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Distrupol delivers high-quality thermoplastics to the healthcare industry. These thermoplastics are used in the manufacture of demanding components across many different healthcare segments.

Range:

Distrupol draws on our longstanding experience in materials, application development, technology, safety and regulatory compliance to provide expert support to healthcare product manufacturers, backed by our global polymer supply partners. Depending on the specific application, Distrupol can deliver an appropriate solution from our broad range of standard products, or from our portfolio of medically approved grades, which are differentiated by a greater degree of testing, manufacturing control and regulatory support.

Support:

We can help select a 'fit for purpose' solution for your applications, recommending the most suitable materials. We understand the numerous requirements and considerations specific to the medical industry, enabling you to get it right first time. Our development engineers can also help you with conceptual design, mould flow and tooling, material sampling and process optimisation.

Quality, certification, traceability and confidence:

Authenticity and traceability of materials being used for your components is critical. We can supply you with certificates of conformity and analysis with every delivery, and give you full traceability and the confidence that you, and your moulders, are using the right material that is certified and in specification.

Applications Solutions Sterilisation ISO 10993 Biocompatibility

Auto-Injector Pens Auto-injector pens provide a fast, easy, reliable, safe and repeatable method of injecting medicine. Recent developments in traditionally designed injector pens have pushed design boundaries, with smaller and more compact devices being developed. It ... Read more

Antimicrobial Plastic Microbes are tiny organisms that are almost everywhere. They're found in the air, in soil, in water and even inside our bodies. Existing for approximately 3.5 billion years, microbes have evolved to survive in a huge variety of habitats... Read more

Ostomy Bags An ostomy is a surgery that makes an opening in the skin called a stoma. Stomas can be temporary or permanent and are usually of two types: colostomy and ileostomy. Both are pathways from internal organs to the outside of your abdomen.... Read more

Medical Appliance Surfaces Most hospital electrical equipment relies on flame retardant PC+ABS for the outer housing due to its glossy appearance and good impact strength. However, since the increase in outbreaks of viruses such as Covid-19, hospital maintenance teams must ens... Read more

Stent Fitting Apparatus In the event of restricted blood flow in an artery, it is fairly common practice to fit stents. Stents are comprised of a wire mesh that collapses into a very small diameter when initially inserted. It can then be opened and expanded when the restric... Read more

Medical Equipment

Introducing Medical Grades from ChiMei (MP package) suitable for Class I and Class II medical devices.

Face Mask Mediprene® Medical TPE compounds from HEXPOL TPE are suitable for a wide variety of uses in the medical and pharmaceutical market including face masks. Mediprene® TPE grades are based on raw materials that comply with the TPE-related ... Read more

Primary Ridged Packaging INEOS Eltex® MED Polypropylene grades are suitable for a wide range of applications including inhaler parts, caps and closures, tubes and primary packaging of medical and pharmaceutical applications. Specific advantages and features... Read more

Dose Counting Inhalers Inhalers are common for treatment of respiratory illnesses. They deliver steroids (e.g. prednisone) to treat inflammation and/or bronchodilator, to open up the airways. Modern asthma inhaler designs have adapted to include dose counting features. ... Read more

Stent Delivery Systems In the event of restricted blood flow in an artery, it is fairly common practice to fit stents. Stents are comprised of a wire mesh that collapses to a very small diameter when initially inserted. It can then be opened and expanded when the restricte... Read more

Patch Pump Components Patch pumps are a recent innovation which enable medicine to be automatically administered to a patient. The product consists of an electronically driven pump which is controlled by a handheld unit or third-party device (e.g. a mobile phone). Taking ... Read more

Medical Tubing Clamps Polymer medical tubes are used to transport a variety of fluids e.g. liquid drugs, parenteral fluid, water or blood. Sometimes the fluid flow needs to be stopped and to do this, a clamp and/ or clip is required to restrict the tubing and halt the flo... Read more

Prosthesis & Patient Assistance Prosthesis has been traced all the way back to the Ancient Egyptians, dated between 950-710 BCE. Despite this being an incredible feat for the time, it is safe to say that medical technology has evolved enormously since then. Prosthetics replace a... Read more

