By John Erdner, Portfolio Manager, Fill-Finish, SP Scientific
In the pharmaceutical industry, containers used for injectable drugs must be clean, sterile and pyrogen free. For vials, this preparation process normally is comprised of vial washers and depyrogenation tunnels or ovens. The purpose of a vial washer is to remove particulate matter and microorganisms from the inside of vials. The ovens or tunnels are used for depyrogenation of the vials to reduce the quantity of endotoxins to an acceptable level.
Vial washers use water for injection (WFI) to remove particulate from the inside and the outside of the vials. The removal process is accomplished by dilution, however temperature and water pressure will improve the efficiency of the washing cycle through thermal expansion and flushing action during the cleaning process.
There are several methods for validating the cleaning effectiveness of washers, but all include some sort of contamination and then an evaluation of the effectiveness of the removal of the contamination. Different pharmaceutical companies have different preferences in test methods (salt tests, particulate tests or riboflavin test) but it is important to define the expected results so they are achievable and evaluate the cleaning effectiveness of the important parts of the vial.
This paper explains the pros and cons of different washer systems.