C: System
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Collection, processing and/ or storage system
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0 1.4.1 | Not specified ? | |
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1 1.6.1 | Closed system Closed | To be used, if all steps of preparation of the product satisfy the criteria of a closed system. If there is at least one open system step during preparation, "closed system" does not apply. Sterile docking is assumed to be a "closed system" procedure. |
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2 1.4.1; 1.6.1 | Open system Open | To be used, if during preparation at least one step does not satisfy the C1-, C3- or C4-critera. |
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3 1.4.1 | Sterile filtrated SterFilt | Sterile filtrated. |
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4 1.5.2 | Clean room CleanR | Open system under clean room conditions |
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