Stability/Ageing Studies

The Quasaar stability center offers flexible and large-volume storage options, which also enable the storage of voluminous packing units (pallets) up to bulk goods. In addition to conducting ICH studies, it is also possible to place ageing studies, for example of medical devices. In this context, tightness and permeation studies of packing material can also be realized. 600 cubic meters of ICH climates are already available.

Refrigerated and frozen storage (5 ° C / -20 ° C) as well as special conditions can be implemented on request. In terms of location, extension options of 601 to 2500 cubic meters can be implemented in the medium term (lead time approx. 8-12 weeks).

The climatic rooms are state-of-the-art and qualified in accordance with GMP and DIN-ISO requirements and equipped with fail-safe 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 Photovaltik / battery storage.

By using an RFID-coupled control unit, an enormous optimization of quality as well as efficiency can be realized in the medium term.

 

Further services:

- Storage of small biologicals (on request)

- Stress stabilities to prove the stability-indicating properties of analytical methods

- Durability of standard substances and reagents

- Preparation of stability plans and reports (Summary reports)

Climatic Condition & Storage Volumes

The following ICH climates and storage volumes are available:

 

25 ° C / 60% r. F. 280 m3

30 ° C / 75% r. F. 180 m3

40 ° C / 75% r. F. 50-80 m3

30 ° C / 65% r. F. 0.5 m3-15 m3

50 ° C / 60 ° C 1 m3 - 15 m3

 

new climatic condition: 55°C / 22 % r.F., storage of controlled substances possible!

 

Refrigerated and frozen storage

 

-20 ° C ± 5 ° C

5 ° C ± 3 ° C

 

Special conditions (on request)

 

25 ° C / 40% r. F.

40 ° C / 25% r. F.

30 ° C / 35% r. F.

 

Technical specifications:

 

Temperature and humidity control in redundant design

Overtemperature and humidity protection

Monitoring system Yokogawa

Alarm message SMS, e-mail

 

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

Transport simulation studies / transport validation

Carrying out stress tests (Range: -20 ° C to 150 ° C)

In addition to the quantitative optimization of storage facilities, Quasaar also aims to improve the quality of its processes. The use of RFID technology is currently being tested. The goal is to increase automation of the process, minimize the human error factor and minimize manual data check activities.

Ask us for our individual conditions and price tables for storages> 10 m3.