The Brief

A major pharmaceutical manufacturer operating both BSL2 and BSL3 containment facilities needed to build reliable, compliant waste treatment infrastructure across two distinct streams: liquid effluent from process areas, and solid biological waste from containment. Both programmes had to meet strict regulatory requirements for decontamination prior to disposal and both had to be engineered to handle the physical realities of high-containment waste, including slurries and mixed biological materials.

The Challenge

BSL3 waste treatment is not a standard engineering problem. The streams involved are variable in composition, can include viable biological agents, and the consequences of incomplete decontamination are serious. Standard effluent treatment designs — built around dilution or physical separation — are not sufficient. The plants had to be engineered to guarantee decontamination, not just reduce concentration.

The solid waste side introduced an additional complexity: the client needed a shredder-autoclave unit which is a combined shredding and sterilisation system that processes waste in a single contained cycle. No pharmaceutical plant in the region had installed one before. There were no local precedents for commissioning, validation, or regulatory acceptance.

Our Approach

We acted as Engineering Project Leader across both programmes responsible for design, design reviews, execution, and commissioning from concept through to handover.

For the effluent treatment programme, we designed and delivered three separate ETPs, each sized and configured for its specific waste stream and containment boundary. The process design centred on validated thermal and chemical decontamination — not dilution — with each plant engineered to demonstrate compliance at the point of discharge. Slurry handling was designed into the process from the outset, not added as an afterthought.

For the solid waste programme, we delivered multiple autoclave units across both containment classes and led the engineering, procurement, and commissioning of the shredder-autoclave unit. Because there was no existing playbook for this at a pharmaceutical site, we worked directly with the equipment manufacturer and the client's quality and regulatory teams to develop the validation approach. The commissioning protocol was written from first principles and accepted by the client's QA function and, ultimately, by the relevant regulatory body.

Results

€17M total project value
3 ETPs designed, executed, and commissioned across BSL2/BSL3 boundaries
First shredder-autoclave installation at a pharmaceutical manufacturing site in the region validation approach accepted first time
Facility operational
100% regulatory decontamination compliance achieved on commissioning sign-off across all units
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