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Pharmaceuticals

Pharmaceutical Process Technology and Hygienic Powder Control

End-to-end solutions connecting thin film evaporation, wet granulation, and drug pelleting with GMP-compliant source capture and pharmaceutical dust containment. Protecting people and product from first particle to final dose.

The Challenge

Combined Pressure on Modern Pharmaceutical Manufacturing

Pharmaceutical manufacturers must simultaneously deliver consistent product quality, protect operators from API exposure, and satisfy increasingly stringent GMP and regulatory requirements across the entire process chain.

Process & Product Quality

Consistency under demanding conditions

Thermally sensitive products, solvents, potent APIs, and fine powders require tightly controlled processing. Inconsistent concentration, drying, or particle formation directly affect downstream handling, containment, and dosage performance.

Safety & Containment

Protecting operators and product integrity

Dispensing, transfer, and powder-handling steps expose operators to active pharmaceutical ingredients. Inadequate source capture increases exposure risk, cross-contamination potential, and cleaning burden across the facility.

Regulatory & GMP Compliance

Meeting OEL limits and hygiene standards

Stricter GMP expectations, occupational exposure limits, and cleaning validation requirements demand equipment designed for containment, documentation, and predictable performance across multi-decade production assets.

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Two Brands. One Concept.

From process to powder.
From granule to clean air.

Every pharmaceutical process combines two critical dimensions: how the product is formed, and how powders are handled once they exist.

API concentration and solvent distillation

Drying, granulation, and drug pelleting

Raw material dispensing and powder feeding

Hygienic dust capture and powder recovery

Speak with an expert

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Nederman MikroPul

Pharmaceutical Dust Collection & Hygienic Powder Containment

Definition

Pharmaceutical dust collection is the engineered source capture and containment of airborne API particles at powder-release points including dispensing, charging, transfer, and discharge from dryers and granulators. Unlike industrial dust collection, pharmaceutical systems must satisfy GMP hygienic construction standards, cleaning validation requirements, operator OEL protection, and cross-contamination prevention across multi-product facilities.

Hygienic construction — smooth surfaces for GMP cleaning validation
Smooth internal geometries minimize powder hold-up and residue build-up
Source capture at dispensing, charging, transfer, and dryer discharge points
OEL-matched containment for standard APIs and highly potent compounds
Explosion-protection integration for combustible or flammable powders
Shorter batch changeovers through simplified, validated cleaning design

API Dispensing & Charging Granulator Discharge Dryer Exhaust Capture Transfer Points HPAPI Containment

GMP Dust Control — Core Requirements

OEL-Based Containment Design

Containment performance matched to the occupational exposure limit of each active ingredient handled

Cleaning Validation Support

Smooth surfaces and fully accessible geometry for validated GMP cleaning procedures

Cross-Contamination Prevention

Dedicated containment boundaries prevent API migration between batches and products

Valuable Product Recovery

Captured API powder returned to process — reducing waste from expensive active materials

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Nederman MikroPul Pulse Jet Dust Collectors

Pulse jet baghouse dust collectors are used when it is impractical to shut down your dust collector to clean the bags. A pulse of compressed air is blasted through the bags to blow loose the built up particles on the bags to maintain optimum filtration efficiency.

HPC Dust Collector

MikroPul specializes in the design and production of solutions to meet ASME BVLC Section VIII, Division 1, Pressure Equipment Directive (PED) 2014/68/EU and DIN EN 14460. Solutions can be up to 25ft. (7.5m.) diameter, up to 725 psig (5.0 MPa) and 600C

Service and Parts

Nederman MikroPul has all the tools keep your system running at peak performance and compliant with the latest regulations. Knowledgeable and experienced people to help you.

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LCI Corporation

Extrusion-Spheronization & Drug Pelleting

Definition

Extrusion-spheronization is a pharmaceutical pelletization process that converts wet-granulated API-excipient masses into uniform, spherical pellets with narrow particle-size distributions (typically 0.5–2.0 mm). The process combines extrusion through a precision die plate with spheronization on a rotating friction plate, producing pellets with high API loading, excellent flowability, and consistent mechanical strength — ideal for controlled-release, modified-release, and multiparticulate dosage forms.

