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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Activities involved in Computer Systems Validation

Computer Systems Validation (CSV) is central to the life sciences industry. Apart from being a regulatory requirement as set out by various regulatory authorities and practices such as the FDA, EMA, GCP, GLP, GMP and all the Predicate Rules; CSV is also very important to implement because not doing so will result in costly consequences.

These can range from:

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More than anything else, implementation of CSV is also important because it ensures that the data is accurate and the information, secure. Implementing Computer Systems Validation is also an important step in making sure that the organization restricts or prevents any loss of revenue from its main activities or from the CSV exercise itself. It also helps to thoroughly identify and close any gaps in the computer systems.

Getting CSV is very important

With all these uses of a CSV; it is imperative for life sciences organizations to understand how they can implement a CSV that is effective and compliant with domestic and international regulations. The CSV should ensure that the organization gets the most out of it while meeting regulatory requirements.

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