Fedegari Group has engineered a set of products specially designed for clean room applications and aseptic manufacturing:
FMF – UNIDIRECTIONAL FLOW FAN FILTERS MODULES
FMF is a modular unit which creates a vertical unidirectional airflow in Class ISO 5 according to ISO 14644-1 (“Grade A” EU GMP), protecting the critical area. The airflow maintains the clean room under a higher pressure than the surrounding environment, thus avoiding any contamination risk.
FMF modules can be combined together to create a tailor-made solution to assure the most cost-effective protection to critical areas inside pharmaceutical production sites.
DESIGN & TECHNICAL FEATURES
AISI 304 stainless steel casing.
Suitable for different assembling solutions (suspended, fitted on false ceiling grids or on supporting legs).
G3/G4 efficiency disposable synthetic fibre pre-filters (according to EN 779) and H14 efficiency filters.
FCP – CAPPA DOWN CROSS
FCP – Down Flow Booth is a unidirectional vertical airflow unit, ISO 5 air cleanliness classification according to ISO 14644-1 (Grade A air supply and Class C according to EU GMP) designed to contain any kind of pharmaceutical powders or chemicals during sampling and dispensing operation. FCP has been designed according to the ISPE Good Practice Guide: “Assessing the Particulate Containment Performance of Pharmaceutical Equipment”.
The booth design adresses operation of sampling and dispensing and assures total protection of the operator, of the environment and of the product.