BioBall is available for three pharmaceutical testing methods:
1. Growth Promotion Testing
The pharmaceutical industry is required to perform QC with controls in the range of 10 to 100 cfu for growth promotion and sterility testing. BioBall has two products that are ideal for these QC applications:
BioBall SingleShot designed for a single inoculation with unprecedented precision and BioBall MultiShot 550 designed for 10 inoculations - with low variance
2. Sterility Assurance Testing
Sterility assurance is a critical responsibility of pharmaceutical industry microbiologists. Sterility testing is a demanding application requiring method suitability tests, growth promotion tests, and validation studies to satisfy the requirements of the United States, European and Japanese Pharmacopoeias. For these demanding tests and validations, reliable quantitative microbiological controls with exceptional accuracy and precision are required to deliver confidence in the results and satisfy applicable regulatory requirements. BioBall products, incorporating unique patented technologies, are developed, manufactured, tested and certified to deliver confidence and convenience in sterility assurance applications.
3. Antimicrobial Effectiveness Testing
Pharmaceutical and cosmetic preparations often require antimicrobial activity to prevent microbial proliferation or to limit the effects of contamination. The Pharmacopoeias require testing these products for the efficacy of antimicrobial preservation (e.g. USP 51, EP 5.1.3, JP19). Preparing consistent inocula for these tests can be laborious and is often unreliable, necessitating time consuming repeat assays.
BioBall MultiShot 10E8 is ideal for this application and simplifies preparation and provides a precise inoculum.
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