Sleep Apnoea Masks Sleep Apnoea is a sleeping condition marked by abnormal breathing during sleep. People with sleep apnoea have multiple extended pauses in breath when they sleep, which causes gasping, snoring and low-quality sleep. It also affects the body's supp... Read more

Auto Injector Dampeners Auto-injector pens provide a fast, easy, reliable, safe and repeatable method of injecting medicine. Allergies are the most well-known reason for carrying and using an auto-injector pens. In this instance, they contain adrenaline (epinephrine) which ... Read more

Inhaler Components Electrical connectors are a very broad type of electrical component that connects wires, cables and boards to many other electrical components to complete / continue electrical lines. There are various, extensive standards are regulations involved wi... Read more

Fluid Sample Tubes When blood and other fluids need to be collected in medical environments for testing, they are collected and transported in these familiar tubes. The lids are coloured according to the samples being collected - and it is this part of the applica... Read more

Breathable Respiratory Smoothbore Circuits Medical tubing is used for delivering and removing air, fluid and medication to and from a patient. Respiratory tubing specifically supports a patient to be able to breathe in oxygen and breathe out carbon dioxide. Hytrel® is used in respiratory ... Read more

USP class VI
European Pharmacopeia Approved
ISO 10993
Drug Master File listed
Food Contact Approved
BPA free
2 Year notification of change
Manufactured to GMP practices

Worldwide manufacturing locations
Colour solutions
Flexible materials
Tough materials
Clear materials
PVC replacement
Specialised bonding grades
Specialist tubing grades – solvent bondable

Sterilisation Methods

Autoclave Steam Sterilisation

Steam sterilisation, or autoclaving, is a widely used method. It is comparatively easy to control (environmentally friendly) and can be performed with relatively low-cost equipment. An autoclave combines heat and moisture at elevated pressures. Heat sterilisation of medical instruments or components with the presence of moisture significantly speeds up heat penetration (steam sterilisation). The time and temperature for sterilisation depends on pressure and the type of microorganisms to be inactivated. Typical process conditions are 20 min at 121°C or 5 min at 134°C.

Ethylene Oxide (EtO) Sterilisation

EtO sterilisation is the gaseous method of sterilisation involving the highly diffusive, permeable and toxic EtO gas. The use of EtO sterilisation evolved for sterilising heat and moisture-sensitive medical devices and or devices containing electronic components. The processes of EtO sterilisation involve several stages of gas removal: humidification, EtO exposure and air washes. Process pressures are close to vacuum and temperatures used are circa 50°C. Many plastic materials are compatible with EtO sterilisation.

Plasma Sterilisation

Plasma is a gas sterilisation method where different gases can be used, but Hydrogen Peroxide is the most common. Plasma can be considered were an alternative to EtO is required or the high sterilisation temperatures of Autoclave are not suitable. The plasma sterilisation process is safe and easy to use and is typically used for devices that cannot be sterilised with high heat.

Gamma Ray Sterilisation

Sterilisation by gamma radiation uses the radioisotope Cobalt 60 as its energy source. Items for sterilisation pass the radiation field where gamma rays pass readily through plastics and kill bacteria by breaking the covalent bonds of bacterial DNA. They are measured in units called kiloGrays (kGy). There is no heat or moisture generated during the process and consequently, there is no resulting heat stress and condensate drainage. Most importantly, there is no residual radioactivity after irradiation.

Electron Beam Sterilisation

The electron beam sterilisation process begins with an electron beam accelerator to create a powerful beam of electrons. The beam is scanned back and forth to create a curtain of fast electrons ensuring a uniform dose of radiation to objects passing the beam. E-beam sterilisation destroys all types of pathogens including viruses, fungi, bacteria, parasites, spores, and molds.

ISO 10993 – Explained

The International Organization for Standardization (ISO) was established to determine uniform worldwide standards. ISO developed a standard for biological evaluation of medical devices - ISO 10993 - in 1995, which is a 20-part standard used to evaluate the effects of medical devices and their component materials on the body.

