Background
BioCold Environmental designs and manufactures controlled environment rooms, FDA/ICH compliant stability chambers, and laboratory incubators used by pharmaceutical companies and research institutions to maintain the precise, stable temperature and humidity conditions required for product stability testing and scientific research. At the center of BioCold's chambers is the BioLogic Touchscreen Interface, which gives lab personnel straightforward control over environmental setpoints along with secure data logging and remote monitoring capabilities.
IVC Displays has supplied the industrial touch screen computers behind that interface since 2008, along with ongoing application support and consulting as BioCold's control requirements have evolved.
The Challenge
BioCold's customers operate in FDA regulated environments, where precise, stable environmental conditions are not simply a matter of product quality. They are a regulatory requirement. A stability chamber that drifts outside its validated temperature or humidity range, even briefly, can compromise or invalidate months of pharmaceutical stability testing data.
BioCold needed a touch screen computing platform that could support continuous, accurate monitoring and control of environmental conditions over long, often unattended test cycles, while also meeting the data integrity and audit trail expectations that come with FDA and ICH stability testing guidelines and regulations such as 21 CFR Part 11. General purpose, consumer grade computing hardware could not be relied on to run accurately and continuously for the extended durations pharmaceutical stability testing demands.
The Solution
Since 2008, IVC Displays has supplied BioCold with industrial grade touch screen computers built for the kind of continuous, dependable operation that regulated environmental control requires. These systems form the hardware foundation of BioCold's BioLogic Touchscreen Interface, giving lab technicians a straightforward way to set and monitor temperature and humidity conditions while the underlying platform reliably logs data for compliance and audit purposes.
Beyond supplying the hardware itself, IVC has provided ongoing application support and consulting, working alongside BioCold's engineering team as chamber designs, control requirements, and compliance needs have evolved, rather than simply delivering a one time hardware order.
Results
- A dependable control platform. Industrial touch screen computers built for the continuous, unattended operation that regulated stability testing requires.
- Support for regulatory compliance. A hardware platform suited to the data integrity and audit trail demands of FDA/ICH stability testing and 21 CFR Part 11.
- A long standing technical partnership. Nearly two decades of hardware supply, application support, and consulting since 2008.
Looking Ahead
IVC Displays continues to serve as BioCold Environmental's touch screen computing partner, pairing dependable industrial hardware with the application support and consulting that helps BioCold's controlled environment rooms and stability chambers keep pace with the evolving needs of pharmaceutical and research customers operating in tightly regulated environments.
