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Pharmaceutical

The pharmaceutical industry demands the highest grade of sealing solutions that must also conform to strict legislative requirements. All seals within the medical industry – including bottling seals and dosing seals – must demonstrate extraordinary resistance against a wide range of active pharmaceutical ingredients (APIs), process media, and cleaning materials, making seal choice a critical element for all industrial applications. Outstanding chemical resistance, mechanical performance and low contamination levels are just some of the capabilities that the best pharmaceutical seals can offer.

Sealing Solutions for all Pharmaceutical Applications

Wherever fluid, solids, or gases are contained or transferred, the role of a reliable seal is determined by its chemical resistance and ability to prevent contamination consistently. These necessities are true for both off-the-shelf and bespoke seal designs. At Chesterton Customseal, our medical-grade seals conform to the highest regulations and can be manufactured in various materials to suit any medical application. Highly effective sealing solutions must address all the performance factors to guarantee compliance and longevity.

Our pharmaceutical sealing experts can advise and create robustly, outstanding quality seals that best suit your requirements. We use the highest grades of elastomer and plastic materials to ensure the highest performance levels. This, combined with patented-seal designs and a design process to develop even the most complex custom components when needed, elevates Chesterton Customseal pharmaceutical and medical seals – including bottling and dosing seals – to the highest possible level.

Get in contact to discuss your pharmaceutical sealing needs today.

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.

  1. Hygienic & sterile: Seals must be constructed so that they can be easily and reliably cleaned to ensure a sterile manufacturing process.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.

 

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