Features of Pilotech Pharmaceutical Spray Dryer
- ±1 ℃ PID control for strict protection of heat-sensitive APIs
- 10 mL micro-batches to help save your high-value materials
- Electropolished 316L meets cGMP/FDA contact standards
- 21 CFR Part 11 audit trail ensures untampered data integrity
- Wide selection of wetted part materials
Your Trusted Pharmaceutical Spray Dryer Manufacturer
The pharmaceutical spray dryer converts liquid formulations, suspensions, or emulsions into dry powders through atomization and rapid heat and mass transfer. It is suitable for formulation development, process optimization, and scale-up from laboratory to pilot scale for APIs, pharmaceutical formulations, and heat-sensitive drugs.
Pilotech has been manufacturing and developing lab spray dryers since 2005, with 21 years of experience in spray drying technology. Our production lines are equipped with stamping, cutting, and polishing equipment to support in-house manufacturing and equipment development. We offer laboratory and pilot-scale pharmaceutical spray dryers in open-loop, closed-loop, and other configurations for different process requirements. For specific materials or process conditions, our team can develop customized spray drying systems. Beyond pharmaceutical applications, we provide customized equipment solutions for materials, food, biotechnology, chemicals, new energy, ceramics, and other industries.
Compact design with minimal hold-up volume. Processes small sample batches using high-precision control. Suitable for early R&D formulation screening, academic research, and saving expensive active pharmaceutical ingredients.
Higher feed capacity for process development and scale-up studies, helping verify drying conditions and powder properties before production. Good choice for pharmaceutical formulations, API processing, and pilot batches.
Uses continuous fresh air to evaporate water-based feeds and the exhaust gas discharged after drying. Offering a simple and cost-effective setup. Suitable for aqueous pharmaceutical formulations, non-flammable feeds, and routine formulation development.
Recirculates nitrogen or other inert drying gas while recovering solvent vapors, reducing oxygen exposure and solvent emissions. Provides maximum safety against explosions. Mandatory for handling organic solvents, volatile formulations, and oxygen-sensitive pharmaceutical compounds.
Uses the powerful shear force of compressed gas to atomize liquid material into fine droplets, providing micron-sized particles. Well suited to laboratory development, inhalation powders, APIs, and low-viscosity formulations.
Forces the feed liquid through a small orifice under high pressure, producing droplets with extremely uniform size without atomizing gas. Suitable for larger feed rates, scale-up studies, and low-viscosity, low-solids slurry.
Uses centrifugal force produced by a high-speed rotary disc to fling liquid into droplets. Provides dense, free-flowing powders. Designed for high-throughput pilot processing, sticky feeds, and large-diameter drying chambers.
Pharmaceutical Spray Dryer Specifications
The parameters in the table below cover various pharmaceutical spray dryer models. Specifications vary by model and configuration.
| Specification | Typical Range / Configuration |
| Equipment Scale | Laboratory / Pilot Scale |
| Feed Capacity | 0.5–10 L/h |
| Minimum Sample Volume | 10–200 mL |
| Feed Type | Solutions / Suspensions / Emulsions |
| Feed Pump | Peristaltic Pump |
| Inlet Temperature | 60–300°C |
| Outlet Temperature | 40–160°C |
| Temperature Accuracy | ±1–2°C |
| Rated Airflow | 0.5–4 m³/min |
| Atomization Method | Two-Fluid Nozzle |
| Optional Atomization | Three-Fluid Nozzle / Other Configurations |
| Nozzle Diameter | 0.5–2.0 mm |
| Atomization Gas | Compressed Air / Nitrogen |
| Atomization Pressure | Approx. 0.2–2 bar |
| Particle Size | Approx. 1–120 μm |
| Residence Time | Approx. 1–3 s |
| Drying Gas | Air / Nitrogen |
| Operating Mode | Open-Loop / Closed-Loop |
| Solvent Compatibility | Aqueous / Organic Solvents |
| Inert Gas Circulation | Optional / Available |
| Solvent Recovery | Optional |
| Oxygen Concentration Control | Available for Inert-Loop Systems |
| Powder Separation | Cyclone Separator |
| Powder Collection | Collection Vessel / Receiving Tank |
| Temperature Control | PLC Automatic Control |
| User Interface | Touchscreen |
| Contact Materials | SUS316L / Borosilicate Glass |
| Low-Temperature Processing | Available with Low-Temperature / Vacuum Configurations |
| Power Supply | 220 V Single Phase / 380 V Three Phase |
| Typical Applications | API / Pharmaceutical Formulations / Biologics / Dry Powder Development / Process Scale-Up |
Materials Used in Pharmaceutical Spray Dryers
SUS304
304 stainless steel offers good mechanical strength and basic corrosion resistance, and is relatively inexpensive.
