Cleaning Validations Using Extraction Techniques

Cleaning validations are an essential step in the medical device development process. One of the most common methods is using extraction techniques to validate the cleanliness of a device. This webinar will provide valuable guidance on how to achieve a thorough validation of a cleaning process.

Why should you attend: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.

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

Speaker Profile

Kierstan Andrascik has worked in the medical device industry for more than 12 years. She founded QVET Consulting in 2009 to assist medical device 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.

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Quality by Design (QBD) and analytical methods

Quality by Design (QBD) and analytical methods have come into focus because of an inherent limitation in the guideline used for validation of analytical methods. The International Conference on Harmonization (ICH)’s Q2 guideline, Validation of Analytical Procedures: Text and Methodology serves as the guiding document for validation of analytical methods for pharmaceutical products. Since the most common approach to method validation is a one-time affair, there is need for guidance on how to implement continuous and consistent method performance.

Methods fail to perform as required or intended in the receiving laboratory because there is always the absence of an effective process for capturing and transferring the knowledge of those involved in the development. With too much emphasis on validation of the methods to meet regulatory requirements, the focus on what to do to make the process work during actual application seemed to be lost. It is to address this bottleneck that Quality by Design (QBD) and analytical methods took shape.

How do Quality by Design (QBD) and analytical methods make a difference?

QBD, in being “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding based on sound science and quality risk management”; emphasizes the importance of having predefined objectives built into the development process. An analytical method, which is an analytical procedure that includes all steps in the procedure, constitutes an important step in the QBD lifecycle approach. Together, Quality by Design (QBD) and analytical methods become an important component of the three-stage process of method validation, which are:

  • Stage one, which relates to method design
  • Stage two, which relates to method qualification, and
  • Stage three, which is about continued method verification

 Reference:

http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=791903

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