Competence and Progress

Whether we are dealing with pharmaceutical products or medical devices, we must always consciously focus on the safety of the public using these products. This mission constantly throws up new challenges that can only be met if we maintain our scientific competence and continue to develop our methods.

Following the relocation of BioChem to a new building in 1988, the chemical and microbiological analytical laboratories – a key sector within BioChem – were established on the 3rd floor and quickly ensured that the most important pharmaceutical microbiological test procedures were immediately up and running. The range of test procedures on offer has been continually extended.

A Complete Range

In the meantime, the Microbiology Department is able to provide a complete program of test procedures, as required by GMP, GLP and other requirements according to the relevant current pharmacopoeia methods. In addition, we also offer hygiene testing of client facilities. This service grew from our response to client requests, sometimes for a specific test or sometimes for a complete review, using our own staff to collect samples in the client’s facilities. Nonroutine tests may be carried out in and around production facilities, e. g. validation of sterilization processes. Together with molecular biological methods, we are thus able to offer a comprehensive service program.

A Growing Customer Base

The high quality standard of all our laboratories has led to the steady growth of our customer base. As a result, we finally outgrew our available space and also needed to increase the capacity of our equipment. This led to the decision to expand the Microbiology Department and to relocate to a different wing. While planning the new laboratories, we were very concerned to minimize the risk of cross contamination by carefully controlling material handling throughout. Each room was fitted with especially designed furniture that would facilitate optimal cleaning and disinfection. The original existing equipment was complemented by eight laminar-flow workstations, a special cytostatics workstation, eight incubators, three steam sterilizes and a high-purity water plant.

A New Microbiological Laboratory Complex

The move to the new facilities was completed in February 2005. The Microbiology Department is now established in a state-of-the-art, fully air-conditioned laboratory with an area of about 500 m2 floor space. We have individual laboratory units for specific tests, e. g. testing for bacterial endotoxins and microbiological assays of antibiotics. In the latter case we are able to use a special instrument to measure the growth-inhibition zones. This instrument was constructed in close cooperation with BioChem to incorporate our experience in this field. Larger laboratory units are also available e. g. for total viable aerobic count and tests for specific microorganisms. Both the evaluation of tests, as well as the identification of cultures, are carried out in a central facility, physically separated from the initial processing before incubation. One laboratory unit, complete with a reference library of microorganisms is reserved exclusively for all validation studies. For sterility tests, a separate laboratory unit has been established containing its own isolator. The Microbiology Department now has at its disposal separate rooms for the preparation of culture media, sterilization of waste with washing-up. In addition, there are two walk-in incubation chambers and a cold storage room.

Outsourcing Potential for Clients

Thanks to the new microbiology facilities, BioChem is able to offer clients a state-of-the-art GMP-validated, generously conceived laboratory complex with extended capacity for all microbiological tests. Thus we are also confident, that we can accommodate any additional requirements the authorities may see fit to mandate in the future.

Competence through Experience

The Microbiology Department, would not be so effective, were it not for the long-serving experienced staff, who are responsible for the prompt completion of your commissions in accordance with GMP. We are proud of our flexibility and readiness to respond to our client’s microbiological requirements, whatever they may be.