Safety of Human Cells, Tissues and Organs for Transplantation Regulations

Marginal note:Requirements

65 The facilities of an establishment that distributes cells, tissues or organs must be constructed and maintained to permit all of the following:

• (a) the carrying out of all of its activities;

• (b) the efficient cleaning, maintenance and disinfection of the facilities in a way that prevents contamination and cross-contamination;

• (c) environmental and microbiological monitoring and control appropriate to the areas where its activities are carried out; and

• (d) controlled access to all areas where its activities are carried out.