The proper design of low-temperature storage facilities ensures that sensitive biological materials are maintained under conditions providing maximum storage stability.

Properly designed and operated low-temperature storage facilities ensure that the handling of sensitive biological materials at low temperatures does not compromise stability (see Guide E 1565).

Properly designed low-temperature storage facilities ensure that adequate safeguards are provided to prevent untoward events from compromising the stability of sensitive biological materials.

1.1 This guide covers recommended procedures for developing and maintaining low-temperature storage facilities for freezers with mechanical refrigeration.

1.2 This guide covers recommended procedures for developing and maintaining low-temperature storage facilities for freezers cooled with liquid nitrogen.

1.3 This guide does not cover practices for preservation by freezing which are covered in Practice E 1342.

1.4 The values stated in SI units are to be regarded as standard.

This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.