PHARMA-SD® 制药级喷雾干燥机

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:

1. High containment plants for processing OEB levels 3-5 powders
2. Aseptic plants for sterile powder applications
3. User-friendly process control software configured the way you want for your plant and line 
4. Dedicated GEA test facilities and access to expert advice and analytics 
   
    

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.