Your special requirements deserve special solutions. For this purpose FDM has developed its CUSTOM division. Dedicated volumes, removable doors or exceptional specimens testing are only few examples.
We analyzed and developed things like machines for special mechanical tyres testing, climatic chambers filled with path tracks for mice testing and environmental chambers with special filters or lights.
Our experience and technical innovation skills encounter the quality of ever. This will be with your special requirements and your future FDM CUSTOM chamber.
FDM products offer the best environment simulation. We know how difficult could be keep an high quality and reliability level in your laboratory. To help you bring home your goals we think excellent product isn’t enough. Service is fundamental. You have the freedom to choose between different service package, to take care of your devices and keep your research or business safe.
Stability testing for validation of pharmaceutical products that meet ICH Q1A
The stability testing is a procedure for products validation that meet different standards. The stability chambers are the best equipments for stability studies, and application of use are: Pharmaceutical Products/Packaging; Medical Products/Packaging; Personal Care Products; Consumer Products and Research. This stability chamber can ricreate an ideal environment with temperature, humidity and illumination that are need for test. Temperature range is 0°C to +70°C, humidity range is 10% RH to ±90% RH and the illumination meet ICH Q1A pharmaceutical stability guidelines for different conditions. The pharmaceutical testing require an controller that install the CFR 21 software that meet FDA 21 CFR part 11 compliant. The stability testing is used also for accelated aging test, in order to speed up its aging process on the differents temperature, humidity and lighting conditions.
FDM Stability chambers provide a uniform, temperature/ humidity conditioned environment for worry-free operation with a control system that is easy to use and saves time. These chambers are ideal for ICH Q1A pharmaceutical stability testing, shelf life, package testing, accelerated aging, and more. The Constant Touch Screen Controller is compliance with FDA regulation 21 CFR part 11 for ERES (Electronic Records and Electronic Signatures). The controller is designed to simplify chamber operation including data logging, ethernet control and monitoring from any device, alarm notification via email and/or text message, data fi le backup, full system security, audit trail, digital signatures, power recovery options, and more.
Stability testing – strong points:
Temperature range 0°…+70°C
Temperature stability of ±0.1…0.5°C
Control relative Humidity 10% to 90% ±3%
Constant controller touch screen with CFR 21 software
Data logging with network connection
Inner lexan door with differents compartments
IQ/OQ certifi cations included
GSM Module (optional)
Best quality component for a long-term simulation
Made in Italy Design and Product
Stability testing structure:
External manufactured completely in white plastic coated galvanized steel and internal in stainless steel AISI 304
Polyurethane insulation CFC and HCFC free
Reversible doors fitted with self-closing hinges with stop opening beyond 90° and replaceable magnetic gaskets plug
Inner lexan door for different compartments
Inside with rounded corners
Plastic-coated steel grids removable and height adjustable
Adjustable steel feet
Colour touchscreen display
Peer to peer communications
Profi bus master
Continuous and sequential control
21 CFR Part 11 auditor
Heat treatment application editor
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