Stability studies

Choose the right partner for your product storage and stability studies.

With 35 years’ experience, Quality Assistance offers the tools and experience to store and analyse your API and drug product stability at different steps of their development, in a GMP and GLP environment and in ICH conditions.

We are able to support you on the long term for stability studies related to clinical trials application, product licence application and post-approval monitoring.

Our laboratories and facilities are all located on one site for more efficiency.

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Stability studies

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Storage for all matrices

Stability storage

  • 150 m³ capacity, 7 walk-in chambers
  • Cabinets, refrigerators, freezers including ultralow temperature, liquid nitrogen vapour phase
  • All ICH conditions available
  • Customised conditions for specific requests

 

Quality Assurance

  • Full compliance with cGMP (FDA inspected)

  • Computerised sample flow management

  • 24/7 computerised monitoring of conditions

  • Back-up storage facilities

  • Back-up electricity generators

  • In-house maintenance and qualification teams

  • Secure site (restricted access, alarm systems, etc.)

ICH conditions

Other conditions

Ultra-low conditions

-20°C ± 5°C

-30°C ± 5°C

- 60°C ± 10°C

5°C ± 3°C

15 ± 2°C

- 70°C ± 10°C

25 ± 2°C / 40 ± 5% RH

20 ± 2°C

Vapour phase nitrogen (-196°C)

25 ± 2°C / 60 ± 5% RH

30°C / <40% RH

 

30 ± 2°C / 65 ± 5% RH

50°C / <40% RH

 

40 ± 2°C / not greater than 25% RH

60 °C / <40% RH

 

40 ± 2°C / 75 ± 5% RH

22,5 ± 2,5°C / 1000 lux ± 400 lux

 

30 ± 2°C / 35 ± 5% RH

-5° C ± 2° C

 

30 ± 2°C / 75 ± 5% RH