GMP Spray Dryer

Calibrated instrumentation for development work
As soon as initial feasibility tests have shown that spray drying can be an important process step for a pharmaceutical product, it is of vital importance that the process conditions are accurate and documented. GEA Niro’s line of small-scale spray dryers is great for the initial work, but their instrumentation is basic. To fulfil the requirements of the pharmaceutical industry, the instrumentation is expanded and upgraded for GMP Spray Dryers (QSD line).

All QSD plants include a certified venturi and calibrated differential pressure measurement to monitor the process gas flow and automatic control of the supply fan. All instruments critical for  product qualities are delivered with manufactures’ calibration certificates and can be re-calibrated according to Customer’s SOP.

HEPA filters included for pharmaceutical production 
QSD spray dryers are based on components from GEA Niro’s well-proven range of small-scale plants, but QSD plants are designed to fulfil the requirements for GMP 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.

QSD 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 QSD spray dryer
A cleaning turbine can be placed in the drying chamber and the prepared bag filter housing to facilitate cleaning. In larger QSD plants, WIP nozzles can also be placed in the product ducts. However, the QSD design will always call for manual cleaning and inspection. If your product or production requires automatic cleaning on a very high level, please refer to the specialized PSD line.