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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.

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 minimized.

 

A leaking seal can lead to catastrophic failure, contamination, and system breakdown in high pressure and ultra-high pressure liquid chromatography systems. Chesterton Customseal provides high-performance Spring Energised Seals that are custom-engineered and precision manufactured to fit around the positive displacement (PD) piston pump and prevent seepage of eluent used in these high-pressure pumps. They offer effective sealing in a wide range of temperatures, pressures and media types, strong resistance to abrasion and increased service life in mobile phases, especially when buffer salts are present.

Two of the most widely used materials are UHMW-PE and graphite filled PTFE.

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 minimized.

 

A leaking seal can lead to catastrophic failure, contamination, and system breakdown in high pressure and ultra-high pressure liquid chromatography systems. Chesterton Customseal provides high-performance Spring Energised Seals that are custom-engineered and precision manufactured to fit around the positive displacement (PD) piston pump and prevent seepage of eluent used in these high-pressure pumps. They offer effective sealing in a wide range of temperatures, pressures and media types, strong resistance to abrasion and increased service life in mobile phases, especially when buffer salts are present.

Two of the most widely used materials are UHMW-PE and graphite filled PTFE.

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