Purity of medical devices in the manufacturing process

Reinheitsprüfung eines Medizinprodukts

Flowchart for the assessment and determination of purity requirements of medical devices according to VDI 2083 Sheet 21.

Contents of the New Guideline

The guideline VDI 2083 Sheet 21 provides overarching guidance on the topic of cleanliness of medical devices in the manufacturing process and thus forms a basis in the absence of product-specific regulations. The guideline describes the procedure for deciding the necessity of acceptance criteria for critical contaminants based on a risk-based approach.

A strategy for establishing acceptance criteria is described, which can result from different necessities (e.g., medical or technical).

Furthermore, information is provided on selecting suitable testing methods, distinguishing between different purposes of use, e.g., cleaning validation and root cause analysis, as different requirements are associated with each application. Biological, chemical, and particulate contaminants are differentiated.

For particulate contaminants, a generally applicable procedure for extraction and verification, as well as a convention for automated evaluation with a microscope system, is described for the first time.

The described approach, from setting acceptance criteria to deriving an appropriate testing strategy, is illustrated with case examples.

Event for the Presentation of the New Guideline on 24.01.2019

The new guideline VDI 2083 Sheet 21 will be introduced comprehensively and specifically at an information event at the Fraunhofer IPA in Stuttgart for the first time.

Topics of the Event:

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

Goals of the Event

The new Sheet 21 of the VDI 2083 guideline series will include information on a generally valid and overarching standard for the cleanliness of medical devices in the manufacturing process. In this event, manufacturers of medical devices as well as other stakeholders will gain an initial comprehensive insight into the background, content, and handling of the new guideline. Participants will learn a structured approach to identify which questions need to be addressed to decide whether acceptance criteria for product cleanliness are necessary and, if so, what they could look like. Additionally, suitable and meaningful analysis methods for different types of contaminants (biological, chemical, or particulate) will be presented.

Target Audience

- Manufacturers of medical devices: specialists and managers involved in the approval process as well as in development, production, and quality assurance dealing with the topic of product cleanliness.
- Notified bodies