B Medical Systems Pharmaceutical Storage Cabinet | Complies with DIN 13277 & FDA Standards in Drug Storage
Product code: BMPF | Brand: B Medical
In pharmaceutical management and cold chain, maintaining a stable temperature range of 4°C-15°C is a technical requirement to preserve the pharmacodynamics of drugs and vaccines. The B Medical Systems (Luxembourg) pharmaceutical storage cabinet is a specialized medical device, designed to meet international safety specifications and certifications in hospital environments.
Technical Standards and Medical Device Certifications
The B Medical Systems P-Range pharmaceutical refrigerators ensure compliance with the most stringent drug storage requirements:
- EU MDR (Medical Device Regulation) Compliance: The equipment is classified as a Class I Medical Device under Regulation (EU) 2017/745, confirming its safety, operational performance, and clinical efficacy according to European Union standards.
- DIN 13277 Standard (Germany): The devices meet the technical specifications of the DIN 13277 standard, specifically for medical refrigeration. Key performance indicators include Temperature Uniformity and Recovery Time, which minimize thermal fluctuations affecting preparations, even with high-frequency door openings.
- US FDA Class I Certification: The products comply with 21 CFR Part 862.2050, meeting the technical conditions for distribution in the U.S. market and healthcare systems adhering to FDA standards.
- FDA 21 CFR Part 11 Compliance: The °B Connected management software supports data traceability, ensuring Data Integrity and providing comprehensive Audit Trails. This feature standardizes temperature logging processes for quality auditing purposes.
- WHO PQS Standards: Leveraging technology from the vaccine cold chain, the equipment integrates a Freeze Protection (Grade A) mechanism, preventing the risk of temperatures dropping below safety thresholds that could denature vaccines.
The implementation of B Medical Systems pharmaceutical refrigerators fulfills the infrastructure requirements for Good Storage Practice (GSP), supporting pharmaceutical quality control within healthcare facilities.
Product Description
Reliability
- Forced air cooling system for uniform and stable temperature distribution
- Fast temperature recovery even in case of frequent door openings
- Safety thermostat preventing temperature below freezing
- Extended autonomy in case of power failure
- Audio-visual alarm system with remote transmission via SMS or email
- °B Connected universal software for remote monitoring, reporting, and long-term archiving in combination with a Data Communication Unit
Efficiency
- Natural refrigerant with high cooling efficiency conforming with US SNAP and EU F-Gas regulations
- Polypropylene cabinets injected with polyurethane foam providing strong thermal insulation
- Sealed gaskets and 4-layer glass window minimizing cold air loss
- Interior automatic LED lighting for lower energy consumption
- One-piece cabinet manufactured with the unique technique of rotational moulding
Convenience
- Smooth cleanable surfaces
- Low-noise appliance
- Low heat emission
- Modular interior equipment
- Organic glass window for better visibility of the refrigerated content
- Easy export of data on USB
- Electronics with temperature display easily accessible
- Gasket heater minimizing condensation
- Lifetime warranty corrosion-free cabinet
