Spray Drying for Pharma Applications
PHARMA-SD® Spray Dryer
The comprehensive family of GEA NIRO PHARMA-SD® spray dryers offers the pharmaceutical, biotech, and associated contract manufacturing sectors a versatile, fully scalable line of GMP spray dryers for processing both small molecule pharmaceuticals and biologics.
Customized solutions for specific requirements
The PHARMA-SD® 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 PHARMA-SD® 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 PHARMA-SD® 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.
Spray drying of potent compounds
The PHARMA-SD® 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.
Design details
Designed for GMP production. All PHARMA-SD® spray dryers are based on components from our well-proven GEA spray dryers and designed especially to fulfil the requirements for GMP production.Design features
In the PHARMA-SD® 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.
Carefully selected materials with certificates
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.
Pharmaceutical spray drying at every scale
Backed by decades of GEA experience serving the global pharmaceutical industry, we’ve developed a portfolio of GEA NIRO PHARMA-SD® (PSD) spray dryers, ranging from R&D units for early testing or small-scale production under GMP conditions, up to high-volume GMP production plants for manufacturing at the largest industrial scale. For large-scale installations GEA offers broad expertise in integrating upstream and downstream operations, cleaning systems, and process control system integration.
We’ve listened to our customers worldwide and developed spray drying plants designed to give you ultimate confidence and control when processing even the most challenging of pharmaceutical powders. We deliver what you need:
- High containment plants for processing OEB levels 3-5 powders
- Aseptic plants for sterile powder applications
- User-friendly process control software configured the way you want for your plant and line
- Dedicated GEA test facilities and access to expert advice and analytics
Aseptic and high-containment spray drying plants
GEA expertise covers the most demanding pharmaceutical powder applications. In addition to our standardized and customizable GEA PSD systems, the GEA ASEPTIC-SD® spray drying plant has been developed to give you confidence in safe, reliable sterile powder manufacturing. We also have global expertise configuring high containment spray drying plants for processing up to the highest potency level (occupational exposure band (OEB) level 5).
Dedicated pharma spray drying test center
GEA doesn’t just sell equipment. Experts at our European test center for spray drying can work with you to evaluate, optimize and scale up your processes and equipment. At the GEA test center you can configure and test GEA PSD plants, tap into specialist expertise and troubleshoot. You can also work with us to analyze pharmaceutical powder characteristics and properties and integrate upstream and downstream processes.
Seamless scalability and compatibility
The GEA PSD series of spray dryers is scalable and fully compatible across the product line, so in-house process development from laboratory scale to commercial production is as seamless and efficient as possible, reducing re-validation efforts and potentially time to market and. Full compatibility across the range also makes it relatively fast to transfer pharmaceutical spray drying technology from collaborators or CMOs already using GEA PSD plants.
Customized pharma spray drying solutions
The GEA PSD series of spray dryers is designed for cGMP production and can be tailored to meet individual user requirement specifications (URS). Highly adaptable, the PSD plants can commonly be customized to meet advanced production needs with minimal or no modifications to the process setup and control software.
A range of options, components, and add-ons are available to address unique product properties or cleaning requirements.
- We’ve developed a sanitary wettable bag filter fitted with special nozzles that wet all internal product contact surfaces before opening, to ensure that no powder becomes airborne when accessing the plant, for example, for cleaning. The wettable bag filter can be an ideal additional safety option when spray drying highly potent active pharmaceutical ingredients (HPAPI).
- The latest GEA Cyclone Extra Efficiency (CEE) cyclones provide high powder separation efficiency, even for the smallest particles, which can give you improved powder yield, while also reducing the risk of powder smearing inside the cyclone.
- For larger spray drying plants we can configure heat recovery technology that may significantly reduce overall energy requirements and cut fossil fuel use, to improve your carbon footprint.
- Why not ask about our patented spray dryer nozzles that let you process the finest pharmaceutical powders for administration by inhalation?
Aseptic spray drying
GEA ASEPTIC-SD® plants are designed to achieve the highest standards of product sterility. These systems are built with fully contained process flows, sterilizable components, and integrated cleaning systems, making them ideal for parenteral applications, such as vaccines, biologics, and other injectable drugs.
Spray drying potent compounds
GEA PSD plants are also available in high-containment configurations, so you can safely spray dry high potency active pharmaceutical ingredients at containment levels below 1 µg/m³ (occupational exposure limit; OEL). Whether you are designing a new high containment spray drying plant from scratch, or are looking to upgrade an existing standard plant, our technical solutions offer high levels of personal protection and a safe working environment during operation, discharge, and cleaning.
Whatever your applications and existing setup we’ll work closely with you to carry out detailed risk assessments and determine the optimal combination of spray dryer, isolator technology, and standard operating procedures (SOPs).Design features for compliance and quality assurance
Our portfolio of dedicated PSD plants is designed for safe, cGMP-compliant production. Process and atomization gas pass through HEPA filters before contacting the pharmaceutical product, while exhaust gas is filtered through bag filters and police HEPA filters. The plants operate under slight positive pressure to protect product quality, while a negative pressure design is available for very potent drugs.
GEA’s PSD spray dryers are in addition equipped with certified venturi flow meters, calibrated differential pressure measurements, and automatic fan control. All critical instruments are delivered with manufacturers’ calibration certificates and can be re-calibrated according to customer SOPs.Certified materials and documentation
All GEA PSD components undergo factory acceptance testing (FAT) in accordance with Design Qualification (DQ) before delivery to our customers. The comprehensive FAT documentation includes material certificates, welders’ certifications, surface finish measurements, and calibration certificates. Product contact surfaces are made from AISI316 (EN 1.4401/1.4436) stainless steel or higher-grade materials, with gaskets that comply with FDA 21 CFR part 177.
Optimizing your GEA PSD plant performance
We aim to support great process and equipment performance throughout the lifecycle of your GEA PSD plant. We can let you know about potential upgrades and opportunities for optimization as we continue to develop our technologies, and we also offer a range of configurable service and maintenance packages, to help keep your pharmaceutical spray dryer performing optimally. Why not ask about our GEA Health Check Spray Dryer service, through which we’ll carry out a thorough plant inspection and provide a report with recommended maintenance actions that could help you better maintain the uptime, longevity and efficiency of your GEA PSD equipment.
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