Clean Rooms – Routine Operation and Consumables
20/21 April 2027, Wiesbaden/Germany
Objective
This conference track will introduce you to the expectations of regulatory authorities regarding cleanrooms during operation and provide insight into the requirements for consumables used. Whether single-use or reusable, experienced speakers will present the properties, usability and limitations of various consumables and materials used, such as clothing, cloths, disinfectants, etc., and provide information on their application and use in ongoing operations. In addition, they will share their experiences with self-inspections and dealing with deviations.
Registration
Background
In the manufacture of pharmaceuticals, medical devices, cosmetics or other products with high hygiene and quality requirements, it is not only the ‘big’ investments, such as clean room planning and construction, production line design, ventilation systems, etc., that play an important role. but often the pitfall of quality assurance lies in the ‘small’ materials, often so-called ‘penny items’ that are used many times in daily routine. Gloves to protect products and/or personnel, cloths to clean surfaces, clothing – disposable or reusable – to reduce the risk factor of human contamination, and disinfectants to prevent or reduce contamination.
However, careful selection, qualification and, if necessary, GMP-compliant processing are also of crucial importance for these products and materials. Clear specifications of the materials in terms of their intended use and location are essential. At this point, guidelines such as VDI 2083, Sheet 9.2 or ISO 14644, Sheet 18 may provide users and decision-makers with guidance for their selection and definition processes. Correct application is also important
Target Audience
The conference track is aimed at anyone dealing with the following topics
- Selection and qualification of disposable materials within the framework of quality assurance
- Purchasing and procurement of such materials
- Users of consumables in cleanrooms
- Those responsible for contamination control or contamination control strategy
- Employees of consumables suppliers
- Employees of regulatory authorities
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