Climatic cham- bers.
Large-volume stability chambers and cold storage rooms — ICH Q1A compliance and 21 CFR Part 11 monitoring with full traceability.
Large-volume stability chamber.
For long-term, accelerated and photostability studies. Climatic conditions per ICH standards with full regulatory traceability.
ICH conditions
T° / RH control compliant with ICH Q1A — long-term 25 °C/60 % RH, accelerated 40 °C/75 % RH, intermediate 30 °C/65 % RH.
21 CFR monitoring
Monitoring system with a PAC (Programmable Automation Controller) for traceability compliant with 21 CFR Part 11 — electronic signature, audit trail.
Cold storage room.
For raw materials, finished products or quarantine areas — redundant equipment for 24/7 availability and multi-channel alarms.
21 CFR monitoring
Regulatory traceability with electronic signature and a complete audit log.
Redundant equipment
Duplication of chillers and critical components — availability ≥ 99.9 %, automatic failover on fault.
Multi-channel alarm
Instant notification — audible, SMS, phone call. 24/7 on-call with automatic escalation.
Other solutions.
All solutionsA custom climatic chamber?
Tell us about your project — preliminary study, audit or quote request. An engineer will get back to you within 48 hours with an initial technical assessment.