Purity of medical devices in the manufacturing process

For the first time, the white paper of guideline VDI 2083 Sheet 21 is comprehensively and topic-specifically presented within the framework of an informational event.

The aim of the event is to present the new and immediately available overarching guidelines concerning the purity of medical products in the manufacturing process through practical case examples. The procedure for deciding the necessity of acceptance criteria for critical contaminants based on a risk-based approach will be examined.

Additionally, a strategy for establishing acceptance criteria will be described, along with information on selecting testing methods. A distinction is made between biological, chemical, and particulate contaminants. Particularly for particulate contaminants, a detailed description including a validation approach is provided, enabling the transferability of the method to different medical products.

Topics of the Conference:

- Procedure for deriving acceptance criteria
- Selection of suitable and reliable analytical methods
- Application of the guideline using case examples

Objectives of the Conference:

The new Sheet 21 of the VDI 2083 guideline series will include information on a generally applicable and overarching standard for the purity of medical products in the manufacturing process. In this conference, medical device manufacturers will gain their first comprehensive insight into the background, content, and handling of the new guideline.

Participants will learn a structured approach to determine which questions need to be addressed to decide whether acceptance criteria for product purity are necessary and, if so, what they might look like. Furthermore, suitable and reliable analytical methods for different types of contaminants (biological, chemical, or particulate) will be presented.

Target Audience:

Manufacturers of medical devices: professionals and managers involved in the approval process as well as in development, production, and quality assurance, who are confronted with the topic of product purity.