Test cabinet manufacturer BINDER (www.binder-world.com) and pharmaceuticals supplier Diapharm (www.diapharm.de) are working on improving and simplifying GMP-conforming qualification of climatic exposure test cabinets. Practical aids for the design and operational qualification of these devices are in the planning stage. Since starting on-going stability tests subject to the European GMP Guideline, the climatic exposure test cabinets in pharmaceutical laboratories are GMP-relevant equipment. "Therefore, the qualification of these devices has become an important topic in regulatory inspections," states Diapharm CEO Dr. Sven Oliver Kruse.
"As a premium supplier we support our customers with installation in accordance with the standards and with the operation of our test cabinets", says Axel Schuler, director of product management and marketing at BINDER. "The practical experience that Diapharm has from everyday laboratory work helps us improve our support and also to maintain a continuous improvement program for the product." Together with Diapharm Axel Schuler is interested in assisting pharmaceutical laboratories to meet regulatory requirements as efficiently as possible. Guidelines for tasks such as mapping, the confirmation of homogenous temperature and humidity distributions, are planned. Extended logger functions for recording measurement data over long periods are also in the planning stage.
A workshop presented by Diapharm CEO Dr. Sven Oliver Kruse on the topic of "GMP-conforming on-going stability testing" to external and internal employees of BINDER on May 26 in Tuttlingen was the start of the cooperation between the testing cabinet manufacturer and users. Diapharm has been successfully using BINDER constant climatic cabinets in their own service laboratory in Oldenburg for stability testing of drugs for years.