Bioburden test

We determine the quantity of viable microorganisms present in the bulk solution of radiopharmaceutical finished products and washing aqueous samples

Bioburden test of radiopharmaceuticals bulk solutions

Bioburden test is used to determine the quantity of viable microorganisms present in the bulk solution of an injectable radiopharmaceutical product before sterilization (for terminally sterilized radiopharmaceuticals) or filtration (for radiopharmaceuticals products aseptically).

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 two membranes with a porosity of 0.45μm contained inside sterile and disposable devices, previously installed on the filtering system. The membranes are then washed with a specific fluid and then they are transferred on plates containing respectively TSA (Tryptic Soy Agar) and SDA (Sabouraud Dextrose Agar) culture media. The plate containing the TSA medium is placed inside the incubator at a temperature of 32.5°C for 5 days while at 22.5°C for the plate containing the SDA medium incubation applying the same incubation time.

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.

Bioburden test of washing aqueous samples

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.

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