Engineered Sealing Solutions for the Life Sciences Industry

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1 Engineered Sealing Solutions for the Life Sciences Industry TFBMJOH TPMVUJPOT

2 Company Profile Ceetak Ltd is a leading UK designer, developer and supplier of seals and sealing solutions. Established for over 40 years, and part of the Ceetak Holdings Group, our Head Office is based in Bedford, England. Our products and systems are used throughout all major industries; from the most technically demanding applications through to high quality, high volume precision components. Ceetak s team of Sales, Project and Application Engineers are able to assist in the design of seals for Life Science applications. Our Engineers fully understand the variety of technical challenges when designing and manufacturing components for these critical conditions. Engineering Design and Quality Assurance We provide unrivalled technical and engineering support to ensure our customers benefit from the best possible seal performance at optimum cost. Ceetak is dedicated to providing a complete design service; from initial seal geometry and profile choice, to material selection and prototyping, through to final production. We work closely with your Engineers to provide the most effective sealing solutions for each bespoke application. Our Application Engineers utilise years of seal design experience and materials expertise, alongside technology such as 2D/3D CAD and FEA analysis programs to simulate performance before finalising each individual seal design. We provide both in-house and on-site technical support and have the skills, experience and resources to assist customers in all industries; regardless of the complexity or challenges involved in each application. We have a broad range of base compounds available for development specifically for the Life Sciences and Medical industry. Our experienced Materials Engineers are on-hand to develop compounds to meet the specific requirements of your individual application. To meet the required standards and approvals demanded by industry, strict quality procedures are maintained at all stages of our design service, development and manufacture process. We are ISO9001:2008 and ISO14001:2004 approved, with our manufacturing partners approved to TS16949:2009 and ISO Ceetak has a dedicated team of Quality Engineers and Quality Inspectors ensuring that advanced product quality planning is at the heart of our quality function. Fundamental activities include; mitigation of risk during all manufacturing processes, anticipating potential risks, regular review of process controls and stability, PPAP review, continuous monitoring of production SPC data, regular audits of manufacturing facilities and monthly manufacturing performance monitoring. We regularly challenge our manufacturing facilities for continuous improvements to processes including follow up-audits to ensure implementation of adequate prevention measures to avoid repeat issues, analysis and review of similar products to prevent future issues, effective root cause analysis and preventative actions review. Our stringent quality principles and proactive controls mean our customers have reduced claims and associated costs, increased change control and prevention of productivity loss and line-stops.

3 Patient Management and Diagnostics The importance of repeatable and reliable control of equipment for patient care is paramount. When specifiying and optimising components that influence this, Ceetak is able to support Design Engineers from the onset to ensure the correct sealing solution is provided. Typical demands include: Optimised working friction and wear life Critical features function and tolerance control Gas, liquid or solid media management at accurate rates Accreditation requirements e.g.,, Ease of maintenance Biotechnologies and Pharmaceutical With the continued development of complex and expensive drugs and research control media, the demand for high performance interactive components is vital. Ceetak s Application Engineers are able to support each customer with specifically developed sealing systems that meet the extreme application conditions required. We can supply sealing components that are produced in clean room condition manufacturing cells, with control on batch-to-batch consistency and in pure grade compounds ( - U.H.P.) Typical demands include: Temperature extremes - e.g C to +320 C (metal seals available beyond these temperatures) Extreme vacuums and high pressure, high rotary and reciprocating speeds (low compression, low wear rate) Special clean room manufacture and packaging with U.H.P./ grade compounds (low outgassing, low extractables) Support on material selection for aggressive media with optimised compounds (e.g. low swell rate, chemically stable) Engineering support on design of the seal with interacting parts (e.g. ease of maintenance, dead space elimination) Drug Delivery Whether the product is disposable or re-usable, Ceetak s Application Engineers can support customers with design and development of products requiring sealing devices. We ensure reliable interaction between static and dynamic mating parts via 3D modelling, rapid prototyping and Finite Element Analysis (FEA) if required. Our extensive knowledge of profile optimisation, material formulation and physical properties ensures the best fit for function sealing solutions. Typical demands include: Toxicologically safe elastomers with clear history of bio-compatibility (e.g. & USP Class VI approved materials, made from white list ingredients Seals manufactured and clean packaged in controlled process environments (e.g. Cleanroom class ,000) Elastomers that are compatible with sterilisation processes, e.g. gamma radiation, auto-claving and chemical sterilisation Compression set and stress strain relaxation stable compounds, allowing optimised storage times and life expectancy. Seals can be safely stored in devices for long periods of time Accuracy of manufacture with controlled batch-to-batch production e.g. significant feature control, dimensions, hardness and surface finish

