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Labels in accordance with FDA 175.105 (US Food and Drug Administration)

The US Food and Drug Administration controls the safety and the effectivity of drugs for human and animal medicine, biological products, medical products, food as well as the devices emitting radiation. This applies to the products made in USA and to the imported products as well.

Medical products like auto injectors and all materials, which come into direct contact with a patient, must be evaluated biologically and examined for the biological compatibility. Here the interactions with tissue, cells and body liquids will be evaluated to exclude any potential biological risks.

Also the labels for pharmaceutical secondary packaging or blood bags must fulfil the regulations by FDA. Here harmful substances must not migrate into the product. For that reasons only labeling materials and adhesives will be used, which comply with the regulations in accordance with FDA 175.105.

The main features of labels in accordance with FDA 175.105

  • Labels for medical products and the labeling for the blood plasma bags with certified safety in regard to indirect additives, adhesives, and coating components for human and animal health
  • Subsequently inscribable with thermal transfer printing
  • Certified for the export to the USA
  • High abrasion resistance with suitable thermal transfer ribbons for the thermal transfer printing
  • Suitable for the labeling in compliance with standards
  • Very thin and soft and smooth materials available also for small application areas
  • Very high adhesive power of the labels even on tight radii like e.g. vial tubes or tubules
  • Process optimization due to automation of the material and product flow
  • Additional safety functions like e.g. holographs possible
  • A variety of special materials by Avery, 3M, Flexcon, and Tesa are available from stock
  • Plain labels in individual formats and special forms

Advantages of the labels in accordance with FDA 175.105 – precisely tailored to your requirements for the labeling

The labels made of pre-certified materials in accordance with FDA 175.105 offer product safety for the manufacturer as well as for the consumer. Moreover, for the manufacturer they offer protection against recourse claims. Additionally, there is a short-termed availability and realization time of projects, because numerous materials are available from stock.

In general, our labels in conformity with FDA offer the most possible flexibility and will be tailored individually to customer’s requirements. The labels can be delivered preprinted in variable amounts and inscribed with current data at the site, by that the storage and the management of numerous labels may be dropped or reduced significantly.

Our upscale and accurate processing with most modern die-cutting technologies guarantees the highest precision and reliability for the label application. Thus even labels with adhesives which are difficult to process can be processed mechanically very well, which increases the user efficiency in the long term.

Frequently Asked Questions

  • Labels on the secondary packaging of pharmaceutical products
  • Products of medical technology like e.g. auto injectors or devices for radio therapy
  • Marking and labeling of blood plasma bags
  • Temperature resistance from +140° C (284° F) to -196° C (-320.8° F)
  • Very thin (min. 6µ) combinations of foils are possible
  • High-performance materials made of acrylate-foil, polyimide foil, aluminum foil and polyester (PET)
  • Permanent/removable adhesives with a very good adhesive power for high- and low-energy substrates
  • Customized materials with e.g. colored adhesives are possible (pantone or RAL colors)
  • Diverse carrier materials like compressed kraft paper in different thicknesses, transparent plastic liner, kraft paper siliconized on both sides, and environmentally stable kraft paper available
  • Subsequently inscribable with thermal transfer printing
  • Foil features are from soft and smooth and stretchy to stable and tear-proof

As a manufacturer robos-labels has a wide range of already approved and certified labeling solutions. When additional customized licenses are required, we can take on the approval- and certification process if desired.

We already meet the following standards and regulations with our raw materials:

  • UL969 Marking and labeling systems (labels on smooth and not convex surfaces)
  • UL817 Safety cord sets and power supply cords
  • UL2238 Cable assemblies and fittings for industrial control and signal distribution
  • UL94 Flammability of plastic materials for parts in devices and appliances (UL VTM-0 strictest classification)
  • FMVSS 302 Evaluation of the flammability of interior materials (flammability/burn rate)
  • BS 5609 Label resistance to saline sea water
  • REACH, RoHS and IMDS conformity
  • ADR 2021 Ordinance on the transport of dangerous goods by road, rail and inland waterways (GGVSEB)
  • CLP Regulation (Classification, Labelling and Packaging, in accordance with EC No. 1272/2008)
  • DIN EN ISO 11683:1997-11 Packaging – Tactile warnings of danger – Requirements

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Customer service

Tel.: +49 (0) 7154 / 8225–90
Fax: +49 (0) 7154 / 8225–22

Customer service

Robos GmbH & Co.KG
Im Moldengraben 47
70806 Kornwestheim