High active-content pellets — API loading above 90% achievable
Narrow particle-size distributions for uniform functional film coating
Excellent pellet flowability and mechanical strength
Supports controlled-release and modified-release dosage forms
Reduced variability during transfer, charging, and capsule filling
Reliable linear scale-up from development to commercial scale

Extrusion-Spheronization Sequence

Wet Granulation

API + excipients + granulating liquid

Extrusion

Through precision die plate → cylindrical extrudate

Spheronization

Rotating friction plate → sphere formation

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Spherical Pellets

0.5–2.0 mm, narrow size distribution, high flowability

Controlled-Release Capsules Modified-Release Pellets Multiparticulate Systems Capsule-Fill Applications High-Potency APIs

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Download the Brochure

Ensuring safe pharmaceutical production by protecting people and manufacturing processes with LCI Corporation and Nederman MikroPul

From Evaporation and Particle Formation to Safe Dust Capture and Containment

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LCI Corporation

Wet Granulation & Precision Powder Feeding

Definition

Wet granulation is a particle-size enlargement process that converts fine pharmaceutical powders into free-flowing granules by agglomerating primary particles with a granulating liquid under controlled shear conditions. The resulting granules exhibit improved density, compressibility, and API content uniformity compared to raw powders — directly reducing tablet weight variation and simplifying downstream powder handling and containment.

Predictable granule density and particle size for tablet compression
Improved API content uniformity across the entire batch
Significantly reduced dust generation — simplifies downstream containment

Powder Feeding & Dosing Capabilities

Accurate, low-rate powder feeding for continuous pharmaceutical manufacturing
Controlled dosing of difficult, cohesive, or poorly flowing API materials
Improved mass-flow stability prior to compaction or tablet compression

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Variability

Reduced batch-to-batch weight variation in tablet compression

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Uniformity

Improved API content uniformity across compaction

↓

Dust Load

Lower airborne API dust — simplifies containment requirements

✓

PAT Ready

Compatible with inline process analytical technology

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Predictable granules and pellets improve downstream flow, containment, and exposure control. Effective source capture then protects people, preserves product, and supports hygienic operation — forming the foundation for safer, more repeatable pharmaceutical manufacturing.

Speak with an expert

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LCI Corporation

Thin Film Evaporation for Pharmaceutical API Concentration

Definition

Thin film evaporation is a continuous pharmaceutical process technology used to gently concentrate APIs, remove residual solvents from heat-sensitive molecules, and purify biological or chemical intermediates. A thin product film is spread across a heated surface under controlled vacuum conditions, enabling highly efficient solvent removal with minimal thermal stress and very short product residence times — typically seconds to minutes.

Short residence times protect thermally labile and oxygen-sensitive molecules
Efficient heat transfer for precise, consistent concentration targets
Uniform thermal profiles prevent localized degradation and hot spots
Continuous operation supports real-time PAT integration
Linear scale-up from pilot to full commercial pharmaceutical production

Thin Film Evaporation Process

Stage 1

Feed Entry

Stage 2

Film Formation

Stage 3

Evaporation

Output

Concentrate

Key Process Parameters

Residence time: Extremely short

Thermal profile: Uniform

Operation mode: Continuous

PAT compatible: Yes

API Concentration Solvent Distillation Oligonucleotide Processing Botanical Extracts Fermentation Broths Residual Solvent Reduction

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Technology Overview

Pharmaceutical Process Technology Comparison

Selecting the right pharmaceutical process technology depends on your product characteristics, target dosage form, API potency, and containment strategy.

Technology	Primary Application	Key Output	Dosage Forms	Provider
Thin Film Evaporation	API concentration, solvent removal, extract purification	Concentrated liquid or paste at precise solids content	Injectable, liquid, lyophilized, oligonucleotide	LCI Corporation
Wet Granulation	Powder densification, agglomeration, and flowability improvement	Free-flowing, compressible granules	Tablets, hard-shell capsules	LCI Corporation
Extrusion-Spheronization	High-API spherical pellet production	Spherical pellets (0.5–2.0 mm, narrow PSD)	Modified-release capsules, multiparticulates, sachets	LCI Corporation
Drug Pelleting (Rotor-Disk)	Starter-bead layering and functional coating	Uniformly coated spherical pellets	Controlled-release capsules, sachets	LCI Corporation
Pharmaceutical Dust Collection	Source capture at all powder-release points in the facility	Clean GMP environment + recovered product	All solid oral and API manufacturing	Nederman MikroPul

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Common things to know

Frequently Asked Questions

Answers to the most common questions about pharmaceutical extrusion-spheronization, thin film evaporation, wet granulation, and GMP dust collection.

