Medical device manufacturers must balance regulatory compliance, production efficiency, and sustainability goals, all while maintaining the highest quality standards. ELIX Polymers' E-LOOP pre-coloured ABS for medical devices offers a comprehensive solution to these challenges.
By utilising recycled feedstock for medical devices and advanced emulsion technology, E-LOOP delivers ISCC+ medical-grade ABS that streamlines manufacturing while significantly reducing environmental impact. Additionally, the pre-coloured material for medical devices comes with:
- Complete biocompatibility certifications
- Consistent colour matching
- Full regulatory documentation
These offer significant improvements on traditional post-colouring procedures.
How can E-LOOP pre-coloured ABS be used in medical devices?
ELIX’s E-LOOP pre-coloured ABS for medical devices is an ideal solution for:
- Infusion systems, such as cannulas, caps, spikes, slide clamps, and roller clamps
- Respiratory devices, such as Dry Powder Inhalers (DPI), Soft Mist Inhalers (SMI) and Metered Dose Inhalers (MDI)
- Autoinjection devices, such as lancing devices, insulin pens, and auto-injection pens
- Medical device casings, such as external housing for the device
- Smart medical devices, such as intelligent respiratory devices, intelligent injectable devices, and wearables that dose and administer medication
ELIX’s database includes a wide range of matched colours for medical-grade ABS. These use FDA and EU-FC approved pigments and additives and offer full regulatory compliance. Additionally, custom colours can be developed specifically for the customer to meet their requirements.
What is the advantage of pre-coloured material for medical devices?
ABS polymerisation companies are normally focused on high volumes and reduced pre-coloured portfolios, obliging device manufacturers to add colour to medical-grade ABS in their own processes. On the other hand, pre-coloured solutions offer a number of advantages.
1. Regulatory and safety assurances
With E-LOOP medical-grade ABS, ELIX already provides the required compliance certifications that refer to the complete material formulation, including all colour pigments. The complete compounds are also already certified for biocompatibility, lessening the need for additional testing by customers.
2. Simplified manufacturing process
The use of pre-coloured material for medical devices streamlines manufacturing, eliminating the need to add colour later on and reducing the risk of manufacturing mistakes.
3. Better colour uniformity and lot-to-lot consistency
Pre-coloured ABS offers a higher level of colour homogeneity than post-colouring, and ELIX assures that every batch will be colour-matched.
4. Better performance for laser marking
ELIX’s M203FC and M205FC materials can be easily laser marked. Specific colour formulations optimised for laser marking can consistently achieve a target colour change and level of contrast over a given colour background that is fully compliant with regulations.
4. Improved patient satisfaction
Patients prefer medical devices that look good, and colour can even improve patient compliance when it helps to differentiate device parts and indicate how to use the device correctly. These goals are easiest to achieve with pre-coloured E-LOOP ABS.
What is the regulatory status of ELIX pre-coloured ABS?
Thanks to rigorous periodic testing, ELIX’s pre-coloured ABS for medical devices assures more regulatory compliance than materials which are coloured later in the manufacturing process. These tests take place at the highest possible colour concentrations to ensure that all possible pigment concentrations will meet regulatory standards.
All E-LOOP pre-coloured material for medical devices is biocompatible according to ISO 10993-1. These materials demonstrate long-term hydrolytic stability, even at elevated temperatures, and resistance to a broad range of chemicals and body fluids. They are durable and maintain their mechanical properties through sterilisation via gamma radiation and ethylenoxide.
