Turnkey project for testing chamber

Weiss Technik has equipped a pharmaceutical manufacturer in Malaysia with two pharmaceutical test chambers. The unusual aspect: despite the great distance, the test system manufacturer carried out the entire project and handed over the plant turnkey. The Southeast Asian company was able to put the system into operation fully.

The plant manufacturer from Reiskirchen delivered two walk-in stability test chambers to a pharmaceutical manufacturer in Malaysia. The transport took place to Bangi, a small town near the capital Kuala Lumpur. This location is almost exactly 10,000 km from Reiskirchen, Germany. This did not prevent Weiss Technik from taking responsibility as the general contractor for the entire project – an uncommon process in the industry. The system builder supplied two custom-made, walk-in PharmaEvent stability test chambers for climate testing. In addition, he planned and supervised all other work on the plant. This includes construction and electrical work in the test laboratory, the installation of safety systems, the air conditioning, as well as workbenches and shelving systems for the test laboratory.

The climate chambers are used to test the stability of medicines under influences such as heat, cold, and high humidity. The manufacturer needs these chambers to test its product range according to GMP and FDA guidelines. The company now uses the chambers for its entire portfolio. This includes medicines in solid, granular, and liquid forms, as well as creams and injection solutions.

To ensure high reliability, the test chambers are each equipped with a redundant cooling system. The monitoring software of the test chambers complies with FDA requirements for electronic records (FDA 21 CFR Part 11). All construction work, the complete installation, and qualification (IQ, OQ, DQ, PQ) were completed by Weiss Technik in only four months – faster than planned. The Malaysian pharmaceutical manufacturer now has a state-of-the-art facility for compliant quality assurance.