Vials, stoppers & seals compatibility studies

By Jen Roark

March 03, 2022

The FDA has approved over twenty (20) cell and gene therapy drugs, and with the rapid growth of the cell and gene therapy market, there is greater demand than ever to demonstrate container-closure integrity (CCI) at ultra-low temperatures. To preserve the product’s efficacy, most cell and gene therapy drugs are stored at temperatures below -60ºC. Many of these products are packaged in either vial systems or cryogenic freezing bags. While each of these container-closure systems poses a unique challenge for the evaluation of CCI at ultra-low temperatures, the discussion in this blog focuses specifically on vial systems.

Vials Stoppers and Seals

By Dr. Heike Kofler

July 15, 2021

Liquid injectable drugs can be contained in a pre-filled syringe system, a cartridge-based system, or a vial-based system (with a rubber stopper and seal). For a vial-based system, the drugs first are aseptically filled into glass or polymer vials. During the subsequent Fill & Finish operations, the vials are closed temporarily by inserting a rubber stopper into the vial orifice. This is prior to crimping with an aluminum seal, which results in the final integral vial-based container closure system.

SmartDose and IN Syringe

By Fran DeGrazio

July 08, 2021

One of the increasing trends in the world of drug-device combination products is the use of platforms for drug families, delivery device technologies, and primary packaging.

Cancer Patient getting treatment

By Victoria Morgan

February 04, 2021

Cancer affects all of us, whether we are a patient, a family member, a friend, or a colleague of someone fighting cancer. Working together, we can increase our understanding of this disease and support the groundbreaking research that is ongoing in the fight against cancer.

Daikyo D Sigma Pistons

By Christa Jansen-Otten

July 20, 2020

Innovation in manufacturing involves a spectrum of evolution improvements resulting in what West’s partner Daikyo Seiko, Ltd. considers "Absolute Quality." Recent continuous improvement efforts helped Daikyo achieve even higher levels in cleanliness of elastomer products.

By Your Side for Expertise

By Rohit Vora

July 01, 2020

Fill-Finish engineering and process development are a critical step to ensuring product quality and manufacturability for injectable products. Fill-Finish involves technique driven process steps with considerations around patient safety at the forefront of each step. The complexity of aseptic processing and sterile fill-finish operations will continue to grow as more complex drug products enter the pipeline.