Clean room for the pharmaceutical industry

Spetec GmbH has now extended its cleanroom offering to encompass three different cleanroom concepts. This means that it is possible to implement solutions for the whole range of requirements, from inexpensive installations right up to top-class cleanrooms compliant with the GMP guidelines for the pharmaceuticals industry. The cell itself is enclosed by an odorless plastic strip curtain or side panels made from acrylic or laminated glass or aluminum sandwich panels, resulting in a self-contained unit. The effective cleanroom area can be varied by combining individual laminar flow modules of different sizes. The SPETEC® cleanroom cell uses H14 filters with a cleanroom classification of 100. These have a filtration efficiency of 99.995 %. This means that the filter captures at least 99.995 % of all particles of a size of 0.12 μm (as per MPPS). The filtration efficiency is approx. 99.9995 % for particles with a size of 0.3 μm. This laminar airflow below the flow modules means that there is no crossover with dirty air from the outside. Using a SPETEC® cleanroom cell can, for example, reduce the particle concentration from approx. 15 million/m3 (at a size of 0.12 μm, MPPS) to approx. 1,500 particles within the unit. This corresponds to the cleanroom class 5 as per DIN ISO 5 or class 100 as per US Federal Standard 209E. It is also possible to meet the requirements of ISO classes 6 through 9 (DIN ISO 14644-1) and clas-ses A through D of the GMP standard. This means that, depending on the precise requirements, SPETEC® cleanroom cells can be custom built and adapted to meet the customer's needs