Food and Drug Regulations

C.04.420 (1) Containers used for human plasma, whether integrally attached or separated from the original blood container, shall not be entered by the fabricator for any purpose except for filling with human plasma.

(2) Containers used for human plasma shall be uncoloured and hermetically sealed and shall permit clear visibility of the contents.

(3) Containers and their components used for human plasma shall not interact with the plasma under normal conditions of storage and use so as to alter the safety, quality, purity or potency of the plasma and shall provide adequate protection against external factors that may cause deterioration or contamination.

(4) Containers used for human plasma shall, before being filled, be marked or identified by a number or some other symbol that will relate it directly to the donor.

(5) Containers for human plasma collected from a donor referred to in section C.04.419 shall, after being filled, be handled, stored and packaged separately from other containers.