MedBAC ™ risk limitation according to DIN EN ISO 7396

Home > ScienceHospital compressed air MedBACMedBAC ™ risk limitation according to DIN EN ISO 7396

Risk limitation according to GMP / DIN EN ISO 7396: 2007

  • Everything at a glance
  • Malfunctions in the compressed air system are detected immediately
  • Hygienic damage in downstream components is avoided
  • Plant can be shut down in case of damage
  • No follow-up costs due to expensive cleaning work and shutdowns
  • Economical use of the filter and adsorption stages (activated carbon hopkalite)
  • High process reliability through continuous monitoring of the purity requirement
  • Tamper-proof data recording for submission to GMP inspections and inspections of official channels.

The modular design of the MedBAC ™ respiratory air monitoring system can be easily integrated in new systems as well as for retrofitting into existing respiratory air supply systems. The MedBAC system gives the pharmacist, as the person responsible for the production of the drug "compressed air for medical use", the necessary safeguarding of the manufacturing process and ensures the continuous and tamper-proof documentation according to GMP regulations. The MedBAC ™ makes an important contribution to the reduction of nosocominal infections.

MedBAC ™ - State-of-the-art Data Acquisition

The functionality, the flexibility, the secure data recording, the informative measured value evaluation and the brilliant display of measured values ​​set the application creativity no limits. The device is easy to use and offers a variety of compelling ways to save costs and simplify data archiving.

On-site operation directly on the device

The dialog-driven operation in the menus is done with Navigator (push-turn-wheel) in combination with 4 control buttons. Alternatively, the transmitter can also be operated via an external keyboard (USB).

High security standard / Applications /

Compliance with FDA 21 CFR 11 equates electronic records and signatures with traditional documents and signatures. Problems with the complex registration on paper (paper jam, paper and pencil changes) are a thing of the past.

Compliance with the FDA 21 CFR 11 and thus the traceability of all processes is ensured at all times by comprehensive safety functions.

Reliable and timely detection of limit violations ensures consistently high quality and reduces operating costs. The transmitter monitors readings and generates meter readings. Switching outputs are assigned to the limit values. These can be switched for alarm forwarding (eg horn, lamp). Alternatively, valves can be controlled. This saves additional devices for alarming.