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What is extrusion-spheronization in pharmaceutical manufacturing?

Extrusion-spheronization is a multi-step pharmaceutical pelletization process that converts wet-granulated API-excipient masses into uniform, spherical pellets with narrow particle-size distributions. The process combines wet granulation, extrusion through a precision die plate, and spheronization on a rotating friction plate. The resulting pellets (typically 0.5–2.0 mm) achieve high API loading, excellent flowability, and consistent mechanical strength, making them ideal for controlled-release and modified-release capsule-fill applications and multiparticulate drug delivery systems where uniform functional coating is critical.

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What is thin film evaporation used for in pharmaceutical manufacturing?

Thin film evaporation is used to gently concentrate APIs, remove residual solvents from heat-sensitive pharmaceutical molecules, and purify botanical extracts and fermentation broths. The technology spreads a thin product film across a heated surface under vacuum, achieving efficient solvent removal with very short residence times — protecting thermally labile compounds that would degrade under conventional evaporation. Common applications include oligonucleotide processing, API concentration for downstream formulation, and reduction of residual organic solvents to ICH Q3C guideline levels.

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What containment level is required for pharmaceutical dust collection systems?

Pharmaceutical dust collection containment requirements are set by the Occupational Exposure Limit (OEL) of the active ingredient being handled. Standard GMP applications require hygienic construction with cleanable surfaces and validated capture efficiency at all powder-release points. Highly potent APIs (HPAPIs) with OELs below 1 µg/m³ require dedicated systems with engineered enclosures and HEPA-grade filtration. All pharmaceutical dust collection installations must support GMP cleaning validation documentation and prevent cross-contamination between products and batches through appropriate containment boundaries.

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How does wet granulation improve downstream pharmaceutical manufacturing?

Wet granulation converts fine API powders into free-flowing granules with consistent density, particle size, and compressibility — directly improving tablet compression and capsule-fill operations. Uniform granules reduce tablet weight variation, improve API content uniformity, and enable more predictable powder flow during transfer and containment steps. Well-controlled granulation also significantly reduces airborne dust generation, which simplifies downstream containment requirements and lowers the risk of operator API exposure during handling and transfer operations.

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What is the difference between wet granulation and drug pelleting?

Wet granulation produces irregularly shaped agglomerates used primarily for tablet compression, where precise particle shape is less critical. Drug pelleting via extrusion-spheronization produces spherical particles with a precisely controlled narrow size distribution (typically 0.5–2.0 mm). Pellets are preferred for modified-release dosage forms because functional membrane coatings can be applied uniformly to achieve flexible and reproducible release profiles. Pellet-based products also carry reduced dose-dumping risk compared to monolithic tablets and can be filled into hard-shell capsules or sachets for fixed or flexible dosing.

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Can LCI Corporation support scale-up from laboratory to commercial production?

Yes. LCI Corporation operates a fully staffed Test Center in Charlotte, NC that enables linear scale-up from laboratory and pilot scale to commercial pharmaceutical production. The facility supports process development trials for thin film evaporation, drying, granulation, extrusion-spheronization, and drug pelleting using real commercial-scale equipment. LCI's process engineering team guides clients through testing and generates qualification samples and scale-up datasets to support commercial design documentation and regulatory filing requirements for pharmaceutical manufacturing.

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LCI Test Center — Charlotte, NC

Accelerate Your Pharmaceutical Process Development

The LCI Test Center connects laboratory development with full-scale commercial production — enabling validated, predictable scale-up and regulatory-grade process documentation from a single partner.