However, it has poor resistance to chloride pitting and strong acids and alkalis, making it unsuitable for direct contact with saline, acidic APIs, or solvents. Therefore, it is not recommended to choose equipment with 304 stainless steel wetted parts. But this material is a cost-effective choice for general-purpose auxiliary components in laboratories.
SUS316/316L
Compared to 304 stainless steel, 316 stainless steel contains additional molybdenum and has extra-low carbon content. It offers excellent resistance to pitting and intergranular corrosion and meets GMP and FDA compliance requirements for API-contacting surfaces. This material supports repeated high-temperature steam sterilization (SIP) and clean-in-place (CIP) processes.
Pilotech uses 316 stainless steel for the wetted parts of most spray dryers, although it has higher procurement and processing costs. While 316 stainless steel can corrode when exposed to substances like highly concentrated hydrochloric acid, it suits most feed liquids.
Borosilicate Glass
Borosilicate glass exhibits extremely high chemical inertness and corrosion resistance, allowing it to safely come into contact with the vast majority of organic solvents, acids, and bases without the risk of metal ion contamination. Furthermore, the glass is fully transparent, making it ideal for visually monitoring the entire drying process.
However, borosilicate glass is fragile, unsuitable for high-pressure environments, and has a lower thermal conductivity than metal, making it impossible to manufacture drying towers of excessive volume. Pilotech offers laboratory pharmaceutical spray dryers with borosilicate glass wetted parts. Full transparency allows real-time visual monitoring of droplet atomization, wall deposition, and drying behavior. They are suitable for educational and other applications.
Two-Fluid Nozzle vs Pressure Nozzle vs Rotary Atomizer for Pharmaceutical Spray Drying
Two-fluid nozzles are the most widely used in laboratory and pilot-scale pharmaceutical spray dryers. Pressure nozzles are primarily used in special pilot-scale applications that require larger droplets, and rotary atomizers are also mainly used in pilot-scale equipment.
| Feature | Two-Fluid Nozzle | Pressure Nozzle | Rotary Atomizer |
| Working Principle | Uses high-speed shearing force from compressed air or nitrogen to break liquid into micro-droplets. | Relies on a high-pressure pump to force liquid through a micro-orifice, converting pressure energy into kinetic energy for atomization. | Uses centrifugal force from a high-speed rotating disc (usually 20,000–50,000 RPM) to fling and atomize liquid. |
| Particle Size and Particle Size Distribution | Can achieve an extremely fine rating (typically 2–30 µm), narrow distribution. | Coarser (typically 50 – 300 µm), broader distribution. | Medium to coarse (typically 20 – 150 µm), relatively uniform distribution. |
| Scale and Capacity | Very small to medium (10 mL/h – 10 L/h); top choice for lab and pilot R&D. | Requires higher minimum flow rate (typically more than 5 – 10 L/h); unsuitable for micro-scale lab trials. | Medium to high flow rate (typically more than 2 – 5 L/h); better suited for pilot scale and industrial scale-up. |
| Spray Pattern | Narrow conical spray, ideal for narrow lab-scale drying towers. | Narrow to medium conical spray, moderate requirement for drying chamber diameter. | 360° horizontal radial spray, requires a wide-diameter drying chamber. |
| Feed and Viscosity Tolerance | Excellent tolerance for high viscosity and high solid content. Rarely clogs. | Sensitive to high viscosity. Suspended particles easily clog micro-orifices or cause abrasive wear. | Outstanding tolerance. Handles high-viscosity, high-concentration feeds and slurries with large particles. |
| Parameter Control | Dual independent control (Liquid/Gas). Feed rate and gas-to-liquid ratio(GLR) can be adjusted separately. | Highly coupled. Pressure dictates both flow rate and droplet size simultaneously. Limited flexibility. | Decoupled speed and feed. Droplet size is independently controlled by adjusting disc speed. Highly flexible. |
| Particle Morphology and Density | Tends to form fine, low bulk density, porous, or hollow spherical particles. | Larger particle size, moderate particle density. | Produces denser, solid particles with high bulk density and excellent powder flowability. |
