EnCata provided medical device engineering services to design and prototype a custom laminar flow box for a GMP production line. The product features cleanroom-compliant design and precise airflow control for sterile manufacturing.
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The customer from the pharmaceutical industry approached EnCata with an urgent need to quickly design and produce a batch of laminar boxes for their new pharmaceutical plant. A small but important omission in the plant’s clean area design endangered the project’s commissioning and GMP certification plans. I.e., the plant procurement failed to deliver the clean hoods that should fit in the developed and nearly finished floor plan.
The client thus demanded a very aggressive 1.5 month deadline for the rapid development and production of clean hoods. We enthusiastically took on the challenge.
The laminar clean chamber is an independent piece of equipment that creates laminar flow inside the clean area in a plant’s weighing area.
In addition to the specific air quality and dimensions requirements, it was required to assemble the hoods on-site as the plant line construction was already completed and there was no gate to facilitate placement of the preassembled hoods in the building.
The designed system had a filter clogging control built-in, SCADA-compatible electronics software and automatic regulation of the clean area’s airflow rate. The electronic control unit provides the human interface for the system control as well as a remote system performance control.
Need someone to engineer a GMP-compliant system for your facility? Feel free to get in touch with us. We will supply you with a precise estimate promptly!
It took 1 month for EnCata to develop the engineering documentation and an additional 2 weeks to produce, validate, and test the first hood prototype. 5 more units were produced and delivered within the next 2 weeks, enabling the client to achieve their initial plant commissioning plans.
required to finish the task
delivered as part of this project in 30 working days
required to design the documentation for the production start
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