Luina Bio’s state-of-the-art facilities ensure that their products not only meet stringent manufacturing standards but also surpass them
The manufacture of medicinal products is subject to special requirements to minimize the risks of contamination from pollutants such as dust, airborne microbes, aerosol particles and chemical vapours. Cleanrooms help to ensure that small particles do not adversely affect the manufacturing process by offering an environment for controlling the level of contamination.
Cleanrooms are used extensively in the pharmaceuticals, biotech, medical device and life sciences industries to reduce particulate contamination and to control other environmental parameters, including temperature, humidity and pressure.
Cleanrooms are classified according to how clean the air is inside them, with the class specifying the level of cleanliness the room complies with according to the quantity and size of particles per metric volume of air.
The primary classification standard is ISO 14644-1. The standard covers the cleanroom classes ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9, with ISO 1 providing the highest level of cleanliness and ISO 9 the lowest. Each ISO class represents a ten-fold difference in cleanliness (e.g., an ISO 3 cleanroom is ten times “cleaner” than an ISO 4 cleanroom).
For comparison, ambient air in a typical city environment contains around 35,000,000 particles per cubic metre and 0.5 microns and larger in diameter, which corresponds to an ISO 9 cleanroom.
The table below presents the ISO classes for the level of airborne particulate cleanliness.
Servicing the life sciences sector
Located in Brisbane, Australia, Luina Bio’s 1,200m2 manufacturing facility houses modular cleanroom laboratories with ISO 8 fermentation suites and support areas and ISO 7 purification and final product isolation suites.
Using the latest cleanroom technologies, the facility meets the highest manufacturing standards. It provides clients with a competitive advantage by offering highly customized solutions that also safeguard consumer interests by providing products that are safe, reliable and trustworthy.
Also, Luina Bio continually reviews and improves its processes and equipment to ensure the facility meets with the manufacturing standards demanded by regulators.
The table below presents an overview of Luina Bio’s manufacturing facility.
* The fermentation and isolation suites are also supported by an ISO 8 storage areas ranging from -80°C to controlled ambient temperatures for raw material, in process material and finished product.