Cleanliness in Life Sciences

In life science branches, such as medical engineering, biotechnology industry and pharmaceutical industry, the concept of cleanliness is strongly anchored by tradition in production processes. The presence of microorganisms capable of reproducing has always been considered to be especially critical to product quality and patient health. Germs can accumulate in corners and dead spaces where they start to multiply. In the course of production processes, these microorganisms find a way into the product stream and cause an infection. Therefore, devices, equipment and components have to be conceived to prevent cross-contamination, for example through appropriate design and layout. Additionally, interactions between materials and microorganisms can be avoided by selecting materials that are easy to clean. The manufacturing environment or cleanroom may not be a breeding ground for microorganisms.

On the initiative of the various industries concerned, a current focus of development is on drafting a guideline to regulate the cleanliness of medical products. The guideline will contain methods for deriving acceptance criteria as well as reliable, standardized analysis procedures.

Our services:

• Compiling expert reports to confirm and document the suitability of operating utilities for use in clean manufacturing environments in compliance with the relevant guidelines and regulations on manufacturing under clean conditions (GMP, HACCP, EHEDG), e.g. with regard to hygienic design
• Material tests, e.g. to assess cleanability, the microbiological effects of material surfaces (sterilization kinetics), the ability to resist metabolism, resistance to chemicals
• Airflow visualization to depict airflow patterns around a device or piece of equipment and in its immediate surroundings (prevention of spontaneous contamination)
• Filter leakage tests, filtration efficiency tests and determination of the ability of filters to retain microorganisms
• Cleanroom inspections to ascertain the concentration of airborne microbes and determine the presence of microorganisms on surfaces

For some time now, a re-think has been taking place in life science industries. It is becoming increasingly clear that it’s not just germs capable of reproduction or fragments of pyrogenic substances that represent a quality or health risk but also abiotic particles and filmy residues, e.g. from manufacturing processes. Our longstanding experience in many other areas of industry concerned with contamination enables us to offer a wide range of services to analyze and control these risks:

• Determination of particulate emission from devices and equipment in order to classify cleanroom suitability (»Fraunhofer TESTED DEVICE®«)
• Validation of cleaning processes for removing contamination such as particles and ionic or filmy residues
• Planning and optimization of clean manufacturing areas and equipment
• Determination of particulate emission or outgassing of volatile substances from materials