MTG is pleased to announce the achievement of the certification Class 8 – In Operation – according to the norm ISO 14644-1 for the new Cleanroom production facility. Moreover, it has achieved an additional classification regarding the level of microbial presence (air and surfaces) as defined in Annex 1 of the GMP (Good Manufacturing Practices).
The Cleanroom has been created with the aim to preserve the high quality and purity of hoses for the pharmaceutical industry. MTG has been working in this industry for years and is well aware of the needs of pharmaceutical companies; for this reason, it is committed to continual improvement for the achievement of higher quality levels. In fact the increasing attention paid to the quality of products, the development and spread of increasingly stringent international regulations that place the focus on the purity of the pharmaceutical products and the risks associated with a possible contamination, force the operators of the pharmaceutical industry to research more safe and better performing products.
Key Features and Products
The Cleanroom develops in an area of 1000 sqm (approx. 11.000 sq ft) and it is part of the manufacturing facility of the MTG PHARMA DIVISION. The Cleanroom is dedicated to the production of semi-finished products (including the extrusion and etching of the perfluoropolymer tubing) and finished products such as:
- Platinum cured silicone hoses and hoses with perfluoropolymer liner and silicone cover (both in lengths up to 30 meters)
- Hoses for pharmaceutical powders and tubing
All products are manufactured with materials that meet the most stringent pharmaceutical standards.
Highly specialized staff is working in the Cleanroom. The operators are trained in compliance with the strict internal procedures developed to control production activities, storage of materials and cleaning by maintaining the right particle and microbiological levels in the whole environment.