Haemologic Biotech, has announced plans to construct ISO 8-classified cleanrooms at its Sydney facility. This strategic development aims to enhance the company’s manufacturing capabilities and ensure compliance with stringent international standards for life science and biopharmaceutical products.
ISO 8 cleanrooms, as defined by the ISO 14644-1 standard, maintain a controlled environment with a maximum of 3,520,000 particles per cubic meter for particles ≥0.5 microns in size. Such environments are essential for the production of biopharmaceutical devices and components where contamination control is critical. Implementing ISO 8 cleanrooms will enable Haemologic to produce a broader range of high-quality products, meeting the demands of both domestic and international markets.