ABSTRACT
Perhaps a little surprisingly, the US cGMPs do not have a section, or subsection on specific cGMPs for sterile products manufacture. There are no more than a few references, made almost in passing, in other contexts. For example:
(c ) Operations shall be performed within specifically defined areas of adequate size. There shall be separate or defined areas or such other control systems for the firm’s operations as are necessary to prevent contamination or mix-ups during the course of the following procedures: …
(10) Aseptic processing, which includes as appropriate: (i) Floors, walls, and ceilings of smooth, hard surfaces that are easily
cleanable; (ii) Temperature and humidity controls; (iii) An air supply filtered through high-efficiency particulate air filters
under positive pressure, regardless of whether flow is laminar or nonlaminar;
(iv) A system for monitoring environmental conditions; (v) A system for cleaning and disinfecting the room and equipment to
produce aseptic conditions; (vi) A system for maintaining any equipment used to control the aseptic
conditions.