Schedule a Test Call +1 704-486-8440

Validate process solutions with real materials on full-scale equipment — not scale-down simulations

Conduct pilot-scale trials for evaporation, drying, granulation, extrusion-spheronization, and drug pelleting

Generate qualification samples and scale-up datasets for commercial design and regulatory submissions

Enable linear scale-up from lab through pilot to commercial — reducing development risk and timeline

Expert process engineering support from LCI throughout development, testing, and scale-up activities

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Long-Term Partnership

Support Across the Full Project Lifecycle

The Nederman Group provides long-term partnership support from initial concept through operational optimization — protecting availability and compliance across multi-decade pharmaceutical manufacturing assets.

Design & Planning

Defining pharmaceutical process and containment concepts from the outset of project development.

Delivery & Installation

Implementing integrated solutions from product formation to powder control and containment.

Service & Maintenance

Maintaining consistent performance in demanding pharmaceutical GMP manufacturing environments.

Monitoring & Control

Maintaining process and containment performance stability over the full installation lifetime.

Optimizing & Upgrades

Adapting systems as products, volumes, and regulatory requirements evolve over time.

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Let's Solve Your Problems

Talk to a Process Technology Expert Today

Connect with LCI Corporation for process technology and scale-up, or with Nederman MikroPul for pharmaceutical dust collection and containment solutions.

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Nederman MikroPul Americas

Hygienic Dust Collection & Containment

GMP-compliant source capture, pharmaceutical dust collection, powder containment, and hygienic system design for API, solid oral dosage, and HPAPI manufacturing facilities.

4433 Chesapeake Dr, Charlotte, NC 28216, USA

+1 704-285-1754

LCI Corporation

Pharmaceutical Process Technology

Thin film evaporation, extrusion-spheronization, wet granulation, drug pelleting, and precision powder feeding. Fully staffed Test Center with scale-up support available in Charlotte, NC.

4433 Chesapeake Dr, Charlotte, NC 28216, USA

+1 704-486-8440

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Get the Pharmaceutical Process Technology & Hygienic Powder Control Brochure

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Pharmaceutical Process Technology and Hygienic Powder Control

Combined Pressure on Modern Pharmaceutical Manufacturing

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Two Brands. One Concept.

From process to powder.From granule to clean air.

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Pharmaceutical Dust Collection & Hygienic Powder Containment

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Nederman MikroPul Pulse Jet Dust Collectors

HPC Dust Collector

Service and Parts

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Extrusion-Spheronization & Drug Pelleting

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Download the Brochure

Ensuring safe pharmaceutical production by protecting people and manufacturing processes with LCI Corporation and Nederman MikroPul

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Wet Granulation & Precision Powder Feeding

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Predictable granules and pellets improve downstream flow, containment, and exposure control. Effective source capture then protects people, preserves product, and supports hygienic operation — forming the foundation for safer, more repeatable pharmaceutical manufacturing.

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Thin Film Evaporation for Pharmaceutical API Concentration

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Pharmaceutical Process Technology Comparison

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Frequently Asked Questions

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Accelerate Your Pharmaceutical Process Development

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Support Across the Full Project Lifecycle

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Talk to a Process Technology Expert Today

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Get the Pharmaceutical Process Technology & Hygienic Powder Control Brochure

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Combined Pressure on Modern Pharmaceutical Manufacturing

Pharmaceutical Dust Collection & Hygienic Powder Containment

Nederman MikroPul Pulse Jet Dust Collectors

HPC Dust Collector

Service and Parts

Extrusion-Spheronization & Drug Pelleting

Download the Brochure

Ensuring safe pharmaceutical production by protecting people and manufacturing processes with LCI Corporation and Nederman MikroPul

Wet Granulation & Precision Powder Feeding

Predictable granules and pellets improve downstream flow, containment, and exposure control. Effective source capture then protects people, preserves product, and supports hygienic operation — forming the foundation for safer, more repeatable pharmaceutical manufacturing.

Thin Film Evaporation for Pharmaceutical API Concentration

Pharmaceutical Process Technology Comparison

Frequently Asked Questions

Accelerate Your Pharmaceutical Process Development

Support Across the Full Project Lifecycle

Talk to a Process Technology Expert Today

Get the Pharmaceutical Process Technology & Hygienic Powder Control Brochure

From process to powder.
From granule to clean air.