Dear Sirs,

Thanks for your kind reply to my previous question. Well, We're manufacturing blood bags with anticoagulant, so i need to know the perfect method for sterilization after filling of the anticoagulants......and the effect of Eto "ethylene oxide" on blood bags filled already with anticoagulant

Talkin' about pasteurization of blood bags after packaging, Is steam sterilization enough or should we make pasteurization. And if possible more specifications on how and when should we start pasteurization; which step during manufacturing and storage is the best.

Thanks...
Dr. Riad Gohar

Dr. Gohar

Sterilization of blood bags is not difficult. If they are in a permeable package, and the bag has open vents, then ethylene oxide can be used. If the bag is plugged, you will need to consider irradiation methods. Once you put the anticoagulant inside, process selection and development becomes more complicated. You cannot irradiate a drug, or else you create a new compound that may behave differently. Also, you will have to perform serious studies if you attempt to use ethylene oxide. EtO will react with some drugs and may cause complications.

My suggestion is to validate a sterilization method and process for the empty blood bags. Then administer the anticoagulant at the point of use during the blood draw procedure. Don't expose the drug to any sterilization process.

Paul J. Sordellini