Abstract: A method for ensuring a microbiological purity of a single-use device for carrying out a biotechnological process, the single-use device including at least one gamma-sterilizable component which is formed from materials suitable for a sterilization by gamma radiation, and at least one non-gamma-sterilizable subunit which contains a material unsuitable for a sterilization by gamma radiation. Both the component and the subunit each have an area that comes into contact with a process medium when the biotechnological process is carried out.

Abstract: A distributor assembly, which is provided in particular for a separation unit of a modular process device arrangement, including a fluid distributor device having a plurality of fluid ports, wherein the fluid distributor device can selectively establish and block fluid communications between the fluid ports. The distributor assembly further includes a connecting element and a retaining element. The connecting element is adapted to be attached to one of the fluid ports, and the distributor assembly includes an associated mounting slot at the fluid port. The mounting slot is adapted to the shape of the retaining element such that the retaining element can be inserted into the mounting slot up to a defined retaining position, in which the retaining element engages the connecting element and fixes it in place.

Abstract: A modular device for a fixed arrangement and interconnection of individual separation units and/or first functional units for performing one or more unit operations in a biotechnological process. The modular device includes a plurality of distributor caps provided for attachment to the separation units and/or first functional units. The distributor caps each have: a fluid distribution mechanism having a working connection and at least two supply or discharge connections, wherein the fluid distribution mechanism can assume at least two defined switching positions; connection mechanisms for establishing a flow communication between a fluid inlet or outlet of the separation unit or the first functional unit and the working connection of the fluid distribution mechanism; coupling mechanisms for establishing a rigid mechanical coupling and a flow communication with an adjacent distributor cap; and an interface for changing the switching positions of the fluid distribution mechanism.