Bioburden test is used to determine the quantity of viable microorganisms present in the washing aqueous samples deriving from the equipments, instruments and production lines that are subject to cleaning activities.
Sterility tests are performed in ITELPHARMA’s microbiological quality control laboratory with the method of membrane filtration using a filtering system placed into a Laminar Flow Cabinet.
Analysis are performed following proper validation method, and they verify absence of bacteriostatic and fungistatic effects in the product.
The test is performed by filtering the product onto a membrane with a porosity of 0.45μm contained inside sterile and disposable device, previously installed on the filtering system. The membrane is then washed with a specific fluid and then it is transferred on plate containing R2A culture medium. The plate containing the R2A medium is placed inside the incubator at a temperature of 32.5°C for 5 days.
At the end of the 5 days of incubation, the results of the analysis are delivered to the customer by way of a suitable analysis certificate.