Integration of the entire production process in Cleanroom class 8 according to ISO 14644-1

Il processo produttivo dei tubi Dynamic Cleanroom-Platinum e Puralife si svolge interamente in cleanroom

23/05/2019

HOSES FOR THE PHARMACEUTICAL INDUSTRY:  DYNAMIC® CLEANROOM PLATINUM & PURALIFE

INTEGRATION OF THE ENTIRE PRODUCTION PROCESS IN CLEANROOM
CLASS 8 ACCORDING TO ISO 14644-1

 

 

Nowadays, the pharmaceutical industry is setting increasingly important challenges. In their daily business, they have to face the requirements  of excellence in manufacturing and the need of maintaining a high quality level in the production plants.  As a consequence, these evolutions also have an important impact on the suppliers of equipment and components for this market segment. In fact, one of the most critical aspect of this market evolution is to combine the expectations of the pharmaceutical companies about purity with the technical requirements of the hose manufacturers like MTG and the constraints arising from their manufacturing plants.

 

For this reason,  MTG has made important investments for the integration of the entire production process by using exclusively internal resources, from the production of semi-finished products to finished product, with the aim to keep constant quality level and avoid any potential source of external cross-contamination

 

Which MTG hoses are an example of this effort?

The hoses DYNAMIC® CLEANROOM PLATINUM (white PFA) and  PURALIFE (black PFA), developed for the pharmaceutical industry, truly reflect this production concept. In fact, both hoses are manufactured in a cleanroom class 8 according to ISO 14644-1, where the following stages of the production process take place:

    • Extrusion of the PFA tubing starting from the granules of raw material;
    • Etching of the tubing;
    • Platinum silicone calendering;
    • Hose production;
    • Packaging of the finished hose.

Traceability is ensured throughout the whole production process: from the production of the PFA tubing to the finished hose.

 

Main benefits and application

The hoses DYNAMIC® CLEANROOM PLATINUM and  PURALIFE are used for many applications in the pharmaceutical and biotechnology industry. In addition to the purity in the process, both products guarantee excellent heat and chemical resistance, impermeability, and flexibility. The entire hose structure is manufactured with ingredients and elements of USP class VI pharmaceutical grade and food quality, maintaining the quality of the product conveyed.

 

To learn more about these hoses please contact MTG Sales Office.

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