Biomatic Validates
ESPEC Environmental Chamber
in a GLP/GMP Environment

Stoughton, MA (August 30, 2003) --Biomatic is pleased to announce the IQ, OQ, PQ validation of the ESPEC Lab Series Environmental Chamber, Model LHU-113, in a GLP/GMP environment.

The validation of ESPEC’s high-end temperature and humidity controlled environmental chamber was performed for a pharmaceutical client in New Jersey.

The LHU-113 is a compact bench-top environmental chamber, suitable for a wide variety of applications. Pharmaceutical, automotive, materials, and electronic industries have all found these models to be useful for temperature and humidity testing.

Validation Protocol Developed 

The complete IQ, OQ, PQ validation of the ESPEC Model LHU-113 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 Installation Qualification (IQ) process, Biomatic's technical staff installed the ESPEC Model LHU-113 environmental chamber based on the vendor’s guidelines and the IQ protocol. The IQ included:

The Operational and Performance Qualifications (OQ/PQ) of the environmental 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 and humidity mapping and recovery, 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 LHU-113 showed the temperature and humidity recovery after opening the door for 30 seconds and placing two boxes inside the unit was less than 10 minutes, a remarkable recovery time. In addition, the temperature uniformity and temperature and humidity stability/accuracy were excellent when compared to other standard lab incubators.

The table below shows the temperature and % humidity stability of the ESPEC LHU-113 during a 20-hour test period based on the results of a NIST Traceable Dickson TR320 temperature-humidity sensor/recorder positioned in the middle of the unit.

The ESPEC LHU-113 uses an inner glass door to ensure a controlled environment. The inner door option permits visual access to the chamber without disrupting conditions in the unit. A 1-inch diameter cable port allows wires and cables to be run to samples. The controller is programmable with up to nine steps to allow controlled ramps of temperature and humidity. Repetition of the program can be done up to 999 times. Delayed starts and stops of tests are also possible. 

Customized Services 

The validation of ESPEC’s LHU-113 environmental chamber continues Biomatic’s practice of customized validation services. 

Biomatic has performed IQ OQ PQ/PV validation 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.