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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.
A level of water that is too high could lead to a reduced shelf life, which could affect patient safety. This raises the question of how to measure water level. There are two established methods: loss on drying (LOD) and Karl Fisher titration (KF). In the pharmaceutical industry, they are often seen as equivalent; but they are not.
LOD is a gravimetric method. Weight loss after heating is judged as loss of water. But LOD cannot distinguish weight loss due to water, versus weight loss due to other compounds such as volatile organics (e.g., oligomers, antioxidants, compounds formed resultant from heating). KF, on the other hand, is a chemical method. It is specific to water, and therefore more accurate. KF is based on a redox reaction that involves stoichiometrically equivalent amounts of iodine and water – end point is measured through volumetric or coulometric means. At West, KF is used for the residual water content information provided for Westar® RU lyophilization stoppers.
Many properties of packaging components/systems and delivery devices can be measured by multiple methods. The key is to select the right methods. In this regard, West’s Analytical Lab Services is well equipped, having the staff, expertise, and facility to not only design studies that support customer needs, but to execute them the right way. For more on how West can help, contact an Account Manager or Technical Customer Support (TCS) representative.
Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
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 (<em>freeze-drying</em>) 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.
To ensure drug product efficacy, components of primary packaging and delivery systems must be evaluated for safety and performance. An essential aspect of this is an extractables and leachables (E&L) study. The purpose of an E&L study is to identify compounds (organic and inorganic) that may migrate from components into drug product formulations, in particular those that may put patient safety at risk.
Sterilization processes are fundamental and critical in the manufacturing of sterile pharmaceutical products. According to the US Code of Federal Regulations, “Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use."<sup>1</sup> When considering elastomeric components, common methods for sterilizing include steam and gamma. This is where the sterilized components with Westar™ Ready to use (RU) and Westar™ Select RU quality levels come in. Westar™ RU and Westar™ Select RU quality level products are supplied ready to be used and help simplify and speed up the drug manufacturing process while maintaining high standards of quality and safety.
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.
Rubber components are essential for the safe containment and delivery of parenteral drug products. Many rubber formulations used in the pharmaceutical industry are based on halobutyl rubbers. Halobutyl rubbers, typically bromobutyl or chlorobutyl, are made by the halogenation of butyl rubber, which is a copolymer of isobutylene and isoprene (to a smaller extent). Key features of halobutyl rubbers that make them suitable for the pharmaceutical industry are that they typically have lower levels of extractables compared to other rubbers, and they have excellent resistance to permeation by water and oxygen.
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