Industrial Hydrogenation Plants for APIs & Pharma Manufacturing
Hydrogenation Technology in API Production
Critical Parameters in API Hydrogenation
Successful API hydrogenation depends on precise control of multiple process parameters that significantly impact reaction outcomes:
- High Pressure: Typically ranging from 2-16 bar, pressure management directly affects reaction kinetics, selectivity, and operational + environmental safety considerations.
- Catalyst Type and Loading: Selection between heterogeneous (Pd/C, Pt/C, Nickel) catalysts based on reaction specificity requirements.
- Temperature Control: Precise temperature management (usually between 20-150°C) influences reaction rates and product selectivity while preventing potential side reactions.
- Mixing Efficiency: Critical for gas-liquid mass transfer, uniform catalyst distribution, and heat transfer.
- Cleanability & GMP Compliance: Process plants that are easy to clean
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Discover the essentials of agitated hydrogenation processes, explore innovative design concepts for agitated hydrogenation reactors, and learn about cutting-edge modular hydrogenation plant technology – all centered around API production.
Small-Scale Hydrogenation Unit for Pharmaceuticals
Hydrogenation Reactor
Design Data
Temperature: -25 to 150 °C
Pressure: FV / 16 bar
Filling Volume: 20 to 500 L useful volume
Material Reactor: Stainless Steel, Hastelloy (C22)
Cooling: Double Jacket
Mixer: VISCOPROP or GASJET
Pharma Design: GMP and Good Cleanability
Cleaning: Includes Cleaning-in-Place (CIP)
Qualification: IQ and OQ
Gas-Liquid Reactor with Interchangeable Impeller System
Self-Aspirating turbine for volume gassing:
GASJET
- Self-aspirating impeller
- Draws gas through hollow shaft
Re-disperses gas- Gas is finely dispersed into liquid
- Improves mass transfer
PHASEJET
- Eliminates flat blade turbine issues under gas
- Blades shaped to reduce flow separation
- Stable power draw (gassed vs. ungassed)
- Over 2× higher flooding limit
- Boosts overall efficiency
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Modular Process Components
Preparation Tank
- Moveable via palette trucks
- Agitator for suspending / dissolving Solids
- Available in different volumes / materials
- Optional lock for catalyst loading
Pump Station
- Integral to the reactor skid and control system
- Safe and controlled transfer of product
- From preparation tank to reactor
- From reactor through filter to product receiver
Filter
- Installed on a trolley
- Safe and contained catalyst filtration
- Various filter media available
- Connected to control system
Transfer Tank
- Movable via palette trucks
- Available in different volumes and materials
Heating / Cooling Unit
- Powerful H/C-unit tailored to reactor system
- Short heating / cooling cycle
- Safe cooling during reaction
- Integral to control system
Scrubber
Knock Out / Blow Out
Small-Scale Hydrogenation Unit
Transforming Production with Compact Modularity
- Advanced, modular hydrogenation plant tailored for pharmaceuticals (e.g. Active Pharmaceutical Ingredients (APIs), Active Diagnostic Ingredients (ADIs), small molecules, Drug Substances
- Hygienic design enables safe cleaning and prevents product cross-contamination and avoids irregular FDA audits
- Modular design allows for customizable configurations, providing tailored solutions for your production
- Designed for small and medium batch sizes
- Exceptional process flexibility and efficient production for various quantities
- Equipped with advanced safety mechanisms and automated controls for precise production processes
FAQ's
What are challenges in API and pharma manufacturing plants?
In API and pharmaceutical manufacturing, several challenges related to cleaning and cleanability are frequently overlooked or underestimated during plant design and operation. Key issues include:
- Use of unsuitable or non-validated cleaning agents: If cleaning agents and solvents are not approved by the customer or are unsuitable, this can compromise cleaning validation and leave unknown residues.
- Hidden gaps and hard-to-reach areas: Non-flush welded transitions, horizontal surfaces, or poorly designed connections can promote residue buildup and biofilm formation.
- Surface roughness: Surfaces that are too rough (> Ra 0.8 µm) increase the risk of product adhesion and make cleaning more difficult.
- Spray shadows: Poor geometry or incorrect placement of CIP nozzles can create areas that are not reached by the cleaning solution.
- Design dilemma between cleanability and performance: Internal components such as heat exchangers or baffles improve process efficiency but make cleaning more difficult and increase the risk of contamination.
- Unsuitable or overly complex connections: Poorly designed or non-hygienic connections can trap residues and complicate cleaning.
- Lack of cleaning validation: Without methods such as riboflavin testing, cleaning blind spots often remain undetected.
At EKATO, we address these challenges with targeted design principles: flush-welded transitions, optimized surfaces, intelligent CIP nozzle placement, modular systems, and validated cleaning processes—ensuring maximum safety and GMP compliance from the very beginning.
How can I avoid typical mistakes when planning a hydrogenation plant?
When planning a hydrogenation plant, several challenges often arise that can lead to problems:
- Unclear definition of the cleaning task (scrubber systems): Organic and inorganic components require different cleaning concepts. Choosing the wrong washing liquid or scrubber type can significantly reduce efficiency.
- Complexity due to multi-level skids (layout planning): Additional levels increase the effort for piping, insulation, and accessibility. Building requirements are often considered too late, which can lead to costly adjustments.
- Solid dosing & containment: Handling catalysts impacts both cost and safety. External pre-dosing is often more economical and safer than full integration.
Many of these issues can be avoided through early, structured planning and by involving experts. EKATO supports you with modular solutions, comprehensive consulting, and practical experience from numerous projects.
What risks arise if cleaning is neglected in hydrogenation plants?
Neglecting cleaning and cleanability during the planning and operation of hydrogenation plants can lead to serious and costly problems—many of which only become apparent when it’s too late:
- Risk of failed cleaning validation: Using unsuitable or non-validated cleaning agents can compromise product safety and regulatory compliance, resulting in unknown residues and failed audits.
- Hidden contamination sources: Poorly designed connections, non-flush welds, and hard-to-reach areas can trap residues and biofilms, increasing the risk of cross-contamination between batches.
- Difficult or incomplete cleaning: Rough surfaces, spray shadows (areas not reached by CIP nozzles), and complex internal components make thorough cleaning nearly impossible, threatening both product quality and process uptime.
- Costly retrofits and downtime: Overlooking cleanability in the design phase often leads to expensive modifications, production delays, and unplanned shutdowns later on.
- Inefficient processes: Choosing the wrong cleaning concept or layout (e.g., for scrubber systems or multi-level skids) can reduce operational efficiency and increase maintenance effort.
- Safety and compliance risks: Inadequate handling of solids (like catalysts) or lack of cleaning validation (e.g., no riboflavin testing) can endanger both personnel and product integrity.
These pain points highlight why it’s crucial to address cleaning and cleanability from the very beginning. Early, structured planning and expert support—like EKATO’s modular solutions and consulting—help you avoid these risks and ensure long-term GMP compliance and process reliability.
