A device is for sterilization by electron beam irradiation of flexible bags, in particular flexible bags of the type that can contain solutions of human plasma proteins for therapeutic use. A sterilization method includes irradiating flexible bags by electron beam irradiation. An in-line method for filling flexible can use the sterilization device and method.

Electronic devices for treating a biological fluid and methods of operating the devices are disclosed. In some embodiments, the electronic device includes a plurality of non-safety critical components, a first controller communicatively coupled to the plurality of non-safety critical components, a plurality of safety critical components, and a second controller communicatively coupled to the plurality of safety critical components. In some embodiments, the electronic device includes a treatment interface.

A method is for sterilization of flexible bags containing human plasma protein solution with electron beam. The method includes emitting at least one electron beam with energy between 400 and 500 keV. After approximately 10 nsec to 1.5 sec, a second electron beam pulse is emitted with an energy of at least 4 MeV.

The invention relates to a modular irradiation device having a main module and at least one support cassette, the support cassette being insertable into a receptacle of the main module. The support cassette has at least one pump, and the main module has at least one pump actuator, these being arranged such that the pump is actuatable with the pump actuator when the support cassette is inserted into the receptacle of the main module.

A sterile pharmaceutical dosage form which comprises an ester capped lactide polymer, glycolide polymer or a lactide-glycolide copolymer hypercompressed with an active pharmaceutical ingredient wherein said sterile pharmaceutical dosage form has been sterilized with an electron beam and a method of preparing said sterile pharmaceutical dosage form.

Electronic devices for treating a biological fluid and methods of operating the devices are disclosed. In some embodiments, the electronic device includes a plurality of non-safety critical components, a first controller communicatively coupled to the plurality of non-safety critical components, a plurality of safety critical components, and a second controller communicatively coupled to the plurality of safety critical components. In some embodiments, the electronic device includes a treatment interface.

This invention provides a method of sterilising an S-nitrosothiol, for example S-nitrosoglutathione, without reduction of purity by more than about 5.0% through degradation. The invention allows sterile S-nitrosothiol or a sterile pharmaceutical pre-composition comprising S-nitrosothiol, wherein the S-nitrosothiol is in dry solid form, to be produced. The sterile pharmaceutical pre-composition is mixed with one or more diluents, excipients, carriers, additional active agents, or any combination thereof, for example sterile saline, to prepare a pharmaceutical composition of S-nitrosothiol for use.

The present disclosure provides methods for reducing bioburden on a tissue product, as well as the tissue products produced according to the disclosed methods. In particular, the disclosure relates to methods of electroporating tissue in the presence of one or more bactericides in order to reduce bioburden. The methods allow for reduced exposure to electrical energy and/or bactericide while reducing bioburden.

A sterilization, disinfection, sanitization, or decontamination system having a chamber defining a region, and a generator for creating a free radical effluent with reactive oxygen, nitrogen, and other species and/or a vaporizer. A closed loop circulating system without a free-radical destroyer is provided for supplying the mixture of free radicals from the generator mixed with the hydrogen peroxide solution in the form of the effluent to the chamber. The system is used in sterilizing, disinfecting, sanitizing, or decontaminating items in the chamber or room and, with a wound chamber, in treating wounds on a body. The wound chamber may be designed to maintain separation from wounds being treated. Various embodiments can control moisture to reduce or avoid unwanted condensation. Some embodiments can be incorporated into an appliance having a closed space, such as a washing machine. Some embodiments may include a residual coating device that deposits a bactericidal coating on sterilized items.

The present invention relates to methods for sterilizing active pharmaceutical ingredients, which may be micronized, using radiation.