Case Study 2 - Development Laboratory Equipment

EMAIL US | SITEMAP

A large UK generic company was repositioning itself to enable the site to develop new compounds for product introductions and undertake small scale batches as well as optimise older well established products away from the main large production streams.

The company reviewed the market and could not justify the investment for new equipment. Epsilon-Equipment were tasked to single source the project and provide “as-new”:

	Fluid bed multiprocessor

	Tablet coater

	High shear mixer

	Ancillary equipment

First class donor equipment was quickly sourced and required upgrading to comply with ATEX, CE and full cGMP. In summary the project required the design and execution of:

	Detail design & facilities/utilities impact - full fixed cost

	Full CE/ATEX risk assessment and mitigation plan developed

	Certified decontamination and replacement material certification (stainless 316L)

	General equipment upgrade and new inlet air handler

	New control system with S7 PLC WinCC to GAMP5 and fully approved DQ package

	Tablet coater overhaul and new machine guarding

	Upgraded fluid bed and internal re-polishing

	High shear mixer interlocks and controls with new inverter drives

	Full installation of the equipment and project management

The execution of the task took four months to complete at approximately a third of the cost of all-new equipment.