A-A-51496A
Bags shall be shaped to permit centrifugation in a standard 1000 ml trunnion cup. The two primary bags shall each be provided with two blood outlet ports, of a standard length and diameter, containing an easily puncturable diaphragm that forms a leakproof, air-proof, seal that shall require no more than normal manual force to remove. As an alternate, transfer bags may also possess outlet ports.
All ports shall be fully compatible with a Blood Administration Set. The primary bags shall have a horizontal slot to suspend the bag for administration.
Each primary bag shall be supplied with a permanently applied “commonality label” describing product to be “Red Blood Cells, Deglycerolized” product number 06400. This label shall be printed according to the latest edition of FDA ‘S “Guidelines for Uniform Labeling” to include manufacturer and lot number.
Additions to this label by the processing facility shall consist of, but not limited to, name of processing activity, unit number and unit blood type.
The tubing connecting the “Y” junction and each primary bag shall bear a different set of at least ten indelibly imprinted numbers along the tubing for the purpose of dividing the donor tubing into segments for pilot samples if required. The center distance between numbered segments shall be between 2-1/2 and 3-1/2 inches.
The spike shall be suitably protected with a plastic cover to maintain sterility, and form a leak-proof, air-tight seal with a Wash Bowl and Waste Bag Set.
If a roller shut-off clamp is provided, the security of the roller in the clamp body shall be tested as follows:
The roller clamp shall be removed from the set together with a piece of tubing approximately one inch longer than the clamp body. The tubing shall be present in the roller clamp in its normal position with a 1/2 inch length extending from each end of the roller clamp. The clamp, see Figure 1, shall be held vertically, with the large end down, over a supporting gap so that the roller, if forced out of the body, is free to fall. A polished steel rod is applied to the top of the roller, so that the roller is able to rotate in the course of the test and the vertical downward force required to separate the roller from the clamp body is measured.
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