Webinars
Package Validations – A Look at Current and Future State Testing
09.11.19
Wednesday, September 11th, 2019 - 1:00 PM ET
This webinar will highlight the significant changes implemented with the release of the EU’s MDR and its impact on packaging requirements. Specifically, these new regulations prompted changes within the packaging industry, resulting in the newly published ISO 11607. A discussion on three key points regarding medical device packaging will be discussed and how ISO 11607 directs manufacturers to meet these changes. Additionally, a brief examination will be offered of the lifecycle approach to packaging validations, including an in-depth look at a couple of specific tests. Finally, a high-level review of sample size considerations as part of the establishment of a validation testing plan will be provided.
SPEAKER:
Wendy Mach, Consulting Manager, Nelson Labs
Wendy Mach has over 24 years of medical device manufacturing and laboratory experience. She worked in the medical manufacturing environment in Minnesota for seven years, performing ethylene oxide (EO) and gamma radiation sterilization validations. While at the manufacturing site, she also insourced the microbiology tests for sterility assurance and related equipment validation. Wendy also spent four years as a lab supervisor, managing the sterility, microbial limits, bioburden, endotoxin, antimicrobial effectiveness services. In 2004 Wendy moved to Salt Lake City to accept a position in the EO department at Nelson Laboratories and was responsible for sterilization D-value and packaging microbial aerosol challenge studies.
She is a participating member on the Technical Committee ISO/TC 198 Sterilization of Healthcare Products, the subcommittee chairperson for ASTM F02.15 Chemical / Safety Properties, and is a member of the Packaging and Distribution Expert Committee for United States Pharmacopeia (USP). Wendy’s participation on the domestic and international committees allows her to consult with clients to meet the regulatory standards of today – while preparing them to meet the standards of the future.
This webinar will highlight the significant changes implemented with the release of the EU’s MDR and its impact on packaging requirements. Specifically, these new regulations prompted changes within the packaging industry, resulting in the newly published ISO 11607. A discussion on three key points regarding medical device packaging will be discussed and how ISO 11607 directs manufacturers to meet these changes. Additionally, a brief examination will be offered of the lifecycle approach to packaging validations, including an in-depth look at a couple of specific tests. Finally, a high-level review of sample size considerations as part of the establishment of a validation testing plan will be provided.
SPEAKER:
Wendy Mach, Consulting Manager, Nelson Labs
Wendy Mach has over 24 years of medical device manufacturing and laboratory experience. She worked in the medical manufacturing environment in Minnesota for seven years, performing ethylene oxide (EO) and gamma radiation sterilization validations. While at the manufacturing site, she also insourced the microbiology tests for sterility assurance and related equipment validation. Wendy also spent four years as a lab supervisor, managing the sterility, microbial limits, bioburden, endotoxin, antimicrobial effectiveness services. In 2004 Wendy moved to Salt Lake City to accept a position in the EO department at Nelson Laboratories and was responsible for sterilization D-value and packaging microbial aerosol challenge studies.
She is a participating member on the Technical Committee ISO/TC 198 Sterilization of Healthcare Products, the subcommittee chairperson for ASTM F02.15 Chemical / Safety Properties, and is a member of the Packaging and Distribution Expert Committee for United States Pharmacopeia (USP). Wendy’s participation on the domestic and international committees allows her to consult with clients to meet the regulatory standards of today – while preparing them to meet the standards of the future.
Maximizing Yield, Minimizing Waste Through Precise Dosing Techniques
07.23.19
Tuesday, July 23rd, 2019 - 2:00 PM ET / 11:00 AM PT
Flexible and reproducible dosing of small amounts of liquids for maximum yield can be achieved with the time-pressure dosing method. It is particularly suited to laboratory and diagnostic applications that must ensure the tiniest volumes of liquid flow quickly, precisely and with repetitive accuracy in your filling machines. This webinar highlights the differences between commonly used industry solutions and the time-pressure dosing method. Learn how the system works, challenges to be aware of and advantages achieved such as: higher yield, minimized installation space, increased process reliability, greater availability, and reduced number of interfaces.
SPEAKERS:
Craig Occhiato
Segment Manager, Microfluidics Division at Bürkert Fluid Control Systems
Craig is the resident Industry Expert for the IVD, Genomics, Life & Bio Science industry sectors in the US. With over 25 years’ experience in the field of fluid and liquid handling & control, he previously led the Bürkert USA Engineering team before his move to a global role in Microfluidics.
Christoph Hettinger
System Engineer at Bürkert Fluid Control Systems
For over 10 years, Christoph has been a system engineer in the Bürkert Systemhaus and was previously a product engineer for over 20 years with Bürkert. He is a resident expert in designing fluid handling systems mainly in micro applications like IVD, genomics, filling, analytical and medical applications where small amounts of liquids must be handled with high precision.
Flexible and reproducible dosing of small amounts of liquids for maximum yield can be achieved with the time-pressure dosing method. It is particularly suited to laboratory and diagnostic applications that must ensure the tiniest volumes of liquid flow quickly, precisely and with repetitive accuracy in your filling machines. This webinar highlights the differences between commonly used industry solutions and the time-pressure dosing method. Learn how the system works, challenges to be aware of and advantages achieved such as: higher yield, minimized installation space, increased process reliability, greater availability, and reduced number of interfaces.
SPEAKERS:
Craig Occhiato
Segment Manager, Microfluidics Division at Bürkert Fluid Control Systems
Craig is the resident Industry Expert for the IVD, Genomics, Life & Bio Science industry sectors in the US. With over 25 years’ experience in the field of fluid and liquid handling & control, he previously led the Bürkert USA Engineering team before his move to a global role in Microfluidics.
