Copolyester PCT-G medical grade

TECADUR MT

TECADUR MT TR natural (PCT-G) is a biocompatible, high performance medical grade plastic made from Eastman Tritan™ copolyester resin. PCT-G is an amorphous polymer with excellent appearance and clarity. This transparent plastic has many outstanding characteristics such as superior toughness, good heat resistance and hydrolytic stability, as well as very good chemical resistance. In addition, PCT-G polymers offer very high gamma sterilization stability with no noticeable color change post exposure. TECADUR MT TR will also withstand exposure to ETO and E-beam sterilization techniques.

Users will find a fit for TECADUR MT TR natural in applications that require low extractables such as diagnostic and chemical analysis equipment, parts needing biocompatibility in contact with blood and tissue for periods less than 24 hours, or situations calling for a combination of chemical resistance and clarity. Typical applications might be manifold blocks for life science or analytical equipment, single use mechanical components for bio pharma processing, dental appliances, or various single use medical device components such as respirators.

BIOCOMPATIBILITY

TECADUR MT TR natural is intended for the use in medical applications that require biocompatibility with limited contact with skin and tissue for up to 24 hours, and, where applicable, indirect contact with blood.
A preliminary screening has been performed on typical production lots of TECADUR MT TR natural to estimate the compatibility of the material with the solvents in the BPOG Standard Extractable Protocol. TECADUR MT TR stock shapes are tested for biocompatibility according to ISO 10993.

The Eastman Tritan copolyester resin is tested according to ISO 10993 and USP Class VI. Information on this testing is available.

KEY CHARACTERISTICS

The material has high impact properties, and excellent clarity without the drawback of BpA additives. In particular, PCT-G also offers good chemical resistance, color stability, and heat resistance. Other properties include:

Resistance to ETO sterilization with good color stability
Resistance to e-beam and gamma sterilization also with color stability
Excellent hydrolytic stability
Outstanding impact resistance

GAMMA STERILIsATION RESISTANCE

One way to eliminate bacteria from a medical device is to subject that device to gamma irradiation from a cobalt-60 source. There is a high level of penetration provided by gamma irradiation at relatively low dosages without the potentially negative aspect of a lot of heat being generated. TECADUR MT TR has the ability to withstand relatively high doses of gamma rays without the polymer’s molecular weight, physical, optical or color properties being significantly affected.

A typical dose of gamma irradiation might be 25 to 50 kGy (2.5 to 5 M Rads). TECADUR MT TR’s PCT-G base polymer has been sterilized up to 100 kGy without significant property loss.

Testing for Single-Use Systems

BPOG testing is important for materials that may be used in biopharmaceutical applications. An acronym for BioPhorum Operations Group, BPOG offers guidelines for pharmaceutical end use products that are designed to evaluate a material's compatibility with certain commonly used solvents. The guideline is referred to as the "Standardized Extractables Testing Protocol for Single-Use Systems in BioManufacturing".

TECADUR MT TR MATERIALS

Ensinger's PCT-G medical grade TECADUR MT TR natural is available in many standard sizes from stock in both rod and plate.

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TECADUR MT TR natural

TECADUR MT TR natural is made from Eastman Tritan copolyester resin, and is a clear, high impact resistant plastic, with very low extractables under various solvents.

Manifold Block

made of TECADUR MT TR natural

Manifold Block in bioprocessing

In the manufacture of chemical fluid handling equipment, it is often necessary to machine parts that act as junctions between components in the fluid handling system in order to regulate fluid flow. Ideally they are transparent in order to verify this fluid flow. They must have excellent chemical resistance, so as to not modify or introduce any leachable compound or chemical into the fluids they are handling.