Cleanroom trade fair on 23-24 October will provide information on combating microbiological contamination in manufacturing processes
Cleanzone, a two-day international trade fair and congress, will take place on 23-24 October in Frankfurt, Germany, and will provide an overview on the latest cleanroom technology.
According to the organisers of Cleanzone, the biggest challenge for manufacturing processes in the life sciences is microbiological contamination and that bioluminescence-based processes offer the potential to identify airborne microorganisms faster in the future. Yet particulate contamination is also becoming increasingly important to combat.
In cleanrooms in the fields of medicine, pharmaceutical manufacturing and medical technology, it is necessary to satisfy a plethora of requirements, all depending on the particular circumstances.
To prevent the entry of ambient microorganisms, the environment in which manufacturing takes place must be practically free of microorganisms, something that is achieved by the appropriate disinfection of the area, sterile tools and materials, and ventilating the area with air that has been filtered to the maximum possible degree (class A in accordance with EU-GMP).
Personalised medicine can result in even stricter requirements and this year will be one of the top themes at Cleanzone.
In addition to microbiological contamination, particulate contamination is also becoming increasingly important.
Guido Kreck, Fraunhofer Institute for Manufacturing Engineering and Automation (IPA), said: “They are currently a major area of focus in the area of medical technology. If particles enter the bloodstream with an infusion, for example, they can cause thromboses.”
Furthermore, the currently valid version of DIN EN ISO 13485 now mandates that particulate contamination be controlled for sterile medical products.
Kreck: “In recent years this has led to us receiving an increasing number of enquiries here at IPA regarding how to deal with such requirements in actual practice.”
Another example is offered by implants, including dental and hip implants. Their surfaces are roughened to facilitate adhesion to the bone, a process known as osseointegration.
Thanks to the fact that there is close contact with human tissue at the interface between the implant and the bone, it is essential that the product does not have any microbiological, particulate, chemical or film impurities, such as residues of auxiliary substances.
As a result, when manufacturing medical products it is imperative that a suitable and practical cleanliness concept be established, and that this concept account for the production environment (cleanroom, conventional production etc.), cleaning, production process, personnel and logistics.
Visitors to the Cleanzone trade fair will be able to experience all the latest trends in the fields of pharmaceuticals, biotechnology, medicine and medical technology.