GEA Niro - PHARMASD
A standard GEA Niro PHARMASD™ plant include a certified venturi and calibrated differential pressure measurement...
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Documents & Manuals
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Features of PHARMASD
HEPA filters included for pharmaceutical production The standard GEA Niro PHARMASD™ spray dryers are based on components from our well-proven range of small-scale plants, but designed to fulfil the requirements for cGMP production, such as production of Active Pharmaceutical Ingredients (API). This means that the process gas and possibly atomization gas pass through a HEPA filter before getting in contact with the pharmaceutical product. Further, the exhaust gas is typically filtered through a bag filter and a police HEPA filter. Filter housings and duct work are designed so integrity testing of HEPA filters is straight forward.
The plants are operated with a slight positive pressure to protect the product quality. Only in production of very potent drugs will a plant design with negative pressure be applied.
Carefully selected materials with certificates All stainless steel surfaces coming in contact with the pharmaceutical product are made in AISI316 (EN 1.4401/1.4436) or better and come with material certificates. Gasket materials with product contact comply with FDA 21 CFR part 177.
Cleaning of a standard GEA Niro PHARMASD™ spray dryer A cleaning turbine can be placed in the drying chamber and the prepared bag filter housing to facilitate cleaning. In larger plants, WIP nozzles can also be placed in the product ducts. However, the QSD design will always call for manual cleaning and inspection.
General Specifications
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