PC


PC-0700RX
Product Data|SDS

PC-1000RX
Product Data

PC-1000RXR
Product Data

PC-1010GFRX
Product Data

PC-1030RXGF
Product Data

PC-1300RX
Product Data|SDS

PC-1500RX
Product Data|SDS

PC-1600RX
Product Data

PC-1800RX
Product Data

PC-2000RX
Product Data|SDS

PC-4000RX
Product Data|SDS

PC-2500RXR
Product Data

PC2-1500RX
Product Data

FRPC-1000NB
Product Data

PC-1000NB
Product Data

PC-1500NB
Product Data

PC-2000NB
Product Data
PC/PET

PCT-1200RX
Product Data

PCT-1500RX
Product Data

PCPT-0900CRNB
Product Data

PCPT-1000NB
Product Data

PCPT-1000CFRNB
Product Data

FRPCT-1100RX
Product Data
PC/PBT

PCPB-1000NB
Product Data
ABS

ABS-0500RX
Product Data|SDS

ABS-0600RX
Product Data

ABS-0700RX
Product Data

ABS-0500NB
Product Data

FRA-1100NB
Product Data
PP Random Copolymer


PP2-0190RX
Product Data

PP2-0200RX
Product Data

PP2-0900RX
Product Data

PP2-1000RX
Product Data|SDS

PP2-2700RX
Product Data

PP2-3500RX
Product Data
HIPS

HIPS-0600RX
Product Data

HIPS-0800RX

Product Data|SDS

HIPS-1500RX
Product Data|SDS
Nylon

NY2-1000RX
Product Data|SDS

NY3-1000RX
Product Data

NY4-1000RX
Product Data

NY5-1000RX
Product Data
PBT


PBT-2100RX
Product Data

PBT-5000RX
Product Data
HDPE

PE2-0100RX
Product Data

PE2-0200RX
Product Data|SDS

PE2-0400RX
Product Data

PE2-2000F
Product Data

PE2-2000RX
Product Data

PE2-4000RX

Product Data|SDS

LDPE

PE3-0200RX
Product Data
Copolyester

PET-1000RX
Product Data

PET-1100RX
Product Data

PET-2000RX
Product Data
Acrylic (PMMA)

ACR-0100HIRX
Product Data

ACR-0300MIRX
Product Data

ACR-0300HIRXG
Product Data

ACR-0300RX
Product Data

ACR-0400RX
Product Data

ACR-1300MIRXG
Product Data

ACR-1500RX
Product Data
PEEK

PEEK-3000RX
Product Data
PEI

PEI-0900RX
Product Data

PEI-1600RX
Product Data
POM Homopolymer

POM1-1000RX
Product Data

POM1-2000RX
Product Data

PP Impact


PP3-5500F
Product Data

PPE


PPE-0800RX
Product Data

PPE-1000RX
Product Data

PS


PS-1400RX
Product Data
TPE


TPES5500-40A-RX
Product Data

TPES5500-50A-RX
Product Data

TPES5500-60A-RX
Product Data

TPEV7500-45A-RX
Product Data

TPEV7500-55A-RX
Product Data

TPEV7500-65A-RX
Product Data

TPEV7500-90A-RX
Product Data

TPEU9500-70A-RX
Product Data

TPEU9500-90A-RX
Product Data

TPEU9500-65D-RX
Product Data

TPEU9500-75D-RX
Product Data


ColorRx® Antimicrobial Grades

ColorRx® Medical Project Case Studies

Product Regulatory Requests







Product Lines: ColorRx®

 

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


Infinity LTL 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. Infinity LTL 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

Infinity LTL 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

Infinity LTL'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. Infinity LTL's laboratory compounding and material testing facilities are available for customer trials, and customer personnel are able to work alongside Infinity LTL staff. With this level of support, Infinity LTL can help expedite the new device development process.

ColorRx® Product Line

ColorRx resin groups are listed to the right. 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. LTL Color Compounders, LLC 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". Infinity LTL 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. Infinity LTL 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

Infinity LTL 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 Infinity LTL

The culture at Infinity LTL 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. Infinity LTL is one of the first North American compounders to achieve ISO 13485:2003 certification for thermoplastic resins used in medical devices.

Infinity LTL Policy for Medical Device Applications

ColorRx compounds are not designed for, nor are they promoted for or intended to be used in, devices which are to be implanted in or come in contact with the human body, its tissues, or fluids for periods exceeding 30 days, or which are critical components of medical devices that support or sustain human life. Where applicable, LTL Color Compounders, LLC uses USP Class VI or ISO 10993-1 compliant ingredients in the compounding of ColorRx resins intended for applications that require biocompatibility, however, ColorRx compounds have not been tested for biocompatibility. It is solely the responsibility of the finished product or device manufacturer to determine the acceptability of ColorRx compounds in all applications involving contact with the human body, its tissues, or fluids.

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

ColorRx® Resins- Your prescription for expedited device development!