Stability studies

The Quasaar Stability Centre offers flexible and large-volume storage facilities, which also allow the storage of voluminous packaging units (pallets) up to bulk goods.

In addition to conducting ICH studies, it is also possible to place ageing studies, e.g. of medical devices. In this context, leakage and permation studies of packaging materials can also be carried out. 600 cubic metres of ICH-climate are already available.

Cold and frozen storage (5 °C/-20 °C) and special conditions can be implemented on request. In terms of location, expansion options from 50 to 500 cubic metres can be implemented at short notice (lead time approx. 8-12 weeks).

The air conditioning systems are state-of-the-art and qualified in accordance with GMP and DIN-ISO requirements, as well as equipped with failure protection. The air conditioning units are redundant. The emergency concept includes access to an external generator. In the medium term, this will be replaced by a combination of photovaltics/battery storage.
By using an RFID-coupled control unit, in the medium term it will be possible to implement an enormous optimisation of quality and efficiency.

 

Climate and storage volume

StabikammerPME

The following ICH climates and storage volumes are available:

25 °C/60 % r. h. 280 m3

30 °C/75 % r. h. 150 m3

40 °C/75 % r. h. 50 - 80 m3

30 °C/65 % r. h. 0,5 m3- 15 m3

50 °C/30 % r. h. 0,5 m3- 15 m3

50 °C /60 °C 1 m3 - 15 m3

 

BTM-storage possible!

 

Cold and frozen storage

-20 °C ± 5 °C

5 °C ± 3 °C

 

Special conditions (on request)

25 °C/40 % r. h.

40 °C/25 % r. h.

30 °C/35 % r. h.

 

Technical data:

Temperature and humidity control in redundant design

Overtemperature and moisture protection

Monitoring system: Yokogawa

Alarm message: SMS, e-mail

 

In addition to the original storage of products, Quasaar offers other stability services such as transport validation and transport logistics (including transport validation) for its products in compliance with regulatory requirements.

Transport simulation studies / transport validation (simulation of transport route, qualification of packaging materials)

Performance of stress tests (range: -20°C to 150°C)

Conception and implementation of forced degradation studies

Stress stability to prove the stability indicative properties of analytical methods

Further services:

preparation of stability plans and reports (summary reports)

Shelf life of standard substances and reagents

Please also ask us for our individual conditions and price tables for storage >0.5 m3. We offer you discounts up to storage volumes of 50 m3