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Automated Batching and Solvent Handling for API Coating Media

Client

Global Pharma Client

Completion time

22 weeks

An undisclosed client had approval for the introduction of a new pharmaceutical compound to their site in Ireland. This required highly specialised, automated control of a multi-layer API solvent-based coating medium for a sustained release profile.

Automated Batching and Solvent Handling for API Coating Media

Project Brief

Epsilon were tasked with designing and providing proof of concept for automated batching mixing vessels for solvent-based mediums, prior to full-scale implementation.

System Requirements

The system required a fully automated wash-in-place process, which had to be designed from scratch. This included the use of specialist pressure distribution and high-energy wash nozzles.

The concept considered vacuum transfer under nitrogen, as well as the careful and controlled addition of solvents and API (Active Pharmaceutical Ingredient) beneath the liquid line.

Problem Solving and Re-engineering

The client had previously attempted a similar setup, but significant design flaws including vessels that were the wrong size and shape led to failure. Epsilon re-engineered these components to resolve the issues.

Epsilon’s experienced process engineers quickly addressed the issue of solvent evaporation to ensure constant levels of API in the mix.

Proof of Concept

A 1/10th scale, 100-litre non-GMP vessel was built to demonstrate proof of concept. This step gave the client project team the confidence to proceed to the 1000-litre scale.

Control and Automation

The equipment was designed and built with a FactoryTalk Control system, including data acquisition, historian functionality, and recipe management.

Preassembled Installation

To mitigate risk and minimise installation time, the complete assembly comprising three vessels, interconnections, hygienic pipework and valve manifolds, API additions, nitrogen distribution, and associated safety systems was prebuilt in Epsilon’s assembly hall.

The system was delivered fully wired and running, complete with switchgear and PC/HMI interfaces.

Challenges Overcome

  • Forensically reviewing an unworkable third-party design and identifying root causes of failure
  • Delivering an alternative, effective design
  • Building a functional proof-of-concept system
  • Designing and installing a novel condenser to eliminate solvent evaporation
  • Developing a FactoryTalk control system with full SCADA capability
  • Completing the build and installation under very tight timelines

Key Results

  • ✅ The equipment was installed and commissioned ahead of time
  • ✅ On target budget of Euro 1.28 million
  • ✅ Success measured by an order for a second complete system

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