Halle 4 – Stability center
Opening times Mo – Fr: 08:00 – 15:30 CET
Email: pme@quasaar.de
Quasaar GmbH • Halle 4 • Lichtenkopfer Weg 1 • D-66450 Bexbach
| ICH conditions | ± 2 °C | ± 5 % RH | Storage volumes |
|---|---|---|
| Zone II | 25 °C | 60 % RH | > 250 m³ |
| Zone III | 30 °C | 35 % RH | 10 m³ |
| Zone IVa | 30 °C | 65 % RH | 10 m³ |
| Zone IVb | 30 °C | 75 % RH | 50 m³ |
| Accelerated | 40 °C | 75 % RH | 100 m³ |
| Refrigerator | 5 °C ± 3 °C | 55 m³ |
| Freeze | -20 °C ± 5 °C | 85 L |
| Storage conditions | Storage volumes |
|---|---|
| 25 ± 2 °C | 40 ± 5 % RH | 750 L |
| 25 ± 2 °C | 75 ± 5 % RH | 750 L |
| 30 ± 2 °C | 92 ± 10 % RH | 750 L |
| 40 ± 2 °C | 25 ± 5 % RH | 750 L |
| 55 ± 2 °C | 50 ± 5 % RH | 10 m³ |
| 60 ± 2 °C | 750 L |
| Controlled substances | 50 m³ (upon demand) |
The climate chambers are qualified in accordance with GMP and DIN ISO standards.
The Quasaar Stability Center offers flexible, large-scale storage solutions, including the capability to store bulky packaging units such as palletized goods and bulk materials. In addition to conducting ICH stability studies, we also support aging studies — for example, on finished medicinal products, active pharmaceutical ingredients (APIs), raw materials/excipients, medical devices, and combined products. In this context, we also offer studies on the tightness and permeability of packaging materials.
We provide refrigerated and frozen storage conditions (5 °C / -20 °C) as well as special storage conditions upon request.
Beyond product storage, Quasaar offers a wide range of additional stability services, including transport validation and logistics support (e.g., transport simulation) in compliance with regulatory requirements. We are capable of performing stress tests under conditions ranging from -20 °C to 150 °C.
The climate control systems are state-of-the-art, qualified according to GMP and DIN ISO standards, and equipped with failure protection. All HVAC units are installed in a redundant configuration. The emergency concept includes access to an external power generator.
How to store your test goods at Quasaar GmbH:
Please let us know your current requirements using the contact form below.
Alternatively, feel free to contact us directly via phone at +49 6826 918962-0 or email at request@quasaar.de
Our team will advise you based on the information provided (including MSDS) and will prepare a study protocol if required.
Based on the information you provide, you will receive a quotation. The project will begin upon confirmation of your order.
Please send your test material and the MSDS to our Stability Center team. We will inspect the shipment and provide you with a receipt confirmation.
We carry out the storage process in accordance with the study protocol and inform you of the start date as well as the corresponding withdrawal time points.
Study procedure:
During the storage study, compliance with the defined parameters is continuously monitored using the MCPS (Multi-Channel Processing System). If required, the corresponding data can be accessed and reported at any time.
At the defined time point, we will inform you about the upcoming withdrawal. On the scheduled day, we remove the samples from the climate chamber or take an aliquot according to your sampling instructions. In case of multiple scheduled samplings, the remaining sample will be returned to storage.
After withdrawal, we either analyze the sample or ship it to you or to a designated responsible unit. Shipping is carried out under pre-defined conditions (e.g. with data logger and 15–25 °C). You will be informed once the sample has been dispatched.
You may also commission us to dispose of any remaining test samples.
Ask us about our individual pricing and rate tables for storage volumes starting at 100 liters. We offer volume-based discounts depending on the reserved storage capacity!
Registration
Delivery
Climatic chamber
Controlled substances
Storage of test samples
Storage of pallets and drums etc.