More compliance information can be seen in the following table:
| Regulatory compliance | ELIX M203FC | ELIX M205FC |
|---|---|---|
| General | ||
| DMF – Type III | 25288 | 25284 |
| Letter of Authorisation* | ✓ | ✓ |
| Pharmacopoeia | ||
| Europe – EU, 7th Edition Chap. 3.2.2 “Plastics Containers and Closures” | ✓ | ✓ |
| US – USP Class VI | ✓ | ✓ |
| Up to 30 days human contact duration | ✓ | ✓ |
| Biocompatibility – ISO 10993-1 | ✓ | ✓ |
| Biocompatibility tests (e.g., Cytotoxicity, In-Vitro Hemocompatibility) | ✓ | ✓ |
| Food Contact | ||
| EU Regulation No. 10/2011 | ✓ | ✓ |
| FDA regulation 21 CFR | ✓ | ✓ |
| Germany, BfR – Recommendations | ✓ | ✓ |
| Others | ||
| REACH compliant products | ✓ | ✓ |
| RoHS 2011/65/EU compliant products | ✓ | ✓ |
| BSE/TSE absence of risk | ✓ | ✓ |
| Non-use of endocrine effective substances | ✓ | ✓ |
* Upon request
What support does ELIX offer medical device manufacturers?
ELIX is committed to quality assurance, product stewardship, and regulatory support for the medical industry.
Medical device manufacturers can trust that E-LOOP materials have been thoroughly vetted, as ELIX procedures include:
- A special raw material supplier homologation process
- Dedicated quality management team
- Inward testing on all raw materials
- Intermediate selection during manufacturing
- Extended testing procedure on final products
- Adherence to Good Manufacturing Practices (GMP)
Furthermore, ELIX can provide clients with:
- Letter of Authorisation (LoA) to access the FDA material DMF#
- Registration of new ABS colours in the FDA DMF#
- Release of declarations and certifications
- Information on Pharmacopeia tests
- Documentation for Medical device approval
- Other certificates such as REACH, RoHS, and so forth
Customers of ISCC+ medical-grade ABS can expect consistent product formulations, with a no-change agreement for up to 3 years, and extended sample storage for 3 years.
ELIX monitors the complex and changing medical regulatory framework across its service areas, and optimises formulas to comply with actual legislation and biocompatibility ranges.
How can E-LOOP pre-coloured ABS help meet manufacturers’ sustainability goals?
E-LOOP provides recycled and bio-based feedstocks for medical devices, so that manufacturers can decrease the use of virgin materials. This recycled feedstock originates from mixed plastic waste, end-of-life tyres, used cooking oil and organic waste. Mixed plastic waste or end-of-life tyres are chemically recycled to recover pyrolysis oil. Used cooking oil and organic waste follow a hydrogenation process to obtain HVO (Hydrogenated Vegetable Oils). Pyrolysis and HVO oils can substitute the fossil oils extracted from the ground and used as input feedstock for the existing petrochemical steam crackers. Further processing generates bio-circular and/or circular styrene, which is then polymerised and compounded into E-LOOP ABS.
E-LOOP is ISCC+ certified, with traceability throughout the supply chain. The various products in the E-LOOP line can be made with different levels of bio-circular feedstocks, allowing manufacturers to choose the ABS option most suited to their needs with full transparency. These feedstocks include bio-circular acrylonitrile from biogas, tall oil, and agricultural waste; bio-styrene from used cooking oil and organic waste; and bio-butadiene from used cooking oil and organic waste. Many E-LOOP products also include chemically recycled material from used tyres.
The higher the percent content of sustainable and recycled feedstock in the ABS, the more CO₂ emissions are reduced. In the case of ELIX A-LOOP ABS CR100 made from used tyres, biogas, agricultural waste, and used cooking oil, this can result in a CO₂ footprint reduction as high as 98%. For ELIX E-LOOP ABS CR1000 made completely from bio-circular materials, the reduction in carbon footprint can actually be 150%, due to carbon capture in the agricultural growth stage.
These lifecycle assessments are calculated according to ISO 14040 and ISO 14044 methodology, and verified through ISCC+ certification. Medical device manufacturers in search of sustainable solutions can make significant progress by incorporating E-LOOP products.
Is ISCC+ medical-grade ABS right for your business?
As an E-LOOP distributor, IMCD is well-versed in the ways that these products can benefit medical device manufacturers, and how pre-coloured medical-grade ABS can be incorporated into existing production processes.
ELIX Polymers is a leading European manufacturer of ABS resins and derivatives, with technical expertise in product formulation and colour development for the healthcare industry.
We can offer further information about ELIX’s medical ABS product line, and how it could be useful to your organisation. Please don’t hesitate to reach out to your IMCD representative for more information.
