Clean Rooms

SIMA – MIHOV could manufacture various thermoplastic injection mouldings in a clean room environment Class 8 in accordance with ISO 14644 (or Grade D according to EU GMP). Specific premises and facilities are designed to be in compliance with the requirements for Class 8 (according to ISO 14644). The design has been approved by the Bulgarian Drug Agency. The premises are built and air-conditioned (via a clean-room HVAC system) in accordance with the requirements of GMP for production of medicinal drugs.

 

In general, in a clean room environment Class 8, our company could manufacture diverse injection moulded plastic products/components/parts for various application areas, especially in the fields of the pharmaceutical industry, the cosmetics industry, and the food and beverage industry. Our potential clean-room product range includes (but is not limited to):

•   primary packaging materials (e.g., for medicinal drugs, for cosmetic products, etc.)

•   medicinal products (medical devices);

•   laboratory products;

•   items in the area of the food and beverage industry with microbial count requirements.