CS Analytical Laboratory, the world’s only cGMP, FDA-regulated contract laboratory exclusively designed and dedicated to container and package testing and regulatory solutions for the pharmaceutical, biotechnology, and medical device industries, is pleased to introduce a new comprehensive service offering designed specifically for the qualification of product-package systems requiring cold storage at or below -60°C. This program, based on a holistic science-based approach according to industry best practices, is scalable to cover all stages of the product lifecycle. Services built into these comprehensive programs include:

USP / EP Qualification Testing Dimensional Analysis

  • Package Development
  • Stack-up Tolerance Analysis
  • Incoming Lot Inspection

USP 1207 Headspace Analysis

  • Method Development
  • Method Validation
  • Inherent Integrity Evaluation
  • Routine Analysis

Capping Optimization

  • Onsite Capping
  • Residual Seal Force Analysis
  • CCI Testing

Capping Line Qualification Transport Validation

  • ASTM and ISTA Distribution
  • CCI Pre- and Post-Test

Clinical Batch CCI

Stability Program CCI

“We are very excited to offer this type of program within our FDA regulated, cGMP facility,” noted Brandon Zurawlow, Chief Scientific Officer. “Having the ability to design and implement a comprehensive qualification program for cold storage package systems that spans the full product lifecycle, from development to commercialization, is a prime example of what we strive to deliver at CS Analytical. By seamlessly integrating services at key product-package and process development, validation, and routine testing phases, we can deliver a data package to our clients that is in line with current regulatory trends and best practices, and meets or exceeds all regulatory expectations.”

Cold storage products, such as cell or gene therapies, often require storage at temperatures below -20°C, and are involved in storage and distribution environments incorporating dry ice (~-80°C), or even liquid nitrogen (~-200°C). In many cases, the package systems in which these products are placed are rather traditional in nature, such as a threaded closure or crimp-top vial. However, many of the materials used in these package systems and responsible for maintaining package integrity are not typically intended for or assessed for leakage at these temperatures. When exposed to deep-cold or ultra-cold temperatures, physical changes to elastomeric components in particular can occur as materials reach or exceed their glass transition state, creating leaks at low temperatures that would otherwise not be observed while at room temperature. This type of leakage is typically observed at primary seal areas, such as that between an elastomeric closure and glass vial being used below -60°C.

The team at CS Analytical has leveraged its years of experience designing and implementing comprehensive qualification programs in addressing the market need of these new class of drugs requiring cold storage. The program can be performed as one comprehensive project that progresses with the product lifecycle starting in development, or specific test sections may be performed a-la-carte as the appropriate technology and general study approach is considered on a product-to-product basis, taking into account the regulatory need, intended storage and shipment conditions, product sensitivities, and lifecycle stage the analysis is being performed.