Cleanrooms - Routine Operations and Consumables

Objective

This conference track will provide an overview of the expectations of regulatory authorities regarding cleanrooms during operation, as well as an insight into the requirements for consumables used. 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. Furthermore, they will share their experiences with self-inspections and dealing with deviations.

Background

In the manufacture of pharmaceuticals, medical devices, cosmetics and other products with high hygiene and quality requirements, it is not only the significant investments, such as clean room planning and construction, production line design and ventilation systems, that play an important role. The quality assurance process also relies on the smaller materials, often referred to as 'penny items', that are used repeatedly in daily routines. 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.

Nevertheless, it is imperative to exercise meticulous selection, qualification, and if deemed necessary, GMP-compliant processing 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 a framework for the 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 single-use materials within quality assurance
• Purchasing and procurement of such materials
• Users of consumables in cleanrooms
• Personnel responsible for contamination control or contamination control strategies
• Employees of suppliers of consumable materials
• Staff from regulatory authorities

 

You can find more detailed information at a later time.