For the sterile/aseptic production of medicinal products in clean rooms belonging to pharmacies or pharmacy-like manufacturers, a large number of standards, guidelines and laws must be complied with: EG GMP Annex 1, DIN EN ISO 14644 and 17141, VDI Guideline 2083, ApBetrO as well as the guidelines of the ADKA and the BAK.

For manufacturers who work according to or close to the guidelines of good manufacturing practice (GMP), the much-discussed update of Annex 1, gives them a particular challenge: among other things, it formulates very clear requirements and specifications with regard to hygiene monitoring of clean rooms, the implementation of which often lacks the necessary capacity and in-house know-how.

As a GMP-certified quality control laboratory, BioChem Labor für biologische und chemische Analytik GmbH offers a wide range of consulting and laboratory services in the field of hygiene monitoring and microbiology that are specifically aimed to the needs of manufacturing companies. In this way, BioChem supports manufacturers in their goal of ensuring the highest level of product and patient safety.

A microbiological hygiene monitoring concept ensures that pharmaceutical preparations are manufactured under controlled conditions. It includes monitoring of the air, the process water used, the surfaces and the personnel. BioChem provides support in this area, e.g. by:

• Consulting on the development of a hygiene concept for clean rooms in terms of: clothing, cleaning, monitoring, personnel monitoring, process simulation/media fill
• Consulting in clean room qualification
• Preparation of qualification documents: IQ │ OQ │PQ as well as risk analyses to determine monitoring points
• Practical implementation of microbiological qualification incl. incubation, evaluation and report
• Incubation and evaluation of samples from routine hygiene monitoring
• Identification of bacteria, yeasts and fungi morphologically/microscopically, by mass spectrometry (MALDI TOF) or by molecular biological methods
• Microbial environmental monitoring in the manufacturing plant (airborne germ collection and taking of surface swab samples in the clean room on site)

The entire consultation and documentation is precisely adapted to the local circumstances and the consultation is individually tailored to the needs on site.