Industrial Hydrogenation Plants for APIs & Pharma Manufacturing

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.