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 Should Attend:
- 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
Course Director: KIERSTAN ANDRASCIK
Kierstan Andrascik, founder of QVET Consulting, with her years of experience in the medical device industry assists manufacturers with their validation needs. She specializes in cleaning validations for both new and reprocessed medical devices and has established herself as one of the foremost experts in medical device cleanliness. She also provides guidance in many other areas including sterilization, biocompatibility, packaging, and materials characterization. Previously, she worked at Nelson Laboratories in Salt Lake City, Utah where she served as study director covering a variety of testing including new device cleaning validations, materials characterization, and package testing.
In 2002, she began developing a method to quantify residual manufacturing materials on medical devices. In 2005, ASTM published a similar method as F2459. Kierstan has been actively serving on the ASTM Device Cleanliness subcommittee since 2005. She received a Certificate of Achievement from ASTM in May 2007. In the June 2008 issue of Medical Design magazine, her article titled “How to tell if a device is really clean” was published. Then, in April 2011, her chapter Cleaning Validations using Extraction Techniques published in the 2nd edition of Handbook for Critical Cleaning. She has a BS in chemistry and mathematics, and an AS in Engineering from Shepherd University in Shepherdstown, West Virginia.