The invention provides a unit operation formed by a device and its use for continuous virus inactivation of a continuous flow of a process fluid. The unit operation formed by a device comprises a single inlet at one end and an outlet at the opposite end and at least one HFI, characterized in that the HFI further comprises at least one installation.

An injectable aqueous implant formulation, and processes for making and using the formulation, wherein the injectable aqueous implant formulation has been sterilized by gamma-ray or X-ray-irradiation and can be extruded through a tapering system and an 18 gauge (0.838 mm inner diameter) 25.4 mm long cannula with a force not exceeding 60 N, which comprises 25-45 w/w % of a mixture of nanocrystalline hydroxyapatite particles derived from natural bone having a size of 50 to 200 m as determined by sieving and fragments of naturally crosslinked fibrous collagen material that pass through a 0.5 mm sieve, whereby the w/w ratio of nanocrystalline hydroxyapatite to collagen is from 1.8 to 4.5, which contains at least 0.05% (w/w) ascorbic acid.

An injectable aqueous implant formulation, and processes for making and using the formulation, wherein the injectable aqueous implant formulation has been sterilized by gamma-ray or X-ray-irradiation and can be extruded through a tapering system and an 18 gauge (0.838 mm inner diameter) 25.4 mm long cannula with a force not exceeding 60 N, which comprises 25-45 w/w % of a mixture of nanocrystalline hydroxyapatite particles derived from natural bone having a size of 50 to 200 m as determined by sieving and fragments of naturally crosslinked fibrous collagen material that pass through a 0.5 mm sieve, whereby the w/w ratio of nanocrystalline hydroxyapatite to collagen is from 1.8 to 4.5, which contains at least 0.05% (w/w) ascorbic acid.

A method and a system for producing a change in a medium. The method places in a vicinity of the medium an energy modulation agent. The method applies an initiation energy to the medium. The initiation energy interacts with the energy modulation agent to directly or indirectly produce the change in the medium. The energy modulation agent has a normal predominant emission of radiation in a first wavelength range outside of a second wavelength range (WR2) known to produce the change, but under exposure to the applied initiation energy produces the change. The system includes an initiation energy source configured to apply an initiation energy to the medium to activate the energy modulation agent.

Methods for processing tissue are provided. In some embodiments, the methods comprise methods for decellularizing tissue samples by applying high hydrostatic pressure to the tissues samples. In some embodiments, the methods comprise methods for thawing tissue samples and/or reducing the bioburden in a sample by applying high hydrostatic pressure to the tissue samples.

The present invention relates to an X-ray irradiator for single blood bags, comprising: an X-ray irradiator main body provided with a chamber configured to safely hold a single blood bag therein and an X-ray tube configured to irradiate the chamber with X-rays; a loading part configured to load the blood bag; and a transfer part configured to transfer the blood bag between the loading part and the chamber to which X-rays are to be emitted. The X-ray irradiator for single blood bags according to the present invention can treat a single blood bag with X-rays, such that treatment optimized for a small amount of a blood bag can be performed, and a system configuration can be simplified by using an X-ray tube.

A method for sterilizing by X-rays an assembly containing a single-use device intended to receive a biopharmaceutical fluid, comprising: placing a plurality of dosimeters, repeatedly passing the assembly in front of the X-ray radiation window, according to a first face then according to a second face of the assembly, at several irradiation power-time pairs (PTi), followed by mapping the radiation dose; and determining an optimum power-time pair (PTopt) for which the mapping reveals that all dosimeters have recorded a radiation dose above a minimum sterility dose (Dmin), and for which the dosimeter associated with a fragile element of the single-use device records a radiation dose below a maximum dose (Dmax) defined as being the dose from which the X-ray irradiation deteriorates the fragile element.

An X-ray irradiation system includes a support for an object requiring decontamination, a first source of irradiation directed to a top side of the object; a second source of irradiation directed to a bottom side of the object; and a controller configured to control a dose rate and a time of each of the first source and the second source to optimize decontamination of the object. A method of irradiating an object is further disclosed.

The present disclosure is directed to a method of making a composition by combining a vehicle, e.g., a single phase vehicle, and an insoluble component comprising a beneficial agent, and sterilizing the composition using ionizing radiation prior to use, wherein the beneficial agent is stable following exposure to a sterilizing dose of ionizing radiation. Related compositions and methods are provided.

A phosphor composition, containing one or more phosphors having on a surface thereof a coating selected from silica, diamond, and diamond-like carbon, wherein the one or more phosphors are configured to emit radiation upon interaction with an initiation energy.