USP Class VI and Biocompatibility of Products for Pharmaceutical Use

08/09/2020

In our daily routine, sometimes we do not take into consideration the important work of designing and testing that is at the origin of every product intended for pharmaceutical use. This includes the production process, which should be carried out in compliance with safety requirements. In fact, the hoses for the pharmaceutical industry are intended for manufacturing products for human contact or for human use, and thus have to meet all the requirements of biocompatibility.

 

What Is Biocompatibility?

 

A material is biocompatible when it does not produce any harmful effect on vital functions, any allergic reactions, or other pathologies. Biocompatibility is historically referring to the USP class VI (United States Pharmacopoeia) for testing, where class VI represents the highest class.

 

USP Class VI Tests

 

In particular, regarding the USP class VI certification process, materials have to pass the biological tests, i.e. In vivo testing, USP <88>. Tests are based on material extracts that, according to the thermal resistance of the materials, are made after contacts and at one of the following temperatures 50 °C, 70 °C and 121°C (122 °F, 158 °F, and 250 °F). However, the evaluation process of biocompatibility of materials begins with the USP <87> in Vitro Testing, where tests are carried out on specific cell cultures.

 

Biocompatibility in The Manufacturing Process

 

The characteristics of biocompatibility of a product is part of a wider process of risk assessment, where the repeatability of the degree of purity of the materials has to be maintained in all phases of the hose manufacturing process. For this reason, the hose production environment has to be free from contaminants, such as additives or other potentially toxic residues deriving from material processing and storage, and from substances that can somehow alter the properties of the material both in the mass and in the surface.

 

USP Class VI in the MTG Production Process

 

MTG is aware that the first potential source of accidental pollution could be the production process of the hose, and it is aware of the implications arising from such risk. For this reason, all the hoses produced by MTG for the pharmaceutical and biopharmaceutical industry are produced in a cleanroom manufacturing facility integrating all production stages starting from the processing of raw material.

 

More Information About The MTG Cleanroom

 

The MTG cleanroom is certified according to ISO 14644-1 by a third-party organization and it is where the entire production process takes place, including the extrusion and surface treatment of the fluoropolymer tubing, the production of silicone semi-finished products, the production the hose, and its packaging. The aim is maintaining the integrity and safety of materials in all working phases.

 

 

To receive detailed information on the biocompatibility tests performed on the products, please contact the MTG staff at the following address: info@mtgspa.com

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