Failure is not an option: Why sterility testing is so important



In this eBook we look at why sterility testing is such an important requirement and address the role of your environmental monitoring program and how it is critical to the success of your sterility testing, product quality and reputation.

Furthermore, we examine the challenges of standard sterility testing through the lens of the Harmonised Pharmacopoeia to bring you practical processes to minimise risk. 

Sections include

The sterility testing principle

One of the most established microbiological tests currently being used in pharmaceutical manufacture. We delve into its purpose, history and the culture media used during the test. 

Standard membrane filtration vs. direct inoculation as sterility testing methods 

Both these categories are discussed for a deeper understanding while unpacking problems related to standardised tests with a 14-day incubation period. 

European pharmaceutical regulations: What they mean for business 

This section covers the expectations outlined by the pharmacopoeia and EU GMP and the aseptic conditions under which this quality control measure needs to be performed.  

Key considerations in your sterility testing process 

Here we cover the five-step procedure for validation tests which need to be passed for sterility tests to be viable. 

What happens in the event of a sterility test failure? 

Insights into what you need to do should this happen to you. 

9 practical steps to minimise risk of contamination 

These steps can be used as your checklist to ensure minimal risk of any contaminant entering your facility 

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