Does the manufacture of API’s require the establishment of air quality standards, HVAC systems specifications to insure no dust migration during the charging of components used in API manufacturing from one reactor to another?

Section 4.2 of the guidance states that “adequate ventilation, air filtration and exhaust systems
should be provided, where appropriate. These systems should be designed and constructed to
minimize risks of contamination and cross-contamination and should include equipment for
control of air pressure, microorganisms (if appropriate), dust, humidity, and temperature, as
appropriate to the stage of manufacture. Particular attention should be given to areas where APIs
are exposed to the environment.”
If the API process is essentially a closed-system, this would minimize the need for establishment
of air quality standards and specific area classifications.