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Pharmaceutical

Chesterton Customseal provides high-performance sealing solutions engineered to meet the rigorous standards and critical demands of the pharmaceutical and medical industries — delivering reliability, durability, and compliance without compromise.

Sealing Solutions for the Pharmaceutical Industry

The pharmaceutical industry requires sealing solutions of the highest standard — engineered not only for exceptional performance but also for full compliance with stringent regulatory requirements. From bottling to dosing applications, every seal must deliver proven resistance to a wide range of active pharmaceutical ingredients (APIs), diverse process media, and powerful cleaning agents, making seal selection a mission-critical decision.

Reliable Sealing for Pharmaceutical & Medical Applications

Wherever fluids, solids, or gases are transferred or contained, sealing performance is defined by two critical factors: chemical resistance and the ability to consistently prevent contamination. At Chesterton Customseal, our medical-grade seals are manufactured to the highest regulatory standards and can be tailored in a variety of materials to suit even the most demanding pharmaceutical and medical applications.

Regulatory Confidence

All seals are designed and manufactured to meet the strictest industry standards, ensuring full compliance with global pharmaceutical regulations.

Exceptional Chemical Resistance

Engineered to withstand aggressive APIs, cleaning agents, and diverse process media without degradation, ensuring long-lasting performance.

Advanced Material Selection

Utilising premium elastomers and plastics, our seals deliver superior mechanical strength, durability, and resistance to contamination.

Customised Solutions

From complex geometries to specialised applications, our patented design capabilities enable us to create tailored sealing solutions that fit your exact requirements.

Bottling Seals & Dosing Seals: The Challenges

Hygienic & Sterile

Seals must be designed for easy, reliable cleaning to maintain a sterile manufacturing environment and safeguard product integrity.

Regulatory Compliance

Because seals come into direct contact with process media, they must comply with stringent local and international standards — including USP Class VI and FDA approvals.

Extreme Pressure & Temperature Resistance

From the sub-zero conditions of blood separation and vaccine production to the high heat and pressure of organic synthesis, seals must withstand wide-ranging operational extremes without compromising performance.

Resistance to Chemicals & Aggressive Media

Seals are continuously exposed to harsh environments, from potent chemicals used in API production and in-vivo diagnostics to SIP/CIP cleaning agents and abrasive powder media in tablet manufacturing. They must deliver exceptional resistance and durability in every scenario.

Water Resistance

Deionised water (DI) and water for injection (WFI) are particularly challenging for elastomeric materials. Only seals engineered for these demanding conditions can deliver long-term reliability.

Purity & Extractables

With extractables testing now a regular regulatory requirement, seals must meet the highest purity standards. They should prevent any migration of chemical compounds from packaging materials into the final product.

Critical Components in HPLC

High-performance liquid chromatography (HPLC)

High-performance liquid chromatography (HPLC) is a chromatographic technique used to separate a mixture of compounds in analytical chemistry and biochemistry to identify, quantify, or purify the individual components of the mixture. HPLC is considered an instrumental technique of analytical chemistry (as opposed to a gravimetric technique). HPLC has many uses including medical (e.g. detecting vitamin D levels in blood serum), legal (e.g. detecting performance enhancement drugs in urine), research (e.g. separating the components of a complex biological sample, or of similar synthetic chemicals from each other), and manufacturing (e.g. during the production process of pharmaceutical and biological products).

The schematic of an HPLC instrument typically includes a sampler, pumps, and a detector. The sampler brings the sample mixture into the mobile phase stream which carries it into the column. The pumps deliver the desired flow and composition of the mobile phase through the column. The detector generates a signal proportional to the number of sample components emerging from the column, hence allowing for quantitative analysis of the sample components. A digital microprocessor and user software control the HPLC instrument and provide data analysis.

HPLC instrument diagram1) Solvent reservoirs, (2) Solvent degasser, (3) Gradient valve, (4) Mixing vessel for delivery of the mobile phase, (5) High-pressure pump, (6) Switching valve in “inject position”, (6′) Switching valve in “load position”, (7) Sample injection loop, (8) Pre-column (9) Analytical column, (10) Detector (i.e. IR, UV), (11) Data acquisition, (12) Waste or fraction collector.

The basic concept within the pump head is that the plungers are driven in and out by a motor. At the inlet & outlet ends of the pump, the head is a set of check valves. These valves only allow liquid to flow in one direction, from the mobile phase reservoir to the autosampler, column, and detector. One critical area within the set-up is the plunger seals, they play a crucial role in the overall system performance.

Four basic requirements of a plunger seal designer:

  1. Leak-free sealing – prevent any mobile phase from leaking from around the sapphire plunger
    A leak can cause fluctuations in retention time. Incorrect flow rates may cause system shut-down if enough solvent is present, and if you are using a high pressure mixing gradient system the mobile phase ratios may be incorrect.
  2. Flexibility- allow for the movement of the sapphire plunger across its surface.
  3. Chemically resistant – to a wide range of mobile phase solvents and modifiers.
  4. Strength – robust and durable enough that the frequency of replacement is minimised.

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Featured Products

Sealing Excellence for Pharmaceutical and Medical Applications

Explore our featured range of pharmaceutical sealing solutions, engineered to meet the industry’s most demanding standards. From bottling and dosing to complex process equipment, our seals provide the confidence you need to maintain purity, prevent contamination, and keep operations running smoothly.

30K Advanced Lip Seal

Innovative PTFE lip seal engineered for exceptional sealing performance and reliable contamination prevention in demanding rotary applications.

Chesterton 30KC Polymer Seal

High-performance filled PTFE cartridge designed to handle shear, heat, and abrasives, outperforming conventional packing in sealing viscous fluids and powders.

Chesterton Custom Cap Seals (CCS)

High performance, dual component system for bidirectional sealing in hydraulic and pneumatic applications

Chesterton SES 100 Series

The 100 Series features a U-shaped seal jacket combined with a high-performance stainless steel V-shaped cantilever spring and an asymmetric single-point seal profile, delivering exceptional leakage control while minimising friction.

SES 300 Series

Helical-wound spring design delivers high load capacity with minimal deflection, ideal for static applications, low-speed operation, and extreme low-temperature conditions.

SES 500 Series

Unidirectional design fits deep-stuffing-box hardware, suitable for rotary and reciprocating applications. Multi-purpose stacked sets are available in both solid and split configurations.

Explore More Industries

Explore Chesterton’s range of high-performance solutions designed to protect critical assets, extend equipment life, and improve operational efficiency.

Ensure reliability, compliance, and purity in your operations

Get in touch with our expert team today to find the perfect pharmaceutical sealing solution for your critical applications.