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Sterility Control

Test for microorganisms on sterilized products


We perform sterility controls in accordance with Ph Eur 2.6.1 / USP in LAF benches (EU grade A) placed within an EU grade B classified area.Sterility control is performed on samples that are required to be sterile or free from microorganisms, for example injectables, medical device or similar. The number of units or volume to be tested depends on the batch size or volume of one unit and is described in the pharmacopoeia.

When performing a sterility control, the sample is introduced into two different broths, TSB (Tryptic Soy Broth) for aerobic microorganisms and Thio (Thioglycollate Broth) for anaerobic microorganisms. The samples are incubated for 14 days at 20-25 °C (TSB) and 30-35 °C (Thio).

Before analysing a product in routine, a Method Suitability Test (MST) is performed. This test verifies the method of choice by pointing out possible antimicrobial properties of the product. Validation is done by inoculating the product with < 100 CFU of microorganisms, defined by the pharmacopoeia. Alternatively, the sterility control must be validated at each occasion by performing a bacteriostasis/fungistasis by demonstrating growth of specific microorganisms after completed sterility control.

The technique used for a sterility control is dependant upon the properties of the sample:

Membrane Filtration: For filterable products this is the method of choice. Inhibitory substances are removed from the sample by filtration through a 0,45 µm filter. The filter is then incubated in the broth. Filtration and filling of the broth is done in an EU grade A area.

Direct Innoculation: If the sample is non-filterable and doesn’t show any inhibitory effects it is simply inoculated directly into the broth before incubation. Inoculation is done in an EU grade A area.

Analysis result, lead time

Normal time requirement from sample arrival to analysis report-out are approximately 15-19 business days but can vary depending on sample characteristics.