THERMOFORMING-FILM PENTAMED® PETG MD

Product catalog summary

Product Description
The THERMOFORM-FILM PENTAMED® PETG MD is designed for medical and pharmaceutical packaging, complying with legal and normative requirements. It is available in thicknesses from 0.25 mm to 1.20 mm with specific tolerances and comes in blue tinted, white, and transparent colors.

Typical Application
Used for thermoformed blister trays in medical packaging.

Functional Characteristics
The film offers very good transparency, excellent thermoforming properties, toughness, no silicone coating, high resistance to sterilization, and includes an antiblock for destacking.

Applicable Sterilization Processes
Suitable for gamma sterilization (25kGy – 50kGy), E-beam sterilization, and EO sterilization with recommended parameters of max. 54°C at max. 50% relative humidity.

Storage Conditions
Store in original packaging in a clean, dry environment away from direct light and heat. Avoid storing with solvents or chemicals. Recommended storage temperature is 10°C – 30°C with relative humidity below 50%.

Shelf Life
The material has a shelf life of 2 years from the date of manufacture if stored correctly. For use in sterile barrier systems, users must validate the packaging system's shelf life according to DIN EN ISO 11607-1:2020.

Processing Conditions
Intended for medical and pharmaceutical packaging, requiring standard environmental conditions for processing. Process validation is necessary to determine manufacturing parameters.

Technical Specifications
Main components include Copolyester EastarTM 6763 with additives like SUKANO® G dc S239 for antiblock and color additives for tinting. Physical properties include a density of 1.26-1.30 g/cm³, tensile strength of 40 MPa, and a glass transition temperature of 80°C.

Biocompatibility
A cytotoxicity test according to ISO 10993-5 showed no cytotoxicity.

Certifications and Conformity
MEDIPACK AG is not a legal manufacturer under MDR EC 2017/745 but supports customers in compliance. The company ensures its supply chain is free of conflict minerals, complying with Regulation 2017/821/EU.

Catalog excerpts

Datenblatt / Datasheet THERMOFORM-FOLIE PENTAMED® PETG MD THERMOFORMING-FILM PENTAMED® PETG MD Das Produkt ist fur die Herstellung medizinischer und pharmazeutischer Verpackungen entwickelt worden. Die Materialien entsprechen den gultigen gesetzlichen und normativen Anforderungen. The product is designed for the manufacture of medical and pharmaceutical packaging. The materials comply with the applicable legal and normative requirements. Basic Data Grunddaten Material Typische Anwendung Thermotiefgezogene Blisterschale fur die medizintech-nische Verpackungen._ sehr gute Transparenz hervorragende Thermoform - Eigenschaften keine Silikonbeschichtung hohe Sterilisationsresistenz fur die Entstapelung ist ein Antiblock integriert Thermoformed blister tray for medical packaging. Functional Characteristics very good transparency excellent thermoforming properties high resistance to sterilisation an antiblock is integrated for destacking Geeignete Sterilisationsmethoden Gamma Sterilisation: 25kGy - 50kGy E-Beam-Sterilisation EO-Sterilisation, empfohlene Sterilisationsparameter: max. 54°C bei max. 50%rH Applicable Sterilization Process Gamma sterilization: 25kGy - 50kGy E-beam sterilization EO sterilization, suggested sterilization parameters: max. 54°C at max. 50%rH Lagerbedingungen Vor direktem Licht geschutzt und in der Originalverpa-ckung in einem sauberen und trockenen Raum aufbe-wahren. Nicht direkter Hitze aussetzen. Nicht im glei-chen Raum mit Losungsmitteln oder Chemikalien la-gern. Storage in original packaging in a clean, dry environment away from direct exposition to light. Avoid any direct heat. Not to be stored together with solvents or chemicals in the same room. Recommended Storage Conditions Muhlentalstrasse 184-188 8200 Schaffhausen / Switzerland [email protected] / www.medipack.ch

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Datenblatt / DatasheetTHERMOFORM-FOLIE PENTAMED® PETG MD THERMOFORMING-FILM PENTAMED® PETG MDHaltbarkeit Das Material hat bei richtiger Lagerung gemass den Be-dingungen aus diesem Datenblatt eine Haltbarkeits-dauer von 2 Jahren nach Herstelldatum. Bei Verwendung des Produkts als Bestandteil eines Ste-rilbarrieresystems, muss der Anwender selbst die Haltbarkeit des Verpackungssystems gemass der DIN EN ISO 11607-1:2020 fur seine spezifische Anwendung in einer Validierungsstudie nachweisen. Verarbeitungsbedingungen Das vorliegende Material ist als Verpackungsmaterial fur medizintechnische- und oder...

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Datenblatt / DatasheetTHERMOFORM-FOLIE PENTAMED® PETG MD THERMOFORMING-FILM PENTAMED® PETG MDPhysikalische Eigenschaften Physical Properties Property *Maschinenrichtung (MD): Langsrichtung / machine direction: Longitudinal direction ** Wert bei einer Folien Dicke von 0.5mm / value with a film thickness of 0.5mm Biokompatibilitat Fur das vorliegende Verpackungsmaterial wurde eine Zytotoxizitatsprufung (gem. ISO 10993-5) durchge-fuhrt und es wurde keine Zytotoxizitat nachgewiesen. Biocompatibility A cytotoxicity test (acc. ISO 10993-5) was carried out for this packaging material and no cytotoxicity...

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