Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation

This article reports on an evaluation of a container closure system for the storage and transportation of frozen drug projects, such as live viral vaccines. When these items are stored in glass vials with stoppers, the elastomer of the stopper needs to be flexible enough to seal the vial at the target's lowest temperature to ensure container closure integrity and thus both sterility and safety of the drug product. The authors evaluated the impact of processing and shipment on container closure integrity (CCI) in the frozen state. They applied the ThermCCI method to evaluate the impact of shipping stress and variable capping force on CCI of frozen vials as well as to evaluate the temperature limits of rubber stoppers. They found that enabling CCI during cold storage is primarily a function of the combination of vial and stopper. Temperatures below 40 degrees C were found to pose a rise to the container integrity. They also discuss the effects of variable capping forces used to seal the containers. In addition, following the standard ASTM 7386/TS-4, shipping stress should not create a permanent impact on or damage to the container closure system.

• Record URL:
  • https://doi.org/10.5731/pdajpst.2017.008383
• Availability:
  • Find a library where document is available. Order URL: http://worldcat.org/issn/10797440
• Authors:
  • Nieto, Alejandra
  • Roehl, Holger
  • Adler, Michael
  • Mohl, Silke
• Publication Date: 2018-11

Language

• English

Media Info

• Media Type: Print
• Features: Photos; References; Tables;
• Pagination: pp 544-552
• Serial:
  • PDA journal of Pharmaceutical Science and Technology
  • Volume: 72
  • Issue Number: 6
  • Publisher: Parenteral Drug Association (PDA)
  • ISSN: 1079-7440
  • EISSN: 1948-2124
  • Serial URL: http://journal.pda.org/

Subject/Index Terms

• TRT Terms: Container handling; Containers; Drugs; Freight transportation; Frozen cargo; Logistics; Medical equipment
• Subject Areas: Freight Transportation; Materials;

Filing Info

• Accession Number: 01723040
• Record Type: Publication
• Files: TRIS
• Created Date: Nov 20 2019 9:42AM