| Min. Sample Volume | Ultra-low (10 – 20 mL), saves valuable and costly APIs. | Higher (requires filling high-pressure lines and pump body, typically several hundred milliliters). | Higher (limited by hold-up volume in feed lines and atomizer disc, typically more than 200 – 500 mL). |
| Cleaning and Maintenance | No high-speed moving parts, simple structure, extremely easy to disassemble and autoclave. | Requires maintenance of high-pressure pumps and seals. Nozzle orifice is subject to wear. Cleaning is simple. | Contains high-speed motor and bearings. Complex structure with higher cleaning validation difficulty. |
Spray Dryer in Pharmaceutical Industry: Applications and Benefits
Dry Powder Inhalers (DPI)
Pulmonary drug delivery has extremely strict requirements on aerodynamic particle size, which must typically be within the range of 1–5 µm. Conventional milling can lead to structure destruction, electrostatic agglomeration, and an extremely broad particle size distribution. The two-fluid nozzle spray drying process can directly produce low-density, micron-sized spherical particles with a narrow size distribution and high geometric symmetry. This significantly improves the fine particle fraction (FPF).
Amorphous Solid Dispersions (ASDs)
Poorly soluble APIs have extremely low solubility in water, and the high temperatures involved in traditional hot melt extrusion (HME) can easily lead to drug degradation. Wet crystallization tends to cause recrystallization of the API.
In contrast, the evaporation process in spray drying is extremely rapid, allowing the API and excipient to be fixed in an amorphous state the instant the droplets dry, effectively preventing the drug molecules from crystallizing. This can significantly improve drug solubility and dissolution rate.
Proteins, Peptides and Vaccines
Spray drying can convert insulin, monoclonal antibodies, vaccines, or enzyme preparations into dry powders for long-term stable storage or as dehydrated formulations. Traditional freeze-drying often takes several days or even one week. It is extremely time-consuming and energy-intensive. Furthermore, the freeze-thaw cycle can easily lead to protein denaturation.
Although the inlet temperature in spray drying is relatively high, the rapid evaporation of the solvent removes the majority of the heat. Furthermore, by selecting a co-current spray dryer or a vacuum low-temperature spray dryer, the wet-bulb temperature of the material can be kept low (even below 40–50°C). Since the heating time is only a few seconds, biological activity is preserved, and production efficiency is significantly higher than that of freeze-drying.
How to Choose Pharmaceutical Spray Dryer Capacity?
If you are in the laboratory or pilot-scale phase, the key to selecting pharmaceutical spray dryer capacity is not to pursue the highest throughput, but rather to align material costs, the R&D stage, and the minimum sample volume.
Early R&D and Formulation Screening
At this stage, minimizing raw material waste is most important. We recommend selecting a benchtop or lab spray dryer with a water evaporation rate of 1.0–1.5 L/h.
Since API or other raw materials supply is limited at the early stage, you should primarily consider the equipment’s recovery rate and minimum feed volume. For example, whether it supports micro-scale testing of 10–20 mL. It is best to select equipment with a compact drying tower, minimal dead space, and high micro-scale recovery rates. These designs will help you minimize material waste.
Process Optimization and Pre-Clinical Trials
At this stage, you will need to investigate how parameters including airflow rate, inlet temperature, and pump speed affect particle characteristics. Therefore, the equipment must offer a higher degree of control precision. If your feed liquids include organic solvents or highly oxidizable contents, a closed-loop system is also required.
We recommend selecting high-specification laboratory or small-scale pilot-scale spray dryers with a moisture evaporation capacity of 1.5–3.0 L/h.
Pilot Scale and Clinical Batch Production
For pilot scale and clinical batch production, we recommend selecting a pharmaceutical spray dryer with a water evaporation rate of 5.0–10.0 L/h. Pay special attention to scalability. The equipment must feature fluid dynamics and thermodynamic models consistent with those used at the industrial production scale. It must also include a GMP-compliant system, including 21 CFR Part 11 data acquisition, CIP interfaces, and containment protection.
