Cleanliness in Life Sciences

In life science branches such as the medical engineering and biotechnology industry or pharmaceutical industry, by tradition the concept of cleanliness is strongly anchored in production processes. The presence of particles capable of reproduction (microorganisms) has always been considered to be especially critical to product quality and patient health. Germs can settle in corners and dead spaces where they start to multiply. In the course of production processes, these microorganisms find a way into the product flow (cross-contamination) and cause an infection. It is essential that the manufacturing environment (cleanroom) is not a source of microorganisms. To ensure this, devices, equipment and components have to be designed appropriately. Additionally, by selecting materials that are easy to clean, interactions between materials and microorganisms can be avoided.

On the initiative of the various industries concerned, developments are currently being focused 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.


Services:

  • Compiling expert reports to confirm and document the suitability of operating materials for use in clean manufacturing environments under consideration of the relevant guidelines and regulations on manufacturing under clean conditions (GMP, HACCP, EHEDG), e.g. with regard to hygienic design
  • Materials testing to assess cleanability, microbiological effects of material surfaces (sterilization kinetics), ability to resist metabolism and also resistance to chemicals
  • Airflow visualization to depict airflow patterns around a device or piece of equipment and in the direct surroundings (avoidance of spontaneous contamination)
  • Filter leakage tests, determination of filtration efficiency of the ability of filters to retain microorganisms
  • Cleanroom inspections to determine airborne microbial concentrations and surfaces microorganism counts



For some time now, a re-think has been taking place in life science industries. It is becoming increasingly clear that it is not just germs that are capable of reproduction or fragments of pyrogenic substances which represent a risk to quality and health but also abiotic particles and filmy residues, e.g. from manufacturing processes. Our longstanding experience in many other areas of industry where contamination is an issue 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, ionic and filmy residues
  • Planning and optimization of clean manufacturing areas and equipment
  • Determination of particulate emission from materials or outgassing of volatile substances