4 Life Sciences Product Overview Miniature Elastomer Seals Ceetak is able to create high quality and consistent bio-compatible precisionelastomeric medical components using materials that comply with USP Class VI and ISO This process enables the creation of smooth surfaces and overmoulding with materials such as plastic, metal and other substances. O-Rings O-Rings are available in all AS568 inch sizes and a wide range of metric sizes (DIN 3771, ISO 3601 and JIS B2401) as well as custom sizes. Ceetak O-Rings can be moulded in a wide range of elastomer compounds, from basic neoprene to perfluorinated materials such as ParafluorTM. Custom Moulded or Machined Shapes Custom moulded or machined seals are available in virtually any range of shapes and cross sections. Ceetak designs and manufactures engineered elastomeric shapes, both homogenous and inserted, for sealing systems and isolation applications. ParFabTM Extruded Profiles Ceetak offers a wide variety of standard extruded profiles in many configurations such as solid and hollow-o, solid and hollow-d, U-channel, rectangular, solid and hollow square and hollow-dart. These products can be shipped on spools in long continuous lengths. 2-Shot Mouldings Ceetak offers a range of innovative 2-shot (or multi-shot) custom components. These parts allow integration of several functional aspects to give cost, ease of assembly and product reliability advantages. Material combinations are optimised to meet application demands. Standard and Custom Face Seals Ceetak offers an array of standard and custom face seals for static (and some) dynamic applications. Manufactured to meet the demands of irregular groove dimensions and wide tolerancing on mating parts, they are available in a range of materials for critical vibration and sealing requirements. Metal Seals and Gaskets Ceetak provides metal seals in a variety of base metals and plating finishes, available as resilient metal seals and metal crush gaskets in a wide range of shapes and sizes. Metal seals are ideal for high temperature, high vacuum, broad chemical and low extractable applications. Composite Seals Ceetak s composite seals are rubberto-metal or rubber-to-plastic custom engineered sealing solutions. These seals allow for the integration of multiple components with unique sealing geometries, which provide ease of assembly and reliable service, resulting in a lower overall cost. PTFE FlexiSeals Our full line of spring-energised PTFE lip seals are used in rod, piston, face and rotary sealing applications. FlexiSeals are typically used in areas where elastomeric seals cannot meet the frictional, temperature or chemical resistance requirements of the application.

5 Material Certifications Ceetak continually develops new materials according to Life Science customer specifications in conjunction with our global manufacturing and material development centres. An overview of the types of materials and approvals available in each one are shown in the tables below: Control Definition Nitrile/Hydrogenated Nitrile (NBR/HNBR) Good mechanical properties and wear resistance. Temp range -40 C to 120 C -35 C to 150 C (HNBR) Ethylene Propylene (EPDM) Good ozone, water and radiation resistance. Organic and polar solvent resistant. Temp range -50 C to 120 C Fluorocarbon (FKM) Good high temperature & chemical resistance. Suitable for aromatic hydrocarbons, vacuum & ozone. Temp range -25 C to 200 C Pharmacopeia Biocompatibility of Medical Devices Administration Ins. for Material Research & Ins. for Risk Assessment Control Control Definition Perfluoroelastomers (FFKM) Silicone (MVQ) Excellent chemical & high temperature resistance. Suitable for steam, low weight vacuum loss. Temp range -10 C to 320 C Heat age resistant, low temperature, ozone, weather and toxicologically stable. Temp range -50 C to 230 C Pharmacopeia Biocompatibility of Medical Devices Administration Ins. for Material Research & Ins. for Risk Assessment Definition Polyurethane (TPU) Thermoplastic Elastomers (TPE) Pharmacopeia Excellent tear and wear resistant properties. Oxygen and ozone resistance. Aliphatic hydrocarbon resistant. Temp range -45 to 120 C Good ozone, weather and mechanical properties, good co-polymerisation. Temp range -40 C to 100 C Biocompatibility of Medical Devices Administration Ins. for Material Research & Ins. for Risk Assessment

6 Material Certifications Ceetak continually develops new materials according to Life Science customer specifications in conjunction with our global manufacturing and material development centres. An overview of the types of materials and approvals available in each one are shown in the table below: control Definition Polytetrafluorethylene (TFE/PTFE) Excellent chemical resistance, low friction and wide temperature range. Creep strength (with fillers). Temp range -269 C to 320 C Polyetheretherketone (PEEK) Excellent temperature, chemical and pressure resistance. Low friction, dimensional stability. Temp range -120 C to 250 C Pharmacopeia Biocompatibility of Medical Devices Administration Ins. for Material Research & Ins. for Risk Assessment Clean Room Manufacturing Conditions Today s medical products are subject to strict demands regarding hygiene and cleanliness - in production of many parts clean-room manufacturing conditions are required. Clean room classes are established according to quality standards such as VDI 2083, Blatt 1 and clean rooms are monitored according to DIN ISO 14644, Part 1. Our manufacturing facilities specialise in the production of O-rings and moulded parts for the Life Sciences market and (on request) even large volumes can be manufactured under clean room conditions. Depending on the particular requirement, individual production steps can be offered up to clean room class 100 (see table below). FS209E ISO14644 Production step Cleanroom Class Vulcanisation Deflashing Washing & Cleaning Inspection Packaging & Special Inspection Ceetak Ltd Head Office: Fraser Road, Priory Business Park, Bedford, MK44 3WH Tel: Fax: Web: info@ceetak.com Ceetak Aberdeen: Block 1, Unit 13, Souterhead Rd, Altens Industrial Estate, Aberdeen, AB12 3LF Tel: Fax: