Seals for Life Sciences & Medical Applications
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enquiries@ceetak.com

Seals for Life Sciences & Medical Applications

When designing and manufacturing sealing solutions for applications within critical devices and equipment, the strictest demands in product integrity and the highest specifications of hygiene and cleanliness must be met.

The Life Sciences & Medical industry is one of the most demanding and stringently regulated. There are a variety of areas of product development and manufacture where seals for Life Sciences & Medical Applications are required.

Diagnostics

Technology changes over recent years mean there’s now many ways of supporting patients with accurate results. This means there can be safe management of health conditions; both at home and within a clinical setting. Either way, it’s vital that diagnostic devices and systems are developed with accuracy and speed of response. This is to enable targeted analysis and therapy. Typical applications include seals for in-vitro devices, analytical laboratory equipment, x-ray, and CT/MRI scanning equipment. We support your engineers with efficient design and project management of optimised sealing components for both clinical and patient self-diagnosis.

Patient management and care

For obvious reasons, repeatable and reliable control of the equipment used in patient management and care is paramount. Typical applications include seals for ventilators, anaesthesia pumps, respiratory therapy, monitoring equipment, minimally invasive surgery equipment and metered dose aerosols (such as inhalers). The typical demands on these types of seals include optimised working friction and wear life, critical feature’s function & tolerance control, and the management of gas, liquids, or solid media at accurate rates.

Biotech and pharmaceutical processing

Due to the continued development of complex and expensive drugs and research control media, the demand for high performance interactive components within the biotechnology process industry is crucial. Typical applications include seals for analytical equipment, pumps, valves & actuators, monitoring & control equipment and storage equipment & transportation vessels. We will support engineers on recommendations for Ultra High Purity (UHP) materials. This is for extreme applications combined with sensitive chemical media. Additionally to these elements, seal design recommendations for dead space and entrapment elimination within these applications.

Ultra High Purity (UHP) materials

Silicone based rubbers are a common choice of elastomer materials for seals used within medical devices. This is due to their biocompatibility features and resistance to bacterial growth. Commonly they’re platinum cured for injection moulded liquid silicone rubbers (LSR’s) and platinum and peroxide cured for compression moulded heat cured silicones (HCR’s). There’s a diverse range of silicone rubbers currently available in varying shore hardnesses. These are already USP Class VI or ISO 10993 approved, making them a go to choice if the specification allows.

Sometimes, an application requires a seal material to have better mechanical properties, more versatility with temperature range or media compatibility. In this case, then EPDM and FKM rubbers are also a good choice.

Many of our materials are fully compliant and have the required industry approvals, such as with FDA, USP Class VI, ISO 10993, UHP, BAM and BfR standards.

Cleanroom manufacturing

A controlled cleanroom environment is essential for manufacturing and packaging of products that must not have contact or contamination from external particulates. These include dust, dirt, airborne microbes, and aerosol particles.

It’s created and maintained by removing the air. It’s then circulated through a filtering system, and the clean and filtered air is distributed back into the cleanroom environment. This can be achieved at varying levels of cleanliness. It also depends on what’s specified for each individual manufacturing environment or the finished product requirements.

Different cleanliness levels are classified by the concentration of airborne particles within a measured space. We provide a complete cleanroom production process. From material blank production through to inspection and packaging using controlled materials within state-of-the-art cleanrooms.

Read more about our Life Sciences & Medical industry expertise HERE

Seals for Life Sciences & Medical Applications

When designing and manufacturing sealing solutions for applications within critical devices and equipment, the strictest demands in product integrity and the highest specifications of hygiene and cleanliness must be met.

The Life Sciences & Medical industry is one of the most demanding and stringently regulated. There are a variety of areas of product development and manufacture where seals for Life Sciences & Medical Applications are required.

Diagnostics

Technology changes over recent years mean there’s now many ways of supporting patients with accurate results. This means there can be safe management of health conditions; both at home and within a clinical setting. Either way, it’s vital that diagnostic devices and systems are developed with accuracy and speed of response. This is to enable targeted analysis and therapy. Typical applications include seals for in-vitro devices, analytical laboratory equipment, x-ray, and CT/MRI scanning equipment. We support your engineers with efficient design and project management of optimised sealing components for both clinical and patient self-diagnosis.

Patient management and care

For obvious reasons, repeatable and reliable control of the equipment used in patient management and care is paramount. Typical applications include seals for ventilators, anaesthesia pumps, respiratory therapy, monitoring equipment, minimally invasive surgery equipment and metered dose aerosols (such as inhalers). The typical demands on these types of seals include optimised working friction and wear life, critical feature’s function & tolerance control, and the management of gas, liquids, or solid media at accurate rates.

Biotech and pharmaceutical processing

Due to the continued development of complex and expensive drugs and research control media, the demand for high performance interactive components within the biotechnology process industry is crucial. Typical applications include seals for analytical equipment, pumps, valves & actuators, monitoring & control equipment and storage equipment & transportation vessels. We will support engineers on recommendations for Ultra High Purity (UHP) materials. This is for extreme applications combined with sensitive chemical media. Additionally to these elements, seal design recommendations for dead space and entrapment elimination within these applications.

Ultra High Purity (UHP) materials

Silicone based rubbers are a common choice of elastomer materials for seals used within medical devices. This is due to their biocompatibility features and resistance to bacterial growth. Commonly they’re platinum cured for injection moulded liquid silicone rubbers (LSR’s) and platinum and peroxide cured for compression moulded heat cured silicones (HCR’s). There’s a diverse range of silicone rubbers currently available in varying shore hardnesses. These are already USP Class VI or ISO 10993 approved, making them a go to choice if the specification allows.

Sometimes, an application requires a seal material to have better mechanical properties, more versatility with temperature range or media compatibility. In this case, then EPDM and FKM rubbers are also a good choice.

Many of our materials are fully compliant and have the required industry approvals, such as with FDA, USP Class VI, ISO 10993, UHP, BAM and BfR standards.

Cleanroom manufacturing

A controlled cleanroom environment is essential for manufacturing and packaging of products that must not have contact or contamination from external particulates. These include dust, dirt, airborne microbes, and aerosol particles.

It’s created and maintained by removing the air. It’s then circulated through a filtering system, and the clean and filtered air is distributed back into the cleanroom environment. This can be achieved at varying levels of cleanliness. It also depends on what’s specified for each individual manufacturing environment or the finished product requirements.

Different cleanliness levels are classified by the concentration of airborne particles within a measured space. We provide a complete cleanroom production process. From material blank production through to inspection and packaging using controlled materials within state-of-the-art cleanrooms.

Read more about our Life Sciences & Medical industry expertise HERE