ABSTRACT

The Brazilian Cells and Tissues Directive was amended in 2011. It included specific air quality recommendations for rooms where gametes are collected in addition to the existing standards for reproductive laboratories.3 With respect to laboratory ambient air, the BCTD dictates that it should be at least equivalent to ISO class 5 in the critical areas where tissues or cells are exposed to the environment during processing, and recommends one of the following methods to achieve such conditions: (1) biological safety cabinet class II type A; (2) unidirectional laminar flow workstation; or (3) at least equivalent ISO 5 clean room.4 Whenever biological safety cabinets and unidirectional laminar flows are used, background air (clean areas for carrying out less critical stages) should be pressurized. Specifically, minimum standards include an outside and total air volume of 15  and 45  [m3/h]/m2. In addition, supplied air from outside should be filtered for particulates using at least G3 + F8 dust filtration.