This is the free Material Data Center Datasheet of Ultraform® N2320 003 PRO AT - POM - BASF

Rapidly solidifying standard grade for injection molding.

Ultraform® PRO offers a comprehensive service package, which supports customers in product development for the medical technology market.

Ultraform® PRO complies with the basic requirements of Pharmacopoeia and Biocompatibility-Tests in Europe, United States and Japan respectively as specified below. However, the biocompatibility tests were recorded on tests specimens of Ultraform PRO to show compatibility and potential suitability of the material in general. The biocompatibility-tests and the other tests listed below are not part of any continuous production control.

European Pharmacopoeia, Japanese Pharmacopoeia:
The composition of the product complies with the basic requirements of the European Pharmacopoeia 8th Edition, Chap.
3.2.2. "Plastic Containers and Closures for Pharmaceutical Use" and with the basic requirements of the Japanese Pharmacopoeia,16th Edition, General Information, “17. Plastic Containers for Pharmaceutical Products”. However, suitability for the end application concerned including observation of given limitations and toxicological thresholds have to be ensured on the final article by the producer.

US Pharmacopoeia: Biological Reactivity Tests, USP Plastic Class VI (USP VI)

ISO 10993-5: Biological Evaluation of Medical Devices Part 5: Test for Cytotoxicity

DMF: A Drug Master File (DMF) has been registered at FDA for Ultraform® PRO.

Food Contact: Ultraform® PRO is in compliance with multiple regional food contact regulations, especially for Europe and United States.

Additional compliances may also be available. Please contact your local representative or the Ultraplaste Infopoint (E-Mail: ultraplaste.infopoint@basf.com, Telefon: 49 621-60-78780, Fax: 49 621-60-78730).

For notice:
However, BASF has not designed or tested its plastics with respect to all of the special requirements related to their use in medical devices (defined in risk classes I to III according to the European and US Medical Device legislation) and pharmaceutical applications. Therefore BASF makes no warranties, express or implied, concerning the suitability of any BASF plastics for use in any medical device and pharmaceutical applications.

Abbreviated designation according to ISO 1043-1: POM
Designation according to ISO 29988-POM-K,,M-GNR,4-2

PREPROCESSING
Pre/Post-processing, max. allowed water content: .2 %
Pre/Post-processing, Pre-drying, Temperature: 100 °C
Pre/Post-processing, Pre-drying, Time: 3 h

PROCESSING
injection molding, Melt temperature, range: 190 - 230 °C
injection molding, Melt temperature, recommended: 200 °C
injection molding, Mold temperature, range: 60 - 120 °C
injection molding, Mold temperature, recommended: 90 °C
injection molding, Dwell time, thermoplastics: 10 min

Processing

Usual single-flighted three-section screws with an effective screw length of at least 15 D, better 20 - 23 D are suitable for the injection molding of Ultraform.

Pretreatment

Granules or pellets in original packaging can be processed without any special pretreatment. Granules or pellets which have become moist due to prolonged or incorrect storage (e.g. by formation of condensed water) must be dried in dehumidifying or recirculating air dryers for approx. 3 hours at about 100 - 110 °C. The moisture content should not exceed 0.2 %.


Postprocessing

If parts were produced at a comparatively low mold temperature (e.g. in order to obtain short cycle times) and must not change their geometry in use thermal postprocessing inducing dimensional changes by postcrystallization may be necessary. In such cases parts should be stored in an oven with recirculated air at temperatures of 100 - 130 °C until dimensions don't change significantly any further. The time needed for this has to be determined experimentally.