Apparatus and method for particle separation in a closed field

A method for providing separated, concentrated particles from a solution containing said particles, comprising:

• providing said solution in a sample container, separated from the environment;
• providing a separation device, coupled to said sample container by at least a first conduit, said separation device having an interior separated from the environment;
• conveying at least a portion of said solution from said sample container to said interior of said separation device along said first conduit while maintaining said portion of said solution in a closed field condition in the absence of exposure of said portion of said solution to the environment;
• retaining at least some of said particles in said interior of said separation device to provide target particles in said separation device;
• providing a target vessel, coupled to said interior of said separation device by at least a second conduit, said target vessel having substantially rigid walls and a plurality of ports, each said port being sufficiently sealable from the environment to define a closed-field vessel, wherein at least a first of said plurality of ports of said target vessel is sealed by a filter;
• conveying a plurality of said target particles from said interior of said separation device to said target vessel while maintaining said plurality of target particles in a closed sterile field condition in the absence of exposure of said plurality of target particles to the environment;
• and
• concentrating said target particles without removing said target particles from said target vessel, to maintain said plurality of target particles in a closed sterile field condition.

A method for contamination-free, repeatable particle separation comprising:

• a) providing a particle separation device having a separation column receptacle and a plurality of controllable valves;
• b) providing a separation device having an affinity-specific substrate, and said separation device having an inlet port and an outlet port;
• c) mounting at least first and second conduits, coupled to said inlet and outlet ports, respectively in operable proximity to said controllable valves to permit selective opening and closing of said conduits;
• d) coupling said conduits to at least a sample source and a target collection vessel, said collection vessel having substantially rigid walls and a plurality of ports, each said port being sufficiently sealable from the environment to define a closed-field vessel, wherein at least a first of said plurality of ports of said collection vessel is sealed by a filter;
• e) controlling said controllable valves to convey contents of said sample source to said separation device wherein at least a first plurality of target particles are retained in said separation device;
• f) controlling said controllable valves to convey said first plurality of target particles to said collection vessel;
• g) removing said sample source, said conduits, said separation device and said collection vessel;
• h) repeating steps b) through g), using a different sample source, conduits, separation device and collection vessel to separate a second plurality of target particles in the absence of contamination by said first plurality of target particles or by the contents of a previous sample source.