Ensuring process and product safety in medical technology

Medical technology products that come into contact with the human body must exhibit a defined level of cleanliness up to sterilization. Reproducible processes for cleaning and cleanliness control are required for this. The appropriate solutions are presented at the 4th specialist conference on component and surface cleaning in medical technology, tailored to the requirements of manufacturing medical devices. The event organized by fairXperts will take place on November 17 and 18, 2015, at the K3N in Nuremtingen.

The term cleanliness in medical technology is primarily associated with sterilization. However, the removal of contaminants from component manufacturing—such as machining media, release agents, particles, burrs, and dust—is increasingly important. Accordingly, component and surface cleaning in the production of medical devices is gaining more focus. The goal of the cleaning processes is to reduce particulate and chemical contamination, microbiological impurities, and other contaminants to meet normative and legal requirements for medical devices. To ensure process and product safety, controlling the particulate and film cleanliness achieved during cleaning through suitable measurement and analytical methods is indispensable. The 4th specialist conference on component and surface cleaning in medical technology presents solutions for these tasks. It is organized by fairXperts GmbH & Co. KG and will be held on November 17 and 18, 2015, at the Kultur- und Tagungszentrum K3N in Nuremtingen.

Practical knowledge on cleaning and cleanliness control

The two-day event is divided into three thematic blocks: "Regulatory," "Cleaning," and "Evaluation of Cleaning Results," with a total of 13 presentations.

The first session covers, among other topics, the development of a normative framework for the cleanliness of medical devices. Existing normative guidelines are discussed, as well as the draft of ISO 19227, which includes categorizing analytical methods and acceptance criteria. Another presentation in this series deals with the details that must be considered during the planning phase of a validated cleaning process and introduces an appropriate approach.

An overview of the cleaning procedures used in medical technology is provided by the second thematic block. This is followed by a discussion of the principle of cyclic nucleation, a proven process engineering solution for cleaning components and parts with capillary structures, such as complex or non-exposed 3D shapes with deep cavities and bores with small cross-sections. The laser beam cleaning technology and its application possibilities are presented. New load carriers and logistics solutions for "clean" manufacturing of medical products with minimal scrap rates and short throughput times are also on the agenda. The monitoring of cleaning processes using laser-induced, time-integrating fluorescence spectroscopy LIF(t) through control on the component is also discussed.

The third session begins with a presentation on VIDAM (Vacuum-Induced Desorption Analysis Measurement Device), a solution for detecting and identifying residual film contamination on medical devices. Organic residual contamination is the topic of another presentation, which introduces analytical methods such as GC-MS, GC-FID, HPLC, or IR for their detection and characterization. Participants will also learn about methods for determining technical cleanliness through the combination of optical and spectroscopic analysis techniques. Additionally, an attractive biomedical method is discussed, where blood serves as a biological sensor.

Alongside the conference, an accompanying exhibition will showcase products and services for cleaning and cleanliness control in medical technology.

The event is aimed at technical and managerial staff from manufacturing, quality assurance, production planning, design, and development of medical device manufacturers and their suppliers.

Further information and the full program of the 4th specialist conference on component and surface cleaning in medical technology can be accessed at http://www.fairxperts.de/xpert-conferences/.