Pharmaceutical
Regulatory pressures and advancements in technology are changing the face of the pharmaceutical industry. The industry has very specific requirements in both the delivery and content of capital works where the ability to combine attention to detail and compliance along with performance, safety and quality standards is crucial.
M.E. Engineering has extensive experience in specialised pharmaceutical process plants providing services ranging from design, procurement, construction management to commissioning and qualification support. Our approach to project execution is based upon the ISPE Guidelines and in full compliance with the code of Good Manufacturing Practice with project documentation designed to suit regulatory requirements at all times.
Areas of Work
Clean Utilities
We have significant recent experience with clean utilities which includes leading the design, construction, commissioning, and qualification of two new clean utilities’ plants for a large pharmaceutical client in Sydney as part of a significant capital expansion. Systems included Purified Water, Water for Injection and Clean Steam generation, storage, and distribution along with integration with field users.
Solution Preparation -
Including Sterile Filtration and Aseptic Processing
M.E. Engineering partnered with a large pharmaceutical company undertaking a significant capital expansion over the last eight years to design and support the installation, commissioning, and qualification of seven new advanced sterile solution preparation suites. M.E. Engineering also supported the site’s minor capital projects including the upgrade of older solution preparation suites and other minor upgrades.
Veterinary Plant
M.E. Engineering was engaged to deliver a turnkey design and construction project for a formulation and packaging plant of veterinary products in Sydney, Australia.
Pharmaceutical Grade Gas Systems
We have worked in a range of pharmaceutical gases applications. Recent projects include the design and construction of a new pharmaceutical grade Compressed Air generation, treatment, storage, and distribution system. We also have experience in the expansion of existing systems including Compressed Air and Nitrogen distribution systems amongst others.