Spray Drying for Pharma Applications
PHARMASD™ Spray Dryer
Whether it is to obtain increased bio-availability; controlled release or taste masking; or to produce precisely defined fine powders for inhalation or other applications, PHARMASD™ Spray Dryers allow you to unlock the potential of spray drying.
Whether it is to obtain increased bio-availability; controlled release or taste masking; or to produce precisely defined fine powders for inhalation or other applications, PHARMASD™ Spray Dryers allow you to unlock the potential of spray drying.
With experience gained from decades of serving the pharmaceutical industry, GEA has developed a well proven and robust range of PHARMASD™ Spray Dryers. Our PHARMASD™ range comprises a complete portfolio of GMP spray drying plants – ranging from the PSD-1 lab size units suitable for initial testing under GMP conditions and small productions – to the largest GMP production units for industrial purposes.
The PHARMASD™ Spray Dryers have been designed using standard modules that incorporate all the required features necessary for cGMP production. The philosophy is that standardized modules are built together to meet the requirement for a specific duty. All plants are designed and configured to meet individual User Requirement Specifications.
With no or only minor modifications to the process set-up and the controls software, a standard PHARMASD™ plant can cater for even advanced needs. A range of options, components and add-ons are available to meet unique demands whether it is in terms of product properties, control systems or cleaning. Especially in the case of large spray dryers, installations need to be adapted specifically to the site. We have a huge expertise in integrating up- and down-stream operations, Clean-In-Place (CIP) systems as well as process control systems integration. We work in close cooperation with our customers to design optimal solutions.
The PHARMASD™ Spray Dryers extends from a lab size unit suitable for testing under cGMP conditions as well as small productions up to large-scale production units with a nominal drying gas rate of 4,000 kg/hr.
The PHARMASD™ Spray Dryers are also available in a high-containment design allowing for safe spray drying of potent compounds at containment levels below 10 µg/m3 (OEL). The design provides for high personal protection and a safe working environment during operation, discharge and cleaning. This allows pharmaceutical companies to exploit the benefits of spray drying even of potent products requiring special precautions.
We work in close cooperation with our clients, performing detailed risk assessments and determining the optimal combination of spray dryer, isolator technology, Standard Operating Procedures (SOPs), etc. The concept is also suited for upgrading existing installations.
Designed for GMP production
All PHARMASD™ Spray Dryers are based on components from our well-proven GEA Spray Dryers and designed especially to fulfil the requirements for GMP production.
In the PHARMASD™ Spray Dryers both process and atomization gas passes through a HEPA filter before getting in contact with the pharmaceutical product. Exhaust gas is typically filtered through a bag filter and a police HEPA filter, and all 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. The 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.
Before leaving the workshops all components pass the Factory Acceptance Tests (FAT) as defined in connection with Design Qualification (DQ). The FAT documentation not only includes material certificates and instrument manufactures’ calibration certificates. Copies of welders’ certificates are included, welding seems are inspected, and surface finish measured – just to mention a few. And very important, all activities are carefully documented to fulfil pharmaceutical Qualify Assurance demands.
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.
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