Biological Indicator (BI) Analysis is a method used to verify the effectiveness of sterilization processes by using microorganisms that are highly resistant to sterilization methods. This analysis is critical for ensuring that sterilization processes meet regulatory requirements and effectively eliminate contaminants, ensuring the safety and sterility of your products and equipment.
Quantus tests both self-contained vials and BI strips/discs. We can handle various types of biological indicators including Geobacillus stearothermophilus and Bacillus atrophaeus, which are commonly used in healthcare, pharmaceutical, and lab equipment sterilization processes.
The total incubation and analysis time typically ranges from 48 hours to 7 days, depending on the type of biological indicator used. Interim results are available at the 48-hour mark, with final results provided after the full incubation period.
Quantus provides detailed reports based on the analysis of color changes or turbidity in the biological indicators. A pass means no microbial growth was detected, while a fail indicates the presence of growth, requiring further investigation into your sterilization process.
Yes, Quantus adheres to industry standards such as USP <55> and follows rigorous internal procedures to ensure our BI Analysis meets the highest quality and regulatory requirements for sterilization verification.