatic also will be validating other devices, such as centrifuges (speed and temperature verification), plate washers, plate readers, and state-of-the-art flow cytometry instruments.

Biomatic has performed IQ OQ PQ/PV validations on more than a thousand analytical systems and temperature-controlled devices such as environmental chambers, freezers, humidity and CO₂ incubators, standard and walk-in refrigerators, and ovens across the United States.

Our experienced technical chemists validate instruments using real-world testing procedures and NIST / vendor traceable tools and standards. Biomatic's protocols are customized to meet our client's requirements and, as necessary, meet GLP/GMP requirements.

Biomatic is positioned to assist your company, wherever your labs are located. We have offices in the Greater Boston region; at Bayer Pharmaceuticals in West Haven, CT; and the Research Triangle Park, NC. Biomatic also travels across the U.S. providing validation services from California to Florida.

Biomatic invites you to bring your validation and compliance questions to us as well as your other laboratory challenges so that we can improve your laboratory's operation, whether for a GMP/GLP regulated facility or a standard laboratory.