Turnkey project for test chambe

Full control in Malaysia

Full control in Malaysia

Weiss Technik has equipped a pharmaceutical manufacturer in Malaysia with two pharmaceutical test chambers. The unusual thing about it: despite the great distance, the testing equipment manufacturer implemented the entire project and handed over the system ready for use. The Southeast Asian company was then able to finish commissioning the system.

The Reiskirchen-based equipment manufacturer supplied two walk-in stability test chambers to a pharmaceutical manufacturer in Malaysia. They were transported to Bangi, a small town in the vicinity of the capital Kuala Lumpur. The town is located almost exactly 10,000 km away from Reiskirchen, Germany. This did not prevent Weiss Technik from being responsible for the entire project as the general contractor - an unusual procedure in the industry. The equipment manufacturer supplied two customised, walk-in PharmaEvent stability test chambers for the climatic tests. In addition, they planned and supervised all subsequent work on the system. This includes construction and electrical work in the testing laboratory, the installation of safety systems, the climate system and the work tables and shelving systems for the testing laboratory.

In the climatic chambers, the resistance of medicines is tested under influences such as heat, cold and high humidity. Manufacturers need these chambers to test their product range according to GMP and FDA guidelines. The company now uses the chambers for its entire portfolio. These include medicines in solid, granular and liquid form as well as creams and injectable solutions.

To ensure high reliability, each test chamber is equipped with a redundant cooling system. The monitoring software of the test chambers complies with the FDA requirements for electronic records (FDA 21 CFR Part 11). Weiss Technik was able to complete all construction measures, the complete installation and the qualification (IQ, OQ, DQ, PQ) in only four months - faster than planned. The Malaysian pharmaceutical manufacturer now has a state-of-the-art facility for quality assurance in line with requirements.