Turnkey Cleanroom Class "A" in Germany with isolator technology

Turnkey example D-room

With the amendment of the Pharmacy Operating Regulations (ApBetrO), the rules for aseptic manufacturing have been tightened. Renovations, upgrades of existing cleanrooms, or even the construction of a new laboratory are the consequences. However, renovation or new construction involves not only costs but also significant planning efforts, inspection of the execution quality of individual trades, cleanroom qualification, and regulatory approval and acceptance.

Here, the companies Berner International and Weiss Klimatechnik offer professional support.

For more than 30 years, Berner International has been recognized as an expert in highly demanding safety systems in laboratories, such as safety cabinets and isolators, with the quality seal "Made in Germany" as well as personal protection through tested and certified personal protective equipment.

Weiss Klimatechnik has been representing innovative developments and high quality in cleanroom and climate technology worldwide for many decades. Wherever optimal climatic conditions are required for production processes and procedures, for people and machines, Weiss air conditioning units and systems have proven their worth.

The partners now jointly offer, with the new product "Turnkey" (English for turnkey), a production-ready cleanroom of GMP class "D" including an isolator for the manufacturing of, for example, parenterals, CMR drugs, etc. All phases from planning through execution, equipment, qualification, regulatory approval, and acceptance are supported by the experts of both companies. After an on-site inspection and a coordination of all requirements and wishes, the customer receives a fixed price. This protects the customer from the risk of price increases during the construction phase, which are common in projects of this kind.

Even after completion, the two companies offer professional support with nationwide service concepts. Upon request, plant remote monitoring with 24/7 availability is possible within the framework of service level agreements for cleanroom technology.