+49 (0) 6471 / 6293-0

info@ttwe.de

product enquiry

Stability testing

Especially for stability testing according to ICH guideline and GMP

At the Weilburg site, there are three walk-in climatic chambers, each with space for up to 30 Euro pallets, as well as climatic chambers with a useful volume of up to 1750 liters. All our units are calibrated and qualified. They cover all common climates according to ICH-Guideline and can also be converted and qualified for “special climates” – please contact us if you have any questions.

Climate chamber 1

Due to our many years of experience in the pharmaceutical industry, we are familiar with the high requirements according to GMP. Our climate chambers are equipped with a self-sufficient data acquisition system and are regularly maintained and calibrated.

In addition, our climatic chambers are characterized by their efficient operation coupled with a very homogeneous air distribution. When designing our facilities, we have focused our attention on very high energy efficiency. For example, ultrasonic humidifiers are used for most operating points and a separate coil is used for dehumidification in the air-calming room. In addition, a steam humidifier is equally available for higher climate requirements.

Should a climatic chamber ever have a malfunction / error, our service technicians are available 24/7.

All in all, we can thus offer our customers maximum safety and reliability.

The following storage volumes are currently available, but can also be expanded according to customer specifications with a lead time of approx. 10 weeks:

Climatic chamber 1: 70 m³; approx. 30 pallet spaces

Climatic chamber 2: 35 m³; approx. 15 pallet spaces

Climatic chamber 3: 15 m³; approx. 10 pallet spaces

Our climate chambers are all designed for a wide range of temperatures and humidity. The following ICH climates are covered:

25°C / 60 % r. H.

30°C / 65% r. H.

30°C / 75 % r. H.

40°C / 75 % r. H.

40°C / 20 % r. H.

30°C / 35% r. H.

Our climate chambers are also available for accelerated aging (according to ASTM F1980) and for conditioning containers, packaging or packaging components (according to ASTM D4332). For example, the following conditions and many other operating points can be covered:

55°C / 25 % r. H.

50°C / 30 % r. H.

45°C / 35 % r. H.

40°C / 45 % r. H

Do you need any further help?
We will be happy to advise you!

Oliver Kassl

Laboratory Manager

Tel.: +49 (0) 6471-6293-231

Dirk Hermann

Deputy Laboratory Manager

Tel.: +49 (0) 6471-6293-136