Cleaning Validations Using Extraction Techniques

Description :

Medical device manufacturers have always been under scrutiny to ensure that their product does no harm to the patient. Regulatory agencies have become increasingly aware of the potential dangers of residual manufacturing materials on medical devices. Therefore, cleanliness has become a hot topic in the medical device community. A thorough validation of the cleaning processes used to remove residual materials from newly manufactured medical devices is necessary to ensure patient safety. One of the most common methods is using extraction techniques to validate the cleanliness of a device.

This 60 minutes webinar will provide in-depth and valuable guidance on how to achieve a thorough validation of a cleaning process.

Areas Covered in the Session :

Cleaning Validation Overview

Defining the Scope

Identifying the Contaminants

Choosing the Test Method

Choosing the Solvents

Setting Extraction Parameters

Validating the Extraction

Setting Limits

Who Will Benefit:

QA/QC managers and personnel

Validation managers and personnel

Manufacturers of Implantable Medical Devices

Manufacturers of Single-Use Medical Devices

Manufacturers of Reprocessed/Reusable Medical Devices