Bottling Seals & Dosing Seals: The Challenges
Perhaps more than in any other industry, the integrity of pharmaceutical seals must be content with some of the greatest challenges. These can be classified into six categories, with the right seal choice being of the utmost importance to withstand the rigours of pharmaceutical production.
- Hygienic & sterile: Seals must be constructed so that they can be easily and reliably cleaned to ensure a sterile manufacturing process.
- Conform to regulations: Because seals have direct contact with the process medium, they must adhere to all local and international industrial requirements, such as USP Class VI and FDA Approval.
- High pressures & temperature extremes: Hot and cold temperature resistance is vital. For example, the low temperatures generated during blood separation and vaccine production or the high pressures and heat generated during organic synthesis.
- Toxins, chemicals & aggressive media: Seals are in constant contact with aggressive chemicals, including those used during the production of APIs, in-vivo diagnostics and chemically manufactured agents. They must also have high resistance to SIP/CIP cleaning agents and powdery media that’s often found in the production of pressed tablets.
- Water resistance: Deionised water (DI) and water for injection (WFI) present a tough environment for elastomeric materials. Longevity is only guaranteed with seals specifically designed to resist such media.
- Purity & extractables: The necessity for high purity is demonstrated by regular extractable studies that manufacturers must meet. Seals must prevent any chemical compounds that might be extracted from packaging materials from migrating into the product.