Stability testing for product validation

Stability testing

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.

Read our page dedicated to material test chamber!

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

ICH Q1A stability testing

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

CFR-21 software

CFR-21 Controller:

  • Colour touchscreen display
  • Peer to peer communications
  • Modbus master/slave
  • Profi bus master
  • 10/100Mbps Ethernet
  • Continuous and sequential control
  • Multi-setpoint programmer
  • Batch control
  • Recipes
  • USB support
  • 21 CFR Part 11 auditor
  • Data logging
  • Open communications
  • Alarm management
  • Multi-language support
  • Heat treatment application editor

 

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