Product Lines: ColorRx®

 

Thermoplastic Compounds and Master Batches for the Medical Device and Healthcare Industries


Americhem offers a full line of thermoplastic resins for medical device applications under our proprietary ColorRx® product line. All resins intended for use in body-contact applications have been tested for biocompatibility. Americhem also provides custom compounds in resin grades specified by the customer. Essentially all thermoplastic resins, with the exception of PVC, are availalbe ranging from polyethylene and polypropylene to high-performance resins such as PPSU and PEEK.

The ColorRx product line includes a wide range of thermoplastic elastomers (TPE's) ranging from 50 Shore A hardness to 70 Shore D, some of which are transparent. Grades are available for over-molding to achieve "soft-touch" surfaces, and for tubing applications, seals and closures, bags, bottles, and films.

A full line of resins for device enclosures and housings that do not require biocompatibility is also available, including resins with enhanced resistance to chemical agents to meet today's more demanding sanitizing requirements.

Catheter and Medical Tubing Applications

Americhem offers a wide range of engineered compounds for catheter and medical tubing applications, including Pebax®, Polyamide 11 and 12, TPU's, HDPE, LDPE, and fluoropolymers. These compounds are available with radiopacifiers, lubricants, and antimicrobial agents.

Resin Selection and Development Support

Americhem's staff of Application Engineers and Polymer Scientists assists customers in choosing the right resin with the required properties for new applications. Biocompatible grades in essentially every thermoplastic resin type can be specified. Americhem's laboratory compounding and material testing facilities are available for customer trials, and customer personnel are able to work alongside Americhem staff. With this level of support, Americhem can help expedite the new device development process.

ColorRx® Product Line

Biocompatible grades, indicated by an RX suffix in the grade name, are produced using resins that have been tested by the manufacturer against either USP Class VI or ISO 10993-1 protocols. Colorants have also been tested for biocompatibility. This allows device manufacturers to proceed with their development process with a high level of confidence that the device itself will pass final biocompatibility testing.

ColorRx grades with a NB suffix are intended for equipment enclosures and housings. These grades have not been tested for biocompatibility.

White Paper:  Selection of Plastic Colorants for Medical Applications

Antimicrobial Protection and Other Functional Properties

Antimicrobial protection is achieved by the addition of well-proven silver ion or organometallic technology. Bacterial surface count reductions on the order of log 3-4 or more can be achieved, as measured by the standard JIS Z2801 test.

Other functional properties are available in the ColorRx line, such as radiopacity using several different materials (barium and bismuth compounds, tungsten) and radiation sterilization.

Additional information is available on request for the efficacy of antimicrobial formulations as well as regulatory considerations for use of antimicrobial agents. Americhem makes no public health claims for articles made from ColorRx resins containing an antimicrobial agent. Health-related claims for medical devices must be approved by the FDA and require extensive supporting data. In the absence of FDA approval, EPA regulations for antimicrobials allow claims only for protection of the article itself from deterioration, discoloration, or odor development caused by the growth of microorganisms on the article.

Innovations Briefs video presentation - Silver Ion Antimicrobial Agents in the Battle Against Hospital Acquired Infections - by Phil Dix, Medical Marketing & Development Manager, presented at the MD&M East 2011 Trade Show

Powerpoint slide presentation - Silver Ion Antimicrobial Agents in the Battle Against Hospital Acquired Infections - by Phil Dix, Medical Marketing & Development Manager

Change Management for the Medical Device Market

All ColorRx medical product formulas used in body-contact applications are "locked".  Americhem will not change a ColorRx medical formula in any way unless forced to do so by a formula change or product discontinuation by a raw material manufacturer. Americhem works with only highly regarded material suppliers who understand the needs of the medical market and are committed to providing lengthy advance notice of formula changes or product discontinuations.

Regulatory Support

Americhem supports our customers' regulatory submittals with information on our colorant systems and resin selections. This is of growing importance given the FDA's increasing emphasis on colorants as additives.

Quality at Americhem

The culture at Americhem emphasizes quality in all we do. Our state-of-the-art manufacturing equipment, first-rate laboratory, highly trained technical staff, very experienced and motivated workforce, and robust Quality Management System combine to assure that we meet our customers’ requirements and expectations. Our Quality Management System complies with both ISO 9001:2008 and ISO 13485:2003, the worldwide GMP standard for the design and manufacture of medical devices. Americhem is one of the first North American compounders to achieve ISO 13485:2003 certification for thermoplastic resins used in medical devices.

Americhem Policy for Medical Device Applications

Where applicable, Americhem uses biocompatible ingredients in the compounding of materials intended for healthcare applications that require biocompatibility.  Americhem compounds are not produced for, nor are they promoted for, or intended to be used in devices that are to be implanted in, or come in contact with the human body, its tissues, or fluids for periods exceeding 30 days, or that are critical components of medical devices that support or sustain human life. It is solely the responsibility of the finished product or device manufacturer to determine the acceptability of Americhem compounds in all applications involving contact with the human body, its tissues, and fluids, or fluids that enter the body.

AMERICHEM MAKES NO WARRANTIES, EXPRESS OR IMPLIED, CONCERNING THE SUITABILITY OF ANY OF ITS PRODUCTS FOR USE IN MEDICAL APPLICATIONS, AND AMERICHEM DISCLAIMS ANY AND ALL LIABILITY FOR LOSSES OR DAMAGES THAT MAY RESULT FROM THE USE OF ITS PRODUCTS IN SUCH BODY CONTACT APPLICATIONS.

ColorRx® Resins- Your prescription for expedited device development!