A.G. Coombs has an established reputation for designing and delivering sophisticated mechanical services to the pharmaceutical industry. When a multi-million dollar mechanical works package had to be designed, constructed and commissioned for cleanroom pharmaceutical manufacturing spaces in a challenging fast-tracked program, the A.G. Coombs Group brought its collective experience to collaborate on a holistic solution.

“It’s not unique for A.G. Coombs to design a mechanical works package for a complex laboratory or pharmaceutical plant and it’s not unique to work to a very tight timeframe,” says Scott Dolman, Project Manager for A.G. Coombs. “However, designing from a blank canvas and successfully delivering an operational system in a period less than 12 months qualifies this project as highly unique.”

Early collaboration sets the foundation

The 3800 sqm facility located in the outer eastern Melbourne suburb of Mount Waverley, is a Good Manufacturing Practices (GMP) manufacturing facility for the Paragon Care Group. The company is made up of a range of successful brands, delivering world-class technology and support across all healthcare sectors including the manufacture of lifesaving in-vitro diagnostics at this Melbourne plant.

Specialist pharmaceutical, laboratory and cleanroom builders, Bio Construct was commissioned by Paragon Care Group to undertake construction of the facility. Previous collaborations between Bio Construct and A.G. Coombs had resulted in a series of successful laboratory and cleanroom project outcomes.

“Given our trusted relationship with Bio Construct, we could confidently provide our full design capability to fast-tracking the early stages before the contract award was finalised,” says Simon Fragiacomo, Sales & Estimating Manager for A.G. Coombs.

Engineering innovation shines

“Because of our experience with complex pharmaceutical facilities,
A.G. Coombs’ engineering team was able to quickly establish air distribution concepts allowing us to commence the equipment and services procurement process with supplier and subcontractor partners,” remarks Simon.

The Heating Ventilating and Air Conditioning (HVAC) and mechanical services were designed to meet the international Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-Operation Scheme Guide to Good Manufacturing Practice: Manufacturing Principles for Medicinal Products which specifies the non-negotiable delivery of clean environments. This includes the requirement for High-Efficiency Particulate Air (HEPA) filters, high air exchange rates and room pressure regimes to control the flow of air and ensure cleanliness. Detailed system design and documentation modelling, and the ordering of major equipment was completed within the space of just two months.

“Pharmaceutical and medical device process equipment also requires dedicated mechanical services infrastructure; this could be plant for chilled water, heated water, air exhaust, compressed air or a combination,” says Raymond Quach, Senior Engineer for A.G. Coombs. “These services must also be integrated with their thermal loads addressed.”

“The Quality Assurance (QA) regime for the design and construction of services is onerous for GMP facilities. The project generated multiple detailed schedules, tracking system elements down to the smallest 15mm diameter isolation valve.”