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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.
The question is often raised as to when to choose a bromobutyl- versus a chlorobutyl-based component. The answer is – it depends. They are comparable in terms of permeability for oxygen and water. Primary differences will be found in their extractables profiles, as different compounds are employed for curing, stabilization, etc.
Given the very wide range of drug products (small molecule, biologic, gene, cell) and the very wide range of possible chemical interactions with extractables, the best approach to select the right component is through consultation with a Technical Customer Support (TCS) expert at West. Recommendations are based upon extensive product knowledge and the ability to offer tailored experimental studies (e.g., extractables and leachables) through the Integrated Solutions offering, while also keeping patient safety as the most important goal.
For more information, contact a TCS representative or Account Manager.
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.
The Parenteral Drug Association (PDA) has just issued Technical Report no. 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging.
<p>West is thrilled to announce that Lisa Bakazias, VP, Operations, Manufacturing Strategy, was recently named as our 2018 HBA Luminary.</p>
In recent years, an increasing variety of biologic drugs have been developed including vaccines, recombinant proteins, gene and cell therapies. In China, this increased demand will be reflected in a significant growth in the size of the bio-pharmaceutical industry. As a result, the Chinese government is increasing its investment.
Have you ever faced the need to identify a primary package for your drug product, but do not know where to start? Are you faced with tight timelines and component data constraints when evaluating stoppers, seals, and vials for container closure systems (CCS)? Do you need the right data for regulatory filing to support the choice of CCS for your drug product?
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