Seals for Life Sciences & Medical applications
+44 (0)1234832200
enquiries@ceetak.com

Life Sciences & Medical

When designing and supplying seals into critical devices and equipment we have to meet the strictest demands in product integrity. Our engineers design seals manufactured in cleanroom environments to meet detailed customer specifications.

Interactive Tools
O-Ring Calculator Chemical Compatibility Engineering Calculators
Approved Manufacturing
ISO9001:2015, ISO 14001:2015 approved and manufacturing IATF16949:2016 and ISO13485:2016 approved
Product Range
Seals manufactured, inspected, cleaned and packaged in Class 7/8 (10,000/100,000). Class 5 if required.
Engineering & Design
Support with seal design and proof of concept, mating hardware designs, material selection and development..
Quality Assurance
Seals manufactured in low leachable, UHP materials to USP Class VI, ISO 10993-1 compliance and UHP, BAM and BfR standards.

Seals for Life Sciences & Medical applications

Good Manufacturing Practices (GMP) ensures Repeatability & Reliability

Our ISO13485:2016 clean room manufacturing facilities are Class 7/8 (10,000/100,000) manufacturing. We can offer Class 5 (100) inspection, cleaning, & packaging for specific applications.

Biopharma: closed loop cleanroom manufacture for all processes including mixing/milling, moulding, post cure, de-flash, inspection, packaging.

DOE documentation: variables in the manufacturing process are tested and checked, documented and controlled. For example, material pellet size, press times and temperatures, min and max tolerances.  Statistical analysis controls and reduces the risk of inconsistencies in our products.

Our materials can be controlled through CMR (Carcinogenic, Mutagenic and Reprotoxic) regulations.

We can support with IQ,OQ,PQ studies: Installation Qualification, Operational Qualification, Performance Qualification

Materials

Constant innovation in materials development to ensure compliance with Medical Devices Regulation (MDR). UHP materials; low leachable, low extractable and fully compliant with USP Class VI, ISO 10993-1, UHP, BAM and BfR standards.

We can review and recommend material grades for each individual application, and assist with the development and testing of new compounds that meet your application needs. We can develop our base elastomer materials to meet particular requirements for bio resistance, toxicity or sterilisation capabilities.

O-Rings

Manufactured to international standards; AS568, ISO 3601, DIN 3771 and JIS, with metric and non-standard sizes also available. Produced in Nitrile (NBR), Perfluoroelastomers (FFKM) Fluorocarbon (FKM), Fluorosilicone (FVMQ), Hydrogenated Nitrile (HNBR), LSR & HCR Silicone (VMQ), Ethylene Propylene Diene Monomer (EPDM), Polyurethane (PU) elastomers. Our precision O-rings can be manufactured in materials that meet FDA, BAM, BfR, UHP, ISO10993-1 and USP Class VI approvals. We can supply O-rings with surface treatments in the form of dry or wet coatings for reducing friction, ease of installation or for colour identification.

Bespoke Gaskets

We specialise in the design and manufacture of precision rubber gaskets and seals, including push-in-place gaskets to address difficult assembly conditions. Designed specifically for each application, our highly experienced engineers optimise the seal profile geometry using calculations on groove fill, compression and installed squeeze or stretch, combined with non-linear FEA technology to simulate the performance before finalising the design. We also provide rapid prototyping and 3D printing to meet our customer test requirements before cutting production tools. Available in all elastomer compounds, including LSR and HCR silicone, and grades that are approved to international standards such as USP Class VI, FDA, NSF and ISO10993, We offer manufacturing, cleaning and packaging in ISO standard cleanrooms.

PTFE Seals & Engineered Plastics

Our PTFE cap seals, available for rod, piston, and rotary applications, are designed and manufactured in a variety of virgin or filled PTFE and elastomer material combinations depending on each application requirement. Standard seal sizes are for installation in grooves to ISO7425-2 and we can manufacture bespoke sizes and profiles; ranging from 3mm in diameter. PTFE seals with helical, cantilever or canted coil spring energisers can be tailored to any existing customer groove geometry and in numerous jacket material and spring material combinations. Alongside PTFE seals, we offer a range of PEEK and UHMWPE seal profiles, and can offer grades that meet FDA and other industry specific approvals.

Precision Mouldings

We design and manufacture precision mouldings in all elastomer materials and can either offer a full design service or advise on tolerances, hardware interference and material choice for applications where design activity is already underway. We can validate designs with non-linear FEA and can provide rapid prototyping and 3D printing before cutting production tools. Available in all elastomer compounds, including LSR and HCR silicone, and grades that are approved to international standards such as USP Class VI, FDA, NSF and ISO10993, We offer manufacturing, cleaning and packaging in ISO standard cleanrooms.