Christoph Hettinger
System Engineer at Bürkert Fluid Control Systems
For over 10 years, Christoph has been a system engineer in the Bürkert Systemhaus and was previously a product engineer for over 20 years with Bürkert. He is a resident expert in designing fluid handling systems mainly in micro applications like IVD, genomics, filling, analytical and medical applications where small amounts of liquids must be handled with high precision.
5 Methods for Excelling at Cleanroom Manufacturing
07.10.19
NOW AVAILABLE ON-DEMAND
Join Steve Bieszczat, CMO of IQMS/Dassault Systemes to learn how you can excel at cleanroom manufacturing in 2019. Steve will share the latest survey results that IQMS and MAPP have recently generated from a survey of plastics manufacturers. Also provided will be an update on the latest approaches manufacturers are taking to adding digital technologies to improve their shop floor productivity, all related to improving cleanroom manufacturing quality and performance.
SPEAKER:
Steve Bieszczat, CMO, IQMS/Dassault Systems
Steve is responsible for all aspects of IQMS' brand management, demand generation and product marketing. Prior to IQMS, Steve held senior marketing roles at ERP companies Epicor, Activant and CCI-Triad. Steve holds an engineering degree from the University of Kansas and an MBA from Rockhurst.
Join Steve Bieszczat, CMO of IQMS/Dassault Systemes to learn how you can excel at cleanroom manufacturing in 2019. Steve will share the latest survey results that IQMS and MAPP have recently generated from a survey of plastics manufacturers. Also provided will be an update on the latest approaches manufacturers are taking to adding digital technologies to improve their shop floor productivity, all related to improving cleanroom manufacturing quality and performance.
SPEAKER:
Steve Bieszczat, CMO, IQMS/Dassault Systems
Steve is responsible for all aspects of IQMS' brand management, demand generation and product marketing. Prior to IQMS, Steve held senior marketing roles at ERP companies Epicor, Activant and CCI-Triad. Steve holds an engineering degree from the University of Kansas and an MBA from Rockhurst.
Solution Development For Engineered Resins
12.04.18
NOW AVAILABLE ON-DEMAND
The development of new products always has unknown issues when it comes to performance, compatibility of materials, shelf life and aging. When one is trying specific materials, the final materials selected will be required to fit together into the entire device and function per the device requirements. One would call this "fit for use" per the final application. Not only are the form, fit and functionality important, but the material must be able to pass all regulatory hurdles around the globe.
The list of attributes one must consider will depend upon the final use that may include assembly, special packaging, sterilization, and one item many companies spend more time on - aesthetics. This webinar will help outline many of these attributes and aid in the development of a materials selection process.
The development of new products always has unknown issues when it comes to performance, compatibility of materials, shelf life and aging. When one is trying specific materials, the final materials selected will be required to fit together into the entire device and function per the device requirements. One would call this "fit for use" per the final application. Not only are the form, fit and functionality important, but the material must be able to pass all regulatory hurdles around the globe.
The list of attributes one must consider will depend upon the final use that may include assembly, special packaging, sterilization, and one item many companies spend more time on - aesthetics. This webinar will help outline many of these attributes and aid in the development of a materials selection process.
SPEAKERS:
Gaurav Kapoor
CTO - Spectrum Plastics Group
Larry Wallace
Senior Staff Scientist - Spectrum Plastics Group
CTO - Spectrum Plastics Group
Larry Wallace
Senior Staff Scientist - Spectrum Plastics Group
MODERATOR:
Sean Fenske
Editor-In-Chief - MPO / ODT
Irritation Testing Is Becoming Less Irritating
10.24.18
NOW AVAILABLE ON-DEMAND
Medical devices around the world are required to be assessed for biocompatibility to determine how the materials and manufacturing processes affect the patient based on contact type and duration. There are three basic tests in this analysis that are applicable for every medical device: cytotoxicity, sensitization, and irritation. We call these the "Big Three". While these tests provide valuable information and protect patients, they also come at a cost in animal lives. Until recently, only cytotoxicity was performed in vitro, meaning "in glass" or not using animals; while sensitization and irritation testing still require the use of animals. Earlier in 2018 a series of articles was published in Toxicology In Vitro reporting data from an international Round Robin study to determine the reliability and predictivity of an in vitro irritation method for assessing medical devices. This data is driving change in irritation testing impacting international testing standards (ISO 10993-10) and seeking regulatory acceptance in the US. In this webinar, we will discuss the history of irritation testing, the innovations that have lead to this change, the incorporation of the method into international acceptance, and where the method is in all of this process.
Medical devices around the world are required to be assessed for biocompatibility to determine how the materials and manufacturing processes affect the patient based on contact type and duration. There are three basic tests in this analysis that are applicable for every medical device: cytotoxicity, sensitization, and irritation. We call these the "Big Three". While these tests provide valuable information and protect patients, they also come at a cost in animal lives. Until recently, only cytotoxicity was performed in vitro, meaning "in glass" or not using animals; while sensitization and irritation testing still require the use of animals. Earlier in 2018 a series of articles was published in Toxicology In Vitro reporting data from an international Round Robin study to determine the reliability and predictivity of an in vitro irritation method for assessing medical devices. This data is driving change in irritation testing impacting international testing standards (ISO 10993-10) and seeking regulatory acceptance in the US. In this webinar, we will discuss the history of irritation testing, the innovations that have lead to this change, the incorporation of the method into international acceptance, and where the method is in all of this process.
SPEAKER:
Audrey Turley
Senior Biocompatibility Expert - Nelson Labs
MODERATOR:
Sean Fenske
Editor-In-Chief - MPO / ODT
