Misterium: a new concept in cleanrooms

28/05/2009

Misterium cleanrooms are designed for mixing sterile preparations and are configured to the client’s needs while requiring no construction projects to establish an area compliant with determined specifications for environmental contamination.

Grifols Engineering offers a solution which is suitable for industry, hospitals, pharmacies and research activities requiring small clean or sterile room areas in terms of particles or microorganisms.

Misterium can easily be adapted to a large variety of needs. Thanks to its modular system it can be tailored to the needs of the user and installed nearly anywhere without costly construction projects, increases in budget or delays in delivery thanks to its easy set-up modular system. In just 45 days after drafting the plans, Misterium is ready to be up and running once it has been officially certified. These units have walls and a roof which are 60mm thick, include a HEPA filter for air treatment and can be installed in an existing facility without disrupting its day to day activities. These rooms are suitable for activities involving the handling of cell cultures, for sterile filling and other preparations which require clean environmental conditions.

The room, its materials and accessories are all designed for sterile cleaning. In Misterium cleanrooms, the air is treated and pressure controlled, offering characteristics which are adequate for the preparation of cytostatics and biohazardous products. These rooms comply with classifications for either B, C or D classifications and UNE-EN12128 containment levels for microbiology laboratories.

Grifols Engineering forms part of Grifols group of companies and is specialized in biopharmaceutical engineering. GE also offers tailor-made designs and will adapt Misterium cleanrooms to comply with the client’s specific needs for application in various sectors. Currently, more than 90 Misterium cleanrooms have been validated and are functioning in both the industrial sector and hospitals in Spain, Portugal, Mexico, United States and Italy.