Amgen Selects Biomatic
for IQ OQ PQ Validation in California

Stoughton, MA (Feb. 19, 2003) -- Biomatic Technologies received one of its largest instrument validation contracts from Amgen Inc. (www.amgen.com), the world’s largest biotechnology company, and is now in the process of providing IQ, OQ, PQ validation for the biotech leader. 

Biomatic was selected based on the company’s experience, thoroughness of IQ, OQ, PQ documentation, and competitive pricing. The Metro Boston company is teaming up with its West Coast partner, Full Spectrum Analytics, for the project, which will provide Amgen with on-site IQ, OQ, PQ validation customized to meet Amgen’s requirements and GLP specifications.

Biomatic will provide validation for numerous temperature-controlled devices including:

This equipment is used for the storage and testing of various samples in quality control and research facilities in Thousand Oaks, CA.

IQ, OQ, PQ validation of temperature-controlled devices typically includes confirming proper installation, compiling documents for each unit, verifying calibration, performing diagnostic and alarm tests, confirming alarm verification through clients’ on-line monitoring system, and finally conducting performance qualification that includes temperature recovery after loading samples and short term (1 hour) and long term (24 to 48 hours) temperature mapping using 9-point NIST / vendor traceable thermocouples and data loggers. The final validation report includes certificates of calibration for all devices used; completed IQ, OQ, PQ protocols; hard copies of the raw and analyzed data and related attachments; and another copy of all data on a CD-ROM.

One major area of concern for gathering and processing data is 21 CFR Part 11 compliancy. Biomatic’s innovative process includes a unique Excel template / data logger that automatically collects and processes data. The Excel datasheets and the corresponding equations are password protected to eliminate data tampering and test results are burned onto a CD-ROM to comply with 21 CFR Part 11 rules.

Biomatic Technologies Inc., a Boston-area based biotechnology company, provides:

In addition to its Boston-area main office, Biomatic has additional offices in Raleigh, North Carolina, and in Connecticut at Bayer’s Pharmaceutical Division in West Haven.

Biomatic’s North Carolina office recently finished assisting BASF Corporation Research & Development in its move to North Carolina’s Research Triangle Park from Princeton, N.J. Biomatic's services for BASF included inventory of all laboratory assets and IQ OQ PQ validation for a range of sophisticated laboratory instruments including HPLC, LC/MS, GC/MS, spectrophotometers and other instruments. 

At Bayer, Biomatic provides on-site laboratory equipment service and repair, calibration, validation, and document maintenance.