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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All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

 

Most pharmaceutical biofilms, especially those in water systems, suffer from one major flaw: misconceptions. Strict and rigid rules for design and operations, especially when they are built on ignorance, come in the way of proper implementation of effective water systems. When myths and hype surround these systems, it is but natural that they are doomed to failure.

Those in charge of pharmaceutical biofilms, more so those who deal with water systems need to be aware of all the aspects of water systems if they have to avoid failures. Lack of it can result in costly system downtime or even product recalls. It can result in costly system downtime or even product recalls.

All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems3

Pharmaceutical biofilms, especially those in water systems, thrive on fear and hype. No long term biofilm control can be achieved using a one-size-fits-all set of rules for design and operation. Biofilm can be controlled only when it is fully grasped. This is all the more important because each water system is unique. Water systems professionals need to get to the root of how biofilm grows into their system, which, obviously, would be quite different from any other system.

This is why those in water systems need to have proper insights into what actually lies behind some common water system designs. They need to clear the air about several misconceptions on the topic.

Solid understanding of water systems

It is to clear these myths and misconceptions that the world-acclaimed guru of water systems, Dr. Teri Soli, will be presiding over a seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant, has served consumer products and FDA-regulated industries with training and troubleshooting expertise. He has authored the complete rewrite of USP Chapter 1231, which many consider to be USP’s “pharmaceutical water bible”.

Want to understand the ways of implementing a water system that fulfils the conditions set out by the regulatory agencies? Just log on to All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems to enroll for this highly practical and useful seminar. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Learning on all aspects of water systems

In this microbiology-focused education about all aspects of water systems, Dr. Soli will offer knowledge of the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system.

This interesting and interactive session will give participants insights into what actually lies behind some common water system designs and will bust a few myths about the same. The learning imparted at this course will is translatable to any system, with the result that uneventful microbial control can be achieved. This is the foundation to effective operation and design. Without this understanding, participants will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far outweigh the educational costs that could have prevented it.

Knowledge of water system validation and Change Control

A good way to get understanding of this topic is to be familiar with water system validation and Change Control. This knowledge is necessary to help them come up with ways of improving outcomes and reducing the frequency of excursion investigations. Dr. Soli will offer understanding on this at this seminar.

Dr. Soli has set out the following agenda for this seminar:

  • What makes water systems have microbial quality problems
  • Successful sanitization approaches for trouble-free water quality
  • Water system validation by logic instead of tradition
  • Understanding and controlling endotoxin
  • Harmonizing vs optimizing water microbial testing for system quality control
  • Microbial enumeration issues with high purity water systems
  • Water system investigation “how to’s” and example case studies
  • What USP Does and Doesn’t Say about PW, WFI, Pure Steam and Micro Issues.