In 2022, a remarkable chapter in Australia's biotechnology research unfolded with the opening of the CSIRO National Vaccine and Therapeutics Lab in Clayton, Victoria. This state-of-the-art facility has been designed to play a pivotal role in the research and development of vaccines and drug treatments, ultimately contributing to Australia's innovative potential in the life sciences sector. At the heart of this ground-breaking lab, stainless steel has emerged as a critical component, ensuring the facility's functionality, quality, and safety.
The facility’s primary objective is to transform vaccine and drug candidates into products that can be manufactured onshore in substantial quantities for clinical trials. It enables the development and production of a variety of clinical-grade biologicals, including recombinant proteins and peptides, and viral products under good manufacturing practice (GMP) regulations.
Pure Piping: A key player in lab construction
One of the essential contributors to the facility’s successful construction is ASSDA Member Pure Piping. Pure Piping was engaged to deliver three critical work packages, which included the procurement, fabrication, delivery, testing, documentation, and handover of various systems:
- Critical Piping Package:
Water for injection distribution, instrument air distribution, pure steam distribution, temperature control units, nitrogen gas supply and distribution (including gas manifold), waste collection (including treatment tank package), carbon
dioxide gas supply and distribution (including gas manifold), waste transfer, oxygen gas supply, and distribution (including gas manifold) plant steam, process air distribution, and the installation of 18 clean room general service outlet panels. These systems are vital for maintaining the lab's stringent quality standards.
- Water for Injection Tank Package:
Pure Piping was also responsible for the tank's design and supply, a crucial element in vaccine and therapeutic production. To ensure the highest standards of quality and compliance, ASSDA Member and Accredited Fabricator Furphy Engineering was engaged to design, manufacture and test the 500L vessel to AS1210-2010 Pressure Vessels and other pharmaceutical design and specification requirements as outlined by Pure Piping and its team of consultants.
- Mechanical for Process Package:
Process cooling water (including the purchase and installation of the chiller), plant steam (including the purchase and installation of the plant steam boiler), compressed air (including the purchase of two compressors and an air receiver), the installation of principal-supplied specialist equipment and the supply and installation of a drying cabinet. These systems are essential for the lab's day-to-day operations.
The role of stainless steel
Stainless steel played a central role in ensuring the quality and safety of the new CSIRO facility. The production of clinical-grade biologicals requires stringent processes and performance demands in the equipment delivered. Stainless steel offers strong resistance to corrosive chemicals and can withstand high temperatures, high pressures, as well as aggressive cleaning and sterilisation regimes.
The project utilised a substantial amount of stainless steel, including:
1,182m of 316/316L grade cold-drawn seamless pharmaceutical tube specified to ASTM A269 Standard specification for seamless and welded austenitic stainless steel tubing for general service. Internal surface finish to ASME BPE SF4, i.e. max of 0.38µm Ra by mechanical polish followed by electropolishing.
1,051 fittings in 316L grade in accordance with AS1528 Stainless steel tubes and tube fittings for food processing and hygienic applications.
18 general service outlet panels.
- 730 items of stainless steel equipment, valves, and instruments.
The food-grade stainless steel tube and fittings for the project were supplied by ASSDA Member Prochem Pipeline Products.
Stringent testing and certification
The lab's gas services underwent rigorous testing to ensure cleanliness and containment. High-purity nitrogen was employed for pressure testing, and the compressed air supply was tested for particles to 0.1µm of a micron to determine the purity classes as specified in ISO 8573-1: Compressed Air. Moisture testing of the compressed air was also performed to ISO 8573-4 to confirm a dew point less than 3o C.
Orbital welding techniques were used to meet the high-quality weld requirements of bioprocessing equipment and deliver superior corrosion resistance. All welds were meticulously logged and documented, and all materials were clearly identified and certified with 3.1 material certificates.
"Stainless steel offers strong resistance to corrosive chemicals and can withstand high temperatures., high pressures, aggressive cleaning and sterilisation regimes."
A boost to Australia's biotechnology landscape
Funded by the federal and Victorian governments along with its industry partners, the CSIRO National Vaccine and Therapeutics Lab is a major boost to Australian research capacity and advanced manufacturing in biotechnology. It bolsters sovereign capability in vaccine and therapeutics development, enabling companies to produce these vital products onshore.
Stainless steel’s role in the project exemplifies the criticality of advanced materials and precision engineering in advancing biotechnology research. This facility stands as a testament to Australia’s commitment to innovation and scientific process, paving the way for ground-breaking discoveries in the biomedical sector on a global scale.
This article was featured in Australian Stainless Magazine 79 (2024).