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High-performance medical elastomers vital for safety
Source:CPRJ Editorial Team    Author:By Sofie Chong    Date:17.Dec.2019

The new VDI guideline releases

Intended as a guideline for manufacturers and users of plastics for medical products, the VDI guideline 2017 regulates the requirements qualified MGPs have to meet, from basic requirements to formulation consistency and change management through to withdrawal terms.

The VDI 2017 is an important first step toward harmonizing the range of performance that a medical grade plastic must fulfill, and it creates obligatory guidance in the communication between manufacturers of MGPs and OEMs and/or the manufacturers of medical, pharmaceutical and in vitro products.

The new guideline explicitly provides scope for the respective material suppliers and their customers to make broader arrangements. One of the main consequences of VDI 2017 is a restriction of the range of raw materials and auxiliary agents permitted for MGPs, which means that some manufacturers have to adjust their materials formulations.

The new guideline also regulates the controlled continuity of the composition of specific compounds based on a documented change control management system, which ensures that the compounds are suitable for use for a long-term period and makes costly checks unnecessary.

Certified compounds for TPE/PA composite applications

With its new MC/AD/PA THERMOLAST M series, KRAIBURG TPE launched one of the first thermoplastic elastomers (TPEs) that not only hold certifications for healthcare applications in accordance with EU and FDA standards but can also be combined directly with polyamides.

The MGP-compliant TPE compounds that have been available in the market so far do not provide adhesion to polyamides (PA) and thus cannot be used for many sophisticated applications.

KRAIBURG TPE’s new MC/AD/PA THERMOLAST M series closes this gap. The compounds are fully certified and suitable for a variety of attractive medical devices, including those used for in vitro diagnostics.

The compounds of the new TPE series meet the recently adopted VDI 2017 guideline that regulates the criteria for MGP-compliant materials – from basic requirements to formulation consistency and modification management. They comply with the Commission Regulation (EU) No. 10/2011 and the Code of Federal Regulations Title 21 (21CFR) of FDA.

KRAIBURG TPE further ensures alignment with the new VDI 2017 that the manufacturing processes are also included in the change control management system and the original formulation of such a compound will remain available in parallel with the new type for minimum 24 months after a possible change or withdrawal notification.

The new TPEs also meet the requirements for human compatibility in accordance with the specifications of the ISO 10993-5 and 10993-11 standards. All types can be sterilized using beta or gamma radiation, or ethylene oxide (EtO).

Like all THERMOLAST M products, the MC/AD/PA compounds are free of latex, PVC, and phthalates, and they are produced without the use of heavy metals. Types with a hardness range between 60 and 70 Shore A are currently available. 

Breathable PU materials for wound care and wearables

Covestro has developed an array of solutions for medical care. For all layers of modern wound dressings, Covestro offers holistic material solutions Polyurethane (PU) adhesive components from the Baymedix A range characterized by breathability – an important prerequisite for moisture management in advanced wound dressings. The adhesive system can also be easily removed from the skin without sticking to the hair (low trauma).

Covestro Baymedix FP also provides polyurethane raw materials for foams with absorption and retention properties. By directly coating the carrier film with the adhesive system or foam, process and laminating steps can also be saved in production which increases efficiency. Special thermoplastic polyurethane films (TPU) from the Platilon range with a particularly mat surface round off the range.

Wearable electronic patch devices are already being used in a variety of medical applications, including monitoring, diagnostics and drug delivery. They help patients gain greater mobility.

The wearables must be worn on the skin around the clock for a prolonged period of time so they need to be particularly kind to the skin, comfortable, but also adhere firmly to the skin. Among other things, Covestro has developed special breathable TPU films from the Platilon range for this purpose.

The company also supports customers in the manufacturing with a process that allows wearables to be efficiently produced from roll to roll.

Customizable and flexible silicone tubing for implants

Trelleborg has developed a wide range of tubing for medical applications.At the COMPAMED 2019 trade fair held in Düsseldorf, Trelleborg Healthcare & Medical showcased medical silicone tubes for long-term implants.

Due to their biocompatibility and physical resistance, silicone tubes play an important role in medical applications, both as conduits to transport liquid or as insulators for cables and sensors. The products must meet high precision, control and process stability demands, and also be implantable for up to several years.

The tubes from Trelleborg are available in a full range of sizes and are designed jointly with customers to meet their individual application needs.

Trelleborg’s patented GeoTrans technology enables a significantly greater variation in the geometry of tubing, supporting customer-specific designs. For example, one lumen can be separated into two lumen (or two into one) during the extrusion process, eliminating the need for a molded component between the different segments.

Additionally, lumen can be stopped and restarted or the dimensions of the tubing can be changed, which is often necessary for wound drains. Reducing the process steps in manufacturing saves time and decreases potential sources of failure, thereby reducing costs and mitigating risk.

Also on show were Trelleborg’s silicone sheeting and film capabilities. Trelleborg has, in partnership with a customer, developed drug-eluting silicone film, which can be used to treat chronic wounds and burns.

Depending on the medical application, wafer-thin silicone gel films containing active pharmaceutical ingredients are being increasingly used in place of more traditional burn and wound care treatments.

The silicone film can be combined with antibiotics or decongestants, which can potentially replace epidermally applied medication.        

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