With the growing scrutiny on sterile compounding pharmacies and a push towards external accreditation and cGMP, USP <71> Sterility Tests is an extremely important chapter to understand and comply with. The chapter discusses two forms of sterility testing: membrane filtration and direct inoculation. It details two appropriate culture media that may be used for the sterility tests. Fluid thioglycollate medium used primarily for culture of anaerobic bacteria and soybean casein digest medium suitable for both fungi and aerobic bacteria. Another critical feature of the chapter is the incubation temperature and time, which are important factors for chapter compliance. In a future post we will further discuss the aforementioned topics and other components of the chapter, including method suitability tests, and how these concepts will increase in prevalence across our industry going forward.
At the core of the chapter are Tables 2 and 3 which define the minimum quantity to be tested and the number of articles to be tested for each batch that requires sterility testing. ITL Consulting has created a free resource for the industry, which is two simplified version of these tables and an excel document that calculates the appropriate number articles and quantity to be tested for each batch. These documents focus on specifically on liquid sterile preparations, including parenterals, ophthalmics, and non-injectable products.
For a free copy of this resource, please email questions@itlconsulting.net or click the link below and complete the form - Subject: USP <71> Calculator