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Many parenteral drug products, such as monoclonal antibodies, are susceptible to degradation over time. To enable a longer shelf life, such drugs are often stored in a lyophilized state. Lyophilization (freeze-drying) is a process by which water is removed from a drug product. In the absence of water, all metabolic processes stop, making lyophilized drug products far more stable.
In considering the container closure integrity (CCI) performance of a vial/stopper/seal system for a lyophilized drug product, a key element is resistance to exposure to water. It is often wrongly assumed that exposure to water occurs only as a result of residual water in the elastomer stopper. However, there are several possibilities, including:
To help reduce these possibilities, it is very important to consider the material properties of the vial, stopper and seal, and their treatment prior to use. For example, stoppers are often sterilized by autoclaving (steam at approximately 120°C), so it is necessary to ensure stoppers are properly dried before use to minimize risk of releasing residual water.
West offers vials, stoppers and seals well-suited for lyophilized drug products, including:
For more on how West supports lyophilized drug products, visit our website or contact a Technical Customer Service (TCS) representative in your region.
PLASCAP® and Daikyo Crystal Zenith® are registered trademarks of Daikyo Seiko, Ltd.
LyoSeal® is a registered trademark of West Pharmaceutical Services Deutschland, GmBH, a subsidiary of West Pharmaceutical Services, Inc.
Lyophilization (freeze drying) is the process of dehydrating a drug product at low temperature and reduced pressure. Absent water, degradation processes are greatly reduced; thus, it helps to enhance drug product stability. Moisture-sensitive drug products are often marketed in lyophilized form. For a primary package system, the selection of appropriate components is essential to prevent risks associated with alteration of the lyophilized drug product prior to reconstitution and use.
Many injectable drug products, such as monoclonal antibodies and recombinant proteins, are susceptible to degradation over time when stored at ambient temperature. As such, they are stored, and subsequently delivered, in a lyophilized state - which enables a much longer shelf life. Lyophilization (also known as <em>freeze-drying</em>) is a process by which all water is removed from a drug product. Absent water, all metabolic processes stop, and drug products thus stored in a lyophilized condition are far more stable. At the time of use, the lyophilized drug product is reconstituted with water (or other appropriate solution) and delivered to the patient.
<p>The LyoSeal® cap— an all-plastic, instant sealing solution for lyophilized drugs—recently launched at Pharmapack 2017. Plastic seals present a unique opportunity for commercial pharmaceutical manufacturing, as well as for R&D and pre-clinical applications seeking simplified manual capping options (no tools required).</p>
Lyophilization (also called freeze drying) is the process of dehydrating a material at low temperature and reduced pressure. It is used to extend the shelf life of many biologic drug products. Absent water, drug metabolic degradation processes are greatly reduced. Clearly, it is crucial to know the water content of elastomer stoppers for vial-based primary packaging systems for lyophilized drug products.
Lyophilization is widely used for pharmaceuticals to help preserve parenteral drugs that are unstable in liquid formulation, particularly biologics. Lyophilized drugs have many advantages like prolonged shelf life, easy dissolution and good stability. However, a suitable container closure system is necessary to ensure the successful lyophilization of pharmaceutical products while maintaining product quality.
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