Pharmaceutical ICH Stability Climatic Chambers

The model CPH chambers, with precise control of temperature and relative humidity allow for long term pharmaceutical tests that conform to the ICH specifications in the sections according to the Q1A guide:

– ICH Long term test +25°C +/- 2°C / 60% RH +/- 5% RH
– ICH middle term test +30°C +/- 2°C / 65% RH +/- 5% RH
– ICH accelerated term test +40°C +/- 2°C / 75% RH +/- 5% RH

In the pharmaceutical industry the maximum safety level comes virtue of the validation against the FDA 483 specification. This equipment has been designed exclusively for the pharmaceutical sector with, on request, the documentation of the most rigorous validation IQ, OQ, PQ & CQ.

Included in the standard version

  • Multi-color touch panel/32 Bit Controller
  • Service-friendly capacitive humidity measurement system
  • Single-hand operated door handle, lockable
  • Entry port ∅ 50 mm
  • 6 shelf, stainless steel for CPH 6 & 12 for CPH 12
  • Error display in plain text
  • Potential free contact for malfunction signal
  • RS 232 interface
  • Service-friendly construction
  • Minimum noise level
  • Simple user-friendly operation and programming
  • Low power-consumption datas
  • Optimized parameters for highest testing precision
  • Complies with current CE and EMC regulation
  • Control: microprocessor control and monitoring system
  • Test space: stainless steel grade 1.4301
  • Mobile design

Options

  • entry ports ∅ 50 mm, 80 mm
  • Shelves
  • Panoramic window
  • Hand-hole in the door
  • Pt 100 for temperature measuring on test specimen alternative reversible to controller function
  • Test specimen alternative reversible to controller function
  • CID software for programming and documentation
  • Alarms
  • Validation documentation IQ, OQ, PQ & CQ

For more information on the products or if you require a quotation, do feel free to fill in the form.