2-Shot Mouldings

We are experienced in the design and manufacture of high volume two-shot moulded parts. Using a variety of ThermoPlastic Elastomers (TPEs) and plastics such as Polypropylene (PP) or Polyamide (PA), the end result of the 2-shot moulding production process is a high integrity seal product with a powerful molecular bond between the materials. Providing key system design benefits 2-shot moulding reduces part count and simplifies assembly. Production cycle times are reduced as produced in a single manufacturing tool.

Overview

Seals for Life Sciences & Medical applications

Good Manufacturing Practices (GMP) ensures Repeatability & Reliability

Our ISO13485:2016 clean room manufacturing facilities are Class 7/8 (10,000/100,000) manufacturing. We can offer Class 5 (100) inspection, cleaning, & packaging for specific applications.

Biopharma: closed loop cleanroom manufacture for all processes including mixing/milling, moulding, post cure, de-flash, inspection, packaging.

DOE documentation: variables in the manufacturing process are tested and checked, documented and controlled. For example, material pellet size, press times and temperatures, min and max tolerances.  Statistical analysis controls and reduces the risk of inconsistencies in our products.

Our materials can be controlled through CMR (Carcinogenic, Mutagenic and Reprotoxic) regulations.

We can support with IQ,OQ,PQ studies: Installation Qualification, Operational Qualification, Performance Qualification

Materials

Constant innovation in materials development to ensure compliance with Medical Devices Regulation (MDR). UHP materials; low leachable, low extractable and fully compliant with USP Class VI, ISO 10993-1, UHP, BAM and BfR standards.

We can review and recommend material grades for each individual application, and assist with the development and testing of new compounds that meet your application needs. We can develop our base elastomer materials to meet particular requirements for bio resistance, toxicity or sterilisation capabilities.

Products

O-Rings

Manufactured to international standards; AS568, ISO 3601, DIN 3771 and JIS, with metric and non-standard sizes also available. Produced in Nitrile (NBR), Perfluoroelastomers (FFKM) Fluorocarbon (FKM), Fluorosilicone (FVMQ), Hydrogenated Nitrile (HNBR), LSR & HCR Silicone (VMQ), Ethylene Propylene Diene Monomer (EPDM), Polyurethane (PU) elastomers. Our precision O-rings can be manufactured in materials that meet FDA, BAM, BfR, UHP, ISO10993-1 and USP Class VI approvals. We can supply O-rings with surface treatments in the form of dry or wet coatings for reducing friction, ease of installation or for colour identification.

Bespoke Gaskets

We specialise in the design and manufacture of precision rubber gaskets and seals, including push-in-place gaskets to address difficult assembly conditions. Designed specifically for each application, our highly experienced engineers optimise the seal profile geometry using calculations on groove fill, compression and installed squeeze or stretch, combined with non-linear FEA technology to simulate the performance before finalising the design. We also provide rapid prototyping and 3D printing to meet our customer test requirements before cutting production tools. Available in all elastomer compounds, including LSR and HCR silicone, and grades that are approved to international standards such as USP Class VI, FDA, NSF and ISO10993, We offer manufacturing, cleaning and packaging in ISO standard cleanrooms.

PTFE Seals & Engineered Plastics

Our PTFE cap seals, available for rod, piston, and rotary applications, are designed and manufactured in a variety of virgin or filled PTFE and elastomer material combinations depending on each application requirement. Standard seal sizes are for installation in grooves to ISO7425-2 and we can manufacture bespoke sizes and profiles; ranging from 3mm in diameter. PTFE seals with helical, cantilever or canted coil spring energisers can be tailored to any existing customer groove geometry and in numerous jacket material and spring material combinations. Alongside PTFE seals, we offer a range of PEEK and UHMWPE seal profiles, and can offer grades that meet FDA and other industry specific approvals.

Precision Mouldings

We design and manufacture precision mouldings in all elastomer materials and can either offer a full design service or advise on tolerances, hardware interference and material choice for applications where design activity is already underway. We can validate designs with non-linear FEA and can provide rapid prototyping and 3D printing before cutting production tools. Available in all elastomer compounds, including LSR and HCR silicone, and grades that are approved to international standards such as USP Class VI, FDA, NSF and ISO10993, We offer manufacturing, cleaning and packaging in ISO standard cleanrooms.

2-Shot Mouldings

We are experienced in the design and manufacture of high volume two-shot moulded parts. Using a variety of ThermoPlastic Elastomers (TPEs) and plastics such as Polypropylene (PP) or Polyamide (PA), the end result of the 2-shot moulding production process is a high integrity seal product with a powerful molecular bond between the materials. Providing key system design benefits 2-shot moulding reduces part count and simplifies assembly. Production cycle times are reduced as produced in a single manufacturing tool.

Materials

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Seals for Life Sciences & Medical applications require Good Manufacturing Practices (GMP) and Repeatability & Reliability.

Our medical seals are manufactured in Class 7/8 (10,000/100,000) ISO13485:2016 clean rooms. However, we also offer Class 5 (100) inspection, cleaning, & packaging for specific applications.

View our Life Sciences & Medical seals brochure here.