The most influential guideline for biocompatibility is the first part of this standard, “ISO 10993- Part 1: Evaluation and Testing,” which provides a methodology for choosing the proper biological evaluation test program.

From here it is possible to determine also which test program to utilise depending on the device category of which there are three: Surface, External Communicating and Implant, and the exposure period of the material: Limited (<24 hours), Prolonged (24 hours to 30 days) and Permanent (>30 days). Typically ISO 10993-Part 5 is the most relevant to polymers covering cytotoxicity similar to USP monograph <87>.

ISO Part	Title
1	Evaluation and testing
2	Animal welfare requirements
3	Tests for genotoxicity, carcinogenicity and reproductive toxicity
4	Selection of tests for interactions with blood
5	Tests for in vitro cytotoxicity
6	Tests for local effects after implantation
7	Ethylene oxide sterilisation residuals
8	Clinical investigation of medical devices
9	Framework for identification and quantification of potential degradation products
10	Tests for irritation and delayed type hypersensitivity
11	Tests for systemic toxicity
12	Sample preparation and reference materials
13	Identification and quantification of degradation products from polymeric medical devices
14	Identification and quantification of degradation products from ceramics
15	Identification and quantification of degradation products from metals and alloys
16	Toxicokinetic study design for degradation products and leachables
17	Establishment of allowable limits for leachable substances
18	Chemical characterisation of materials
19	Physico-chemical, morphological and topographical characterisation of materials
20	Principles and methods for immunotoxicology testing of medical devices

ISO 10993 Device Categories

Device Categories	Body Contact	Examples
Surface Devices	Skin	Electrodes, external prostheses, fixation tapes, compression bandages, monitors of various types
	Mucous Membrane	Contact lenses, urinary catheters, intravaginal and intraintestinal devices (stomach tubes, sigmoidoscopes, colonoscopes, gastroscopes), endotracheal tubes, bronchoscopes, dental prostheses, orthodontic devices, IUDs
	Breached or Compomised Surfaces	Ulcer, burn and granulation tissue dressings or healing devices, occlusive patches
External Communication Devices	Blood Path Indirect	Solution administration sets, extension sets, transfer sets, blood administration sets
	Tissue/ Bone/Dentin Communicating	Laparoscopes, arthroscopes, draining systems, dental cements, dental filling materials, skin staples
	Circulation	Intravascular catheters, temporary pacemaker electrodes, oxygenators, extracorporeal oxygenator tubing and accessories, dialysers, dialysis tubing and accessories, hemoadsorbents, immunoadsorbents
Implant Devices	Tissue/Bone Implant Devices	Orthopedic pins, plates, replacement joints, bone prostheses, cement and intraosseous devices, pacemakers, drug supply devices, neuromuscular sensors and simulators, replacement tendons, breast implants, artificial larynxes, subperiostealimplants, ligation clips
Implant Devices	Blood	Pacemaker electrodes, artificial arteriovenous fistulae, heart valves, vascular grafts, internal drug delivery catheters, ventricular assist devices

Medical & Biocompatibility Tests

What is Biocompatibility?

It is a material’s lack of interaction with living tissue or a living system by not being toxic, injurious, or physiologically reactive, and not causing immunological rejection.

Ultimately, a material’s chemical components will not cause the patient harm. No single test may be sufficient to define biocompatibility.

Two common test regimens are used to measure biocompatibility, United States Pharmacopeia (USP) and International Organisation for Standardisation (ISO), tests for biological evaluation of medical devices.

What is USP Class VI?

The United States Pharmacopeia (USP) is an independent organisation that established a set of standards to ensure the quality of medicines and health care technologies. USP protocols are used to classify plastics in Classes I - VI, based on end use, type and time of exposure of human tissue to plastics, of which Class VI requires the most stringent testing of all the six classes.

Systemic toxicity tests are used to determine the irritant effect of toxic leachables present in extracts of test materials.
Intracutaneous tests are used to assess the localised reaction of tissue to leachable substances.
Implantation tests are used to evaluate the reaction of living tissue to the plastic.

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