Factors Affecting Pharmaceutical Spray Dryer Cost
Inert Gas Loop and Solvent Recovery System
Many pharmaceutical spray dryers need to process feed solutions containing organic solvents, so they require additional closed-loop systems. These systems include a condenser, an oxygen transmitter, an explosion-proof design, and more. The cost is typically 50%–100% higher than that of standard open-loop equipment.
Automation and Data Integrity
A standard spray dryer is equipped only with a basic control panel for adjusting parameters. In contrast, a high-end pharmaceutical spray dryer complies with strict international standards like 21 CFR Part 11 and features electronic signatures, multi-level user permissions, audit trails, and data tamper-proofing capabilities. This guarantees that all production data is authentic and traceable, prevents fraud, and comes at a higher cost.
Materials and Surface Treatment
As mentioned earlier, the price varies depending on the material used for wetted parts. In addition, for certain special materials, the internal surface finish may need to be upgraded from standard polishing (Ra < 0.8 µm) to pharmaceutical-grade electropolishing (Ra < 0.4 µm). This also increases processing costs.
Validation
Pharmaceutical spray dryers must demonstrate compliance with safety standards. Our documentation package includes comprehensive validation documentation (DQ/IQ/OQ/PQ) covering design, installation, operation, and performance, as well as factory testing and material safety certificates. The more comprehensive these testing and compliance services are, the higher the overall procurement cost of the equipment.
In a closed-loop pharmaceutical spray dryer, high-purity nitrogen is the most commonly used inert gas for handling organic solvents. The closed-loop system can reduce the oxygen concentration to below the safety threshold (typically <2%) to prevent explosions. For specialized pharmaceuticals that are highly prone to oxidative degradation, you can also consider carbon dioxide or argon as alternatives. However, you will need to evaluate their solubility in the solvent and their cost.
Friction between particles and polar solvents during high-speed atomization and within cyclone separators can easily generate static electricity, causing powder to adhere to the walls or posing a risk of electrical discharge. In our laboratory and pilot-scale spray drying equipment, we primarily neutralize charges by equipotential grounding, using conductive materials such as 316L stainless steel, and installing anti-static ionizing bars in the powder collection vessel. For drying gases, you can accelerate static discharge by appropriately controlling the humidity of the inlet air.
This depends on the material properties and production objectives. Freeze drying suits highly heat-sensitive injectables that must be preserved in their original vials. However, it requires a very long processing time, consumes significant energy, and requires subsequent grinding. Spray drying can directly convert liquid materials into dry powders with high sphericity and controllable particle size within seconds. It is particularly suited for improving the bioavailability of poorly soluble drugs or for preparing inhalation formulations, offering higher production efficiency and greater cost-effectiveness.
Both our laboratory and pilot-scale spray dryers feature a highly integrated design, making maintenance not complicated. Routine maintenance focuses on cleaning and preventing clogging of the two-fluid nozzle, regularly replacing O-rings, and monitoring the condition of the blower and HEPA filter. Since materials are frequently changed during the R&D phase, you can opt for equipment featuring a quick-release mechanism and modular components. This can significantly reduce maintenance time between batches, improving your efficiency.
To meet process analytical technology (PAT) and GMP data integrity requirements, the equipment can integrate a variety of online sensors. Common examples include in-line optical particle size analyzers (PSD) for monitoring particle size distribution, oxygen analyzers for measuring residual oxygen levels in pipelines, sensors for real-time temperature and humidity monitoring, and near-infrared (NIR) spectrometers or Raman probes for monitoring moisture content during the manufacturing process. These sensors help you achieve real-time quality control throughout the R&D process.
This depends on the equipment’s specifications and application. Benchtop laboratory equipment typically uses high-borosilicate glass or quick-release metal components. This design achieves easy disassembly and facilitates thorough cleaning and sterilization during the R&D phase. In contrast, pilot-scale equipment, due to the increased size and weight of its components, more frequently employs Clean-in-Place (CIP) and Sterilize-in-Place (SIP) designs. Through the use of built-in sanitary rotating spray balls and piping with no dead zones, these systems meet GMP-level cleaning validation requirements without the need for manual disassembly.