IceSpy, UK - Applications > Wireless Data Logging in Laboratory Environments |
BioAnaLab,a Specialist Contract Research Organisation (CRO) that offers bioanalytical solutions for the pharmaceutical and biotechnology industry, is the latest of our many research laboratory customers to install the IceSpytemperature logging system, the System5.
Biopharmaceuticals is a rapidly growing sector of the pharmaceutical industry with over 80 biotherapeutics now approved for clinical use. Greater than 30% of all new pharmaceuticals in development are biologics. These drugs provide effective new treatments for a wide range of diseases. BioAnaLab was established to offer contract analysis of biotherapeutics based on the experience of its founders at the University of Oxford.With its experienced and expert team of scientists BioAnaLab offers an analytical service for all protein-based therapeutics such as vaccines, monoclonal antibodies, cytokines, growth factors, enzymes and hormones.
As part of its on-going expansion andtight quality control programme BioAnaLab have invested in IceSpy technology – the latest wireless temperature logging technology – the System5. As a specialist organisation undertaking contract research, BioAnaLab are entrusted with customers’ samples from clinical trials. These precious samples must be kept at the correct temperature and BioAnaLab take a lot of care to ensure this. All measurement equipment must be carefully validated to ensure its accuracy and adherence to 21CFR Part11 procedures is very important.
System5 therefore went through a fully independent validation process to assess compliance with 21CRF Part 11 and other relevant regulatory guidelines. Prof Geoff Hale, CEO of BioAnaLab, stated "After unsatisfactory experiences with the reliability of systems from two other manufacturers, I am delighted to have obtained a temperature logging system which provides all the features we require and has successfully been validated to meet the stringent requirements of the pharmaceutical industry."
In brief, the validation process consists of the following:-
- Design Qualification - Verification that the system includes the functions required by the users
- Installation Qualification: - Checks to make sure the system is installed correctly
- Operational qualification – Verification that the System does what it is intended to do.
- Performance Qualification: - Proof that the system does what it says it does.
BioAnaLab now use the IceSpy system with its calibrated temperature probes as the primary system to continuously monitor the temperatures of all their fridge, freezers and incubators. The electronic data provide a secure record of the conditions throughout the entire sample lifetime of storage and analysis.
Contact details for BioAnaLab
Web site: www.bioanalab.com
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A typical laboratory uses a Multi-point Sensor Monitoring system with external probes and 21 CFR Part II compliant software (requires Extra Secure software license). A Mini System could a good way to start.
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