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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.

Red Granules

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.

Blood

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.

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

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

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.

Product range
CHIMEI
CHIMEI
Available in the UK, Ireland, Nordics and Benelux
DUPONT PERFORMANCE POLYMERS
DUPONT PERFORMANCE POLYMERS
Available in the UK, Ireland and Nordics
HEXPOL TPE
HEXPOL TPE
Available in the UK and Ireland
INEOS POLYOLEFINS
INEOS POLYOLEFINS
Available in the UK and Ireland
VERSALIS
VERSALIS
Available in the UK, Ireland and Benelux
Medical

Useful information

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