Pharmaceutical API Reactor

The Challenge

A pharmaceutical company in India needed a 2,000L reactor for producing an intermediate compound for their API (Active Pharmaceutical Ingredient) line. The process involved multiple reaction steps with different temperature requirements, and the equipment needed to meet GMP (Good Manufacturing Practice) standards for subsequent regulatory inspections.

The key requirements were:

• ✓ Internal surface finish of Ra ≤0.4μm for cleanability
• ✓ Full material traceability with certified mill reports
• ✓ CIP (Clean-in-Place) capability
• ✓ Temperature range: -10°C to 180°C
• ✓ Documentation package for regulatory submission

Our Solution

We designed a 2,000L jacketed reactor with the following specifications:

Technical Specifications

Key Design Features

• ✓ Semi-coil jacket for enhanced heat transfer (35% better than flat jacket)
• ✓ Electropolished interior and exterior surfaces
• ✓ Sanitary tri-clamp connections throughout
• ✓ CIP spray balls for self-cleaning capability
• ✓ Double mechanical seal with barrier fluid system
• ✓ PT100 temperature sensors at multiple points
• ✓ Level gauge with sanitary connection

Documentation Package

For pharmaceutical clients, documentation is as important as the equipment itself. We provided:

• ✓ Material certificates (EN 10204 Type 3.1)
• ✓ Weld procedure specifications (WPS) and qualifications
• ✓ NDT reports (RT, PT, MT as required)
• ✓ Hydrostatic test report
• ✓ Surface finish verification reports
• ✓ As-built drawings and P&ID
• ✓ Operation and maintenance manual
• ✓ Certificate of conformity

The Result

The reactor passed the customer's incoming inspection without any observations. It has been in operation for 14 months in their pharmaceutical production facility, running multiple batches per week. The client reported no cleaning-related issues and no product cross-contamination between batches.

The documentation package was accepted by their QA team without requesting additional information — something the client noted was not guaranteed with other suppliers.