Sterility tests verify the absence of microbial contamination potentially harmful for humans in raw materials and finished products.
Sterility tests are performed in ITELPHARMA’s microbiological quality control laboratory inside an isolator connected to a hydrogen peroxide vaporiser in a classified pharmaceutical grade D room.
Analysis are performed following proper validation method, and they verify absence of bacteriostatic and fungistatic effects in the product.
The test is performed by way of product filtration onto two membranes with a porosity of 0.45µm contained inside devices called “canisters”. The membranes are then washed with a specific fluid and then the “canisters” are filled with TSB or FTM culture media. The TSB “canister” is placed inside the incubator at a temperature of 22.5°C for at least 14 days while at 32.5°C for the FTM canisters incubation applying the same incubation time.
During tests execution, particulate and microbiological monitoring are performed to demonstrate compliance to the environmental conditions required (Pharmaceutical Class A) of the isolator system during operation.
At the end of the 14 days of incubation, the results of the analysis are delivered to the customer by way of a suitable analysis certificate.