A biological sterilization indicator for evaluating the effectiveness of a sterilization process includes a cap containing a culture medium, a container containing a concentration of microorganism, and a breakable barrier attached to the cap to encapsulate the culture medium therein. The breakable barrier is formed from a multilayer structure including an aluminum layer and a sealing layer. The biological indicator is configured such that the breakable barrier may be broken at a selected time by engaging the cap and the container at an activated position to introduce the culture medium into the container.

A biological indicator for testing the efficacy of sterilization or disinfection processes of closed environments or confined spaces, the biological indicator comprising a carrier; biological material supported on or embedded in the carrier; and a carrier container comprising a body and a cap. The carrier is fixed within an inner space of the cap, the cap being able to be placed in an open position completely exposing the carrier and the biological material to the closed environment or confined space to be disinfected. A method for determine the efficacy of a process of sterilization or disinfection of closed environments or confined spaces, preferably by means of an enzyme and a fluorescence compound, using said biological indicator.

A culturing apparatus (10) is an apparatus for culturing a culture medium with which an airtight container (35) is filled. Such a culturing apparatus (10) is provided with a container holding unit (12) that holds the airtight container (35) and a motion imparting unit (15) that imparts physical motions from the outside of the airtight container (35) to the airtight container (35) held on the container holding unit (12).

A SCBI useful in ambient air pressure systems is disclosed. The SCBI includes a body which serves as the culture tube, a glass media ampoule, an inoculated stainless steel disc positioned on the top of the glass media ampoule so that the spores are close to the top/opening of the SCBI, filter paper on the top of the body and overlying the disc, and a cap.

A sterilization system includes a vial, a carrier of microorganisms disposed in the vial, and a fluid management system having an output connectable to the vial for delivering a liquid chemical sterilant and a neutralizer thereto. Additionally, a growth medium may be delivered to the vial such that the vial and growth medium may assessed for a change to a visual characteristic indicative of sterilization inefficacy.

A SCBI useful in ambient air pressure systems is disclosed. The SCBI includes a body which serves as the culture tube, a glass media ampoule, an inoculated stainless steel disc positioned on the top of the glass media ampoule so that the spores are close to the top/opening of the SCBI, filter paper on the top of the body and overlying the disc, and a cap.

A recovery medium that is particularly suited for following enzymatic reactions where the fluorescent product is excited at a wavelength of 320 to 370 nm and emits at a wavelength of 420 to 460 nm is provided. The recovery medium is clear in color and does not contain the combination of compounds that participate in the Maillard reaction. The recovery medium is suitable for self-contained biological indicator systems.

Embodiments described herein provide for the production, isolation, and/or collection of cellular product(s) released or secreted from cells. Cells may be expanded in the intracapillary (or extracapillary) space of a bioreactor of a cell expansion system with media. Cells may release cellular products into the fluid space of the bioreactor. Examples of such released cellular products include extracellular particles, such as extracellular vesicles (EVs). To collect the extracellular particles released from the cells being expanded, as opposed to any extracellular particles from other sources, a washout procedure may be used to eliminate any serum proteins prior to collecting the released extracellular particles from the expanding cells. The released cellular products may be collected or concentrated through the control of outlet parameters, while nutrients may reach the cells through the diffusion of media through a semi-permeable membrane, for example. The released cellular products may then be harvested.

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.

Provided herein are isolation processes and the associated hardware to allow fluid streams to be isolated from a sterilized system (e.g., a sterile process vessel) that contains a sterile process. The isolation processes described herein allow for continuous removal of fluid streams (e.g., waste streams, liquid containing recombinant therapeutic proteins) from a sterilized system (e.g., a biological manufacturing system), which provides for less manual manipulation of the sterilized system and a decreased risk of contaminating the sterilized system.