Biomatic validates ESPEC HAST Chamber
for GLP/GMP Client

Franklin, MA (March 2004) -- Biomatic is pleased to announce the IQ, OQ, PQ validation of the ESPEC EHS-221MD HAST Chamber in a GLP/GMP environment. The validation of this specially designed high temperature, humidity, and pressurized chamber continues Biomatic’s practice of customized validation services.

HAST (Highly Accelerated Stress Test) Chambers reduce the time it takes to complete humidity testing. By elevating temperatures above 100°C and increasing pressure, the chambers simulate normal humidity tests while maintaining the same failure mechanisms. But the HAST Chamber tests can be completed in days, not weeks. 

The validation of ESPEC’s HAST chamber was performed for a pharmaceutical client in Minnesota with headquarters in New Jersey.

The ESPEC EHS-221MD HAST Chamber is a dual-chamber floor-standing unit suitable for a variety of applications. Pharmaceutical, automotive, materials, medical devices, and electronic industries have all found these models to be useful for highly accelerated temperature/humidity/pressure test conditions.

Validation Protocol Developed 
The complete IQ, OQ, PQ validation of the ESPEC EHS-221MD HAST Chamber was developed and performed for pharmaceutical use in a GLP/GMP environment. Biomatic developed the protocol in conjunction with the client and the vendor, ESPEC North America Inc. (www.espec.com).

As part of the qualification process, Biomatic's technical staff verified the IQ protocol and the installation of the ESPEC EHS-221MD HAST Chamber by ESPEC technical staff. The IQ protocol included:

The Operational and Performance Qualifications (OQ/PQ) of the ESPEC EHS-221MD HAST Chamber involved verification of all functional features of the system, including:

Automated Data Collection

Biomatic’s OQ/PQ procedure automates data collection and processing for temperature mapping, reducing the need for human intervention and the chance of human error. Automation of the entire data collection and processing permits the printing of raw and processed data -- including graphs -- without any further data manipulation.

Results for the ESPEC EHS-221MD HAST Chamber showed remarkably high temperature accuracy and uniformity within each chamber. Each chamber was loaded with test articles (circuit boards for use in medical devices) and was tested for 10-15 hours under a variety of conditions.

The temperature profile for one of the thermocouples is shown below. 

The temperature accuracy and uniformity of the chamber at various test conditions showed a high degree of temperature stability, as evident from the small temperature differences listed in the chart below. The results reflect testing at 105°C for one hour with temperatures being recorded every 30 seconds.

Customized Services 

The validation of the ESPEC EHS-221MD HAST Chamber highlights Biomatic’s practice of customized validation services. 
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. 

Biomatic's experienced technical chemists validate your laboratory instruments using real-world testing procedures and NIST / vendor traceable tools and standards.

With offices in Massachusetts; at Bayer Pharmaceuticals in West Haven, CT; and Research Triangle Park, NC, Biomatic has the expertise to assess, develop and implement services that your company needs, whether for a GMP/GLP regulated facility or a standard laboratory. With our partner FullSpectrum Analytics, which has offices throughout the West, we are positioned to assist your company, wherever your labs are located.