Bio-Chem Offers Data Loggers for Critical Parameter Monitoring

Bio-Chem Engineering is now offering the monitoring and analysis of temperature, relative humidity and other critical parameters using the most accurately-calibrated data loggers available.

The software for the data loggers is FDA 21CFR part 11 compliant and meets all the standards of the biopharma industry.

Uses for the data loggers include:

1. Warehouse validation

2. Refrigerator, cold rooms, Freezers and Revco thermal mapping

3. Incubators validation and temperature, relative humidity and CO2 mapping

4. Cryogenic tanks thermal mapping

5. Stability chambers validation,temperature and relative humidity mapping

6. Product packaging validation

7. Supply chain validation

8. Shipped product parameters monitoring around the world

9. Autoclave thermal and pressure mapping and validation

10. Oven thermal mapping and validation

11. Controlled and clean room temperature and relative humidity mapping and validation

Bio-Chem helps companies develop and troubleshoot production processes, establishing Quality Assurance systems, GMP and supporting validation activities.

Founded by Eran Yona, Bio-Chem has successfully helped more than 50 companies reach clinical production, establish large-scale production and qualify facilities for marketing products after receiving FDA/CE approval.

To do so, Bio-Chem assists with Chemistry Manufacturing and Controls (CMC), GMP and Engineering documentation, the selection of preferable technology, Quality Assurance, GMP, external audits, as well as the planning of clean rooms, including the architecture and conceptual design. The company continues to offer services throughout the scale-up and quality improvement stages.

Bio-Chem has worked with a wide range of Israeli and multinational biopharma and medtech companies. Among them: Kamada, BTG, Omrix, Teva, Taro, Sigma Aldrich, BrainStorm, Navotech, Valtech, Neopharm, Chiasma, Prolor, Clalit, Eticon, AB Dental, Sealantis, BioLine RX, Colbar and HyLabs.

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