Clinical Supplies
Facilities
http://www.clinical-supplies.de/facilities.php

© 2011 Clinical Supplies

Manufacturing

Hubertus pharmacy holds:

  • two GMP conform manufacturing rooms (18m² each) including laminar air flow bench;
    • personal- and material lock
    • clean room classification (class D or ISO 8)
    • air conditioning and permanent temperature and humidity monitoring
    • qualified equipment for the specific manufacturing activities
  • separate labelling room for labelling activities of primarily packaged dosage forms
  • emergency backup generator in case of a power cut

Storage

Hubertus pharmacy holds:

  • 1,000 m² storage area for study drugs to be stored at room temperature (15°C – 25°C)
  • 35 m² in cooling cells at 2°C - 8°C
  • three deep freezers for frozen goods up to -50°C
  • all storage areas under permanent temperature and humidity monitoring
  • separate quarantine areas for all storage temperatures
  • separate storage areas for reserve- and retention samples (also in accordance with the FDA requirements)
  • separate storage area for returns of study medication from study sites (worldwide)
  • restricted access to all storage rooms
  • registration as known consignee = „bekannter Versender“ at the German Federal Office of Civil Aeronatics
  • alerting system in case of temperature out of range for all storage areas
  • alerting system in case of burglary and power failure