The Webinar Series aims to support INTERPHEX's robust conference program and will serve as the industry's year round education resource, covering the hottest topics and trends.
Taking Life Sciences to the Cloud
Date: June 12, 2014
Time: 2:00pm-3:00pm (-5 GMT)
Speakers: John Niziolek, Practice Leader, Compliance, Cornerstone OnDemand and Aaron Weinstein, Senior Director - Validation Services, IPS - Integrated Project Services
Listen to recordings of past webinars from INTERPHEX's 2012-2013 Webinar Series. The Webinar Series aims to support INTERPHEX's robust conference program and will serve as the industry's year round education resource, covering the hottest topics and trends.
Going Beyond The Batch: Benefitting From Continuous Thermal Viral Inactivation & Sterilization
Date: February 13, 2014
Time: 3:00pm-4:00pm (-5 GMT)
When used for viral inactivation, sterilization, or pasteurization of liquid biologicals such as media, pharmaceuticals, and nutraceuticals, Continuous Flow Thermal (CFT) Processing offers many crucial advantages over traditional processing. These can include:
- Lower Up-Fit Costs
- Reduced Production Times and Cost
- Higher And More Consistent Product Quality
- The Ability To Develop New Products
Optimizing a Continuous Wet Granulation Process by Understanding Granule Properties
Date: Wednesday, March 5, 2014
Time: 2:00 PM - 3:00 PM EST
In developing a continuous wet granulation process, it is easy to produce a large number of samples by varying both the formulation as well as the process parameters. Commonly used granule measurements include loss-on drying of residual moisture content, and particle size measurements from which correlations including the Carr Index and Hausner ration may be calculated. However, it is seen that these measurements are not sufficient to differentiate between a large number of samples produced at conditions which are not drastically different. Using a powder rheometer, we have been able to repeatably measure and produce reliable trends at multiple points in the process train (powder feeders, wet granules, dry granules) to determine which powder properties are critical-to-quality in generating the desired tablet properties. In this study two formulations were studied to demonstrate how to use improved understanding of granule properties to develop the design space of a continuous manufacturing process.
Emerging Market Capital Sourcing
Date: October 1, 2013
Time: 2:00pm-3:00pm (-5 GMT)
Speaker: Kevin Batche, Sr. Procurement Manager, IPS – Integrated Project Services
Evaluated from an operations standpoint rather than a technical standpoint, this webinar looks at common fears as they relate to sourcing process and packaging equipment from emerging markets. Of primary concern are the risks associated with material segregation, cross-contamination, test reports, qualification documentation, as well as parts and service after start-up.
- Benefits/Risks of emerging market capital sourcing as it relates to the execution of NA capital projects
- Learn how NA pharma owner initiatives and concerns have shaped the supplier qualification process
- Learn how the qualification process should be executed, results evaluated and the risk factor determined
The Challenges and Opportunities in Converting an Existing Facility to a Hybrid or a Single Use Facility
Date: June 6, 2013
Time: 2:00pm-3:00pm EST (-5 GMT)
Speaker: Roman Rodriguez, Mobius Group Global Manager, EMD Millipore
Converting all or part of an existing facility to single use technologies can be dictated by a diverse yet intertwined set of parameters that are technical, strategic and administrative. Additional parameters will impact the decision including personnel, schedule, current facility design, existing equipment, product comparability, and inventory control management.
This presentation will assist with the decision making process by highlighting the key considerations for each of these parameters.
By participating in this webinar, you will:
- Learn about the evolution of the Biotech market
- Understand Single-use technologies
- Review the opportunities and challenges around an Hybrid or Single-Use solution
FAST DoE by Means of Continuous Technologies
Date: Thursday, May 23, 2013
Andrew Birkmire, Process Development Manager, GEA Process Engineering Inc.
Kris Schoeters, Product Manager Continuous Processing, GEA Pharma Systems
RichardSteiner, Business Development Manager Continuous Processing, GEA Pharma Systems
Design of Experiments describes a set of controlled investigations that have been designed to evaluate process variations. Even a simple DoE is comprised of several trials, which can be time-consuming when working with the traditional batch systems.
This presentation describes a number of case studies which clearly show that using continuous technologies, the time of executing a DoE is significantly decreased.
The equipment used for the case studies is a ConsiGma™-1, the R&D version of the continuous wet granulation and drying system by GEA Pharma Systems.
The case studies described cover amongst others the influence of API properties on final product characteristics, tuning of release profiles by changing the ratio of the ingredients of a formulation, high drug load applications and melt granulation processes.
By means of these case studies, also other benefits of continuous technologies and the use of DoE will be highlighted, such as the possibility to establish a sound, scientifically-based Pat strategy that only measures those parameters that have an impact on the critical quality attributes.
- DOE to increase process knowledge and set up PAT strategy
- Continuous technologies decrease Time to market & Cost
- Continuous technologies & DOE provide increased end quality