Case study SGS Analytics Switzerland AG

What is the shelf life of drugs?

Drug manufacturers must specify an expiration date for their products as part of the approval process. This expiration date cannot be calculated. It must be determined based on experiments as part of stability studies like those SGS Analytics conducts on behalf of its customers.  And this is where BINDER constant climate chambers come into play. They are used to store drugs under predefined climatic conditions (temperature and humidity). The storage conditions are defined in guidelines from the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) and must be strictly adhered to. 

The number of samples in the studies varies, and drugs are stored for a period of up to five years. A detailed study plan defines when measurements are taken. “An initial measurement we call the T0 measurement is usually taken before we put the samples into storage,” explains Bernhard Schnurr, Site Manager at SGS Analytics. “This is followed by subsequent measurements T1, T2, T3, etc., which are usually taken every few months as set out in the study plan.” At the times set for the measurements, the samples are taken out of the cabinet and analyzed based on predefined criteria. The products must meet the predefined criteria. If they fail to do this, the samples concerned might no longer be stable.  The corresponding data and results are used to determine shelf life. 

Reliable continuous operation: Constant climate chambers from BINDER

The constant climate chambers used for ICH stability testing must be capable of smooth operation without errors over prolonged periods of time. If, for example, a drug approval had to be aborted due to a technical defect affecting the climate chamber, this would have catastrophic consequences for both the manufacturer and SGS Analytics. This is why the company has chosen constant climate chambers from BINDER to deliver reliable continuous operation. “Reliability is a major consideration for us,” says Bernhard Schnurr. “I don’t want a unit to fail or an alarm to sound. I have been working with BINDER units for many years and things have always gone well. I’ve never had a problem with BINDER chambers.” Sustainability was also a factor in choosing the climate chambers. Thanks to thermoelectric cooling technology, BINDER’s KBF-S ECO constant climate chamber is very energy-efficient and operates without refrigerants. The chamber’s technical data are as impressive as its compact dimensions.

Easy to clean and straightforward to operate 

Alongside reliability, the straightforward operation of the BINDER climate chamber is appreciated by the employees at SGS. “Operation is self-explanatory, and our team in the laboratory is able to get to grips with everything easily,” confirms Bernhard Schnurr. When working with the climate chamber on a daily basis, it is often the little things that help to make life easy. The doors are always easy to open and close, for example, which is important when working in a laboratory setting. The shelves inside the chamber can be rearranged to meet individual requirements. The units are easy to move around and even relocate to other rooms, as they are mounted on efficient, smooth-running casters. 

Cleaning is another important consideration, as everything must always be clean in a laboratory. BINDER climate chambers have sufficient ground clearance to make cleaning underneath the unit easy.