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Food and Drug Regulations

Version of section C.04.417 from 2006-12-14 to 2014-10-22:

  •  (1) In respect of the storage of source plasma, including storage during transportation, a fabricator shall ensure that the storage environment

    • (a) is designed to maintain a temperature of -20°C or colder; and

    • (b) remains consistently at a temperature of -20°C or colder.

  • (2) If the temperature of the environment rises above -20°C, the fabricator shall record the following information:

    • (a) the reason for the elevated temperature;

    • (b) the source plasma affected; and

    • (c) the final disposition of the source plasma.

  • (3) If the temperature of the environment rises to between - 20°C and +10°C, the fabricator shall clearly and permanently label the container of the source plasma with the statement “Source Plasma — Salvaged” or “Plasma destiné au fractionnement — recyclé”.

  • (4) Subsection (3) does not apply if the temperature of the environment rises to between -20°C and -5°C for a single period lasting less than 72 hours.

  • (5) If the temperature of the environment rises above +10°C, the fabricator shall dispose of the source plasma.

  • (6) Paragraph (1)(b) and subsections (2) to (5) do not apply in respect of the storage of source plasma during transportation, if the transportation is not conducted by the fabricator.

  • SOR/78-545, s. 1
  • SOR/85-1022, s. 8
  • SOR/2006-353, s. 1
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