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
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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The three RPS national boards have jointly called for legal guarantees that a pharmacist will always undertake a clinical assessment or check, and that there must be no legal loopholes that can bypass this requirement.
The leaked document, prepared by a working group of the Department of Health’s Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board, suggested that current legislation could be changed to allow a registered pharmacy professional, which could include a technician, to take responsibility for the sale and supply of pharmacy and prescription-only medicines.
The Royal Pharmaceutical Society (RPS) has said it believes a pharmacist should always be present in a pharmacy, apart from occasional short periods of time.
Responding to a leaked document produced for the Department of Health (DH) on the issue of whether pharmacy technicians should be allowed to supervise pharmacies, the RPS has issued an eight-point position statement on the role of registered technicians supervising the sale and supply of medicines.
Read More: http://snip.ly/3pujp#http://www.pharmaceutical-journal.com/news-and-analysis/news/rps-says-pharmacists-must-always-be-present-in-pharmacies/20203609.article
The significance of validation of pharmaceutical water systems can be gauged from the fact that among the number of substances, raw materials and starting materials used in the production, processing and formulation of pharmaceutical products; water takes a position of primacy. This is because the hydrogen bonds that water has, along with its polarity, lend it a set of special chemical properties. Because water has these attributes; many different compounds are able to blend with it in the form of dissolving, absorbing, adsorbing or suspension.
Yet, there is an irony, because this very unique quality of water –of its being able to blend easily –which makes it so important, also makes it a magnet and breeding ground for many contaminants. Water can meld different compounds, as well as contaminants. This is why effective and proper validation of pharmaceutical water systems is necessary and important.
Approaches to validation of pharmaceutical water systems
Validation of pharmaceutical water systems can be approached in three ways: prospective, concurrent and retrospective.
As the names suggest, prospective validation of pharmaceutical water systems is the validation that is carried out when an altogether new product is about to be introduced, or when there is a change in the process, which is likely to impact the attributes of water in the pharmaceutical product.
Concurrent validation of pharmaceutical water systems is the one that is carried out during the manufacturing process.
Retrospective validation of pharmaceutical water systems is one that is carried out after the product is out it the market. This is usually carried out when the company receives complaints about the product quality.