CS Analytical Laboratory, the world’s only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services specifically for drug product and medical device container systems is excited to announce that it will be launching an educational webinar initiative, with regularly scheduled presentations and Q&A discussions centered on key topics and trends in container and package system regulatory qualification. The first webinar is scheduled for Wednesday, December 7, 2022 at 10:00am through 11:30am EST and will cover “Comprehensive Container & Package System Qualification for Deep and Ultra-Cold Storage Products”. This initial webinar will be hosted by Brandon Zurawlow, Chief Scientific Officer for CS Analytical. These webinars are free of charge and attendees may register here.

“Over the past decade, the requirements for regulatory qualification of container and package systems have undergone numerous changes. CS Analytical has remained at the forefront of these developments,” commented CS Analytical CEO Brian Mulhall, “As part of our ongoing commitment to industry engagement and education, the webinars are designed to share our experience and insight with clients and foster industry discussion on changing regulatory expectations and best practices.”

In today’s marketplace, unique products such as cell and gene therapies, mRNA, and some viral vector vaccines are examples where storage temperatures below those of traditional drug products are often required. Package systems that will be holding, shipping and/or storing products at deep and ultra-cold temperatures (below -60° C) can introduce risk and challenges to the integrity of the primary package system due to changes to elastomer viscoelasticity and overall component shrinkage potential. This first webinar will present a clear review of relevant risks, regulatory considerations, and a defined roadmap for generating packaging data for cold storage systems in accordance with USP 1207 Container Closure Integrity and other industry best practices throughout all phases of the product lifecycle, from development to distribution. Key topics to be covered include:

  • Package Development
  • Compendial USP Tests
  • Non-compendial Tests
  • Dimensional Analysis
  • Capping Line Qualification
  • Residual Seal Force
  • USP 1207 Headspace
  • Method Validation
  • Transport Validation
  • Clinical Batch CCI
  • CCI on Stability
  • Control Strategies

Webinar attendees will gain valuable insight into how best to introduce a flexible and scalable program that will comprehensively characterize and address critical concerns for product manufacturers while mitigating risk to the product, business and most importantly, the patient.