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Tel: +49 341 25279910 Fax: +49 341 25279911 info-leipzig@profusio.de www.zytoservice.deContact person
Martin PoppOffer
Individual, precisely customised parenteral medicinal preparations are one of the most important ways for treating patients with chronic illnesses. Our experts prepare these formulations with the same care taken for industrial preparations: in a clean room environment and in accordance with the highest GMP standards, Clean room Class A.
All pressure zones are constantly monitored in order to maintain stable clean room conditions at all times. Microbiological monitoring of our clean room zones and products is also standard - always performed using state-of-the-art technology and methods and accompanied by complete documentation.
Underlying this all is a tiered clean room system with a compounding in Class A, Class B manufacturing environment, preceded by Classes C and D and the appropriate personnel and material locks. Reaction time, security and thoroughness are just as essential as strong products and services – as well as a comprehensive approach towards the safety and protection of our products, personnel and the environment.
At Oncosachs, product safety means: Control of incoming goods, in-process controls, finished product control and a three-step, qualified release. Thus, we possess the manufacturing authorisation pursuant to Section 13 AMG (German Drug Law). Comprehensive protocols for documentation and hygiene complete the picture.