Clean rooms were originally defined by the US Food and Drug Administration (FDA) in 1987 with their “Guideline on Sterile Drug Products Produced by Aseptic Processing.” At the time, they defined only two types of clean rooms: “critical” areas (class 100) in which sterilised items were used and “controlled” areas (class 100,000) in which unsterilised items were handled. In September 2004, however, the FDA released new guidelines with their “Sterile Drug Products Produced by Aseptic Processes – Current Good Manufacturing Practice,” which introduces several changes.
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The new guidelines state that aseptic processing should only be used to manufacture sterile drugs when terminal sterilisation is not feasible. This means that, whenever it is possible to do so without harming the product, drugs should undergo terminal sterilisation, wherein the drug is sterilised after being put in its final container. Aseptic processing strives to retain the sterility of the product and the product’s container without the need for terminal sterilisation, and so it requires a clean room.
In the new guidelines, “supporting clean areas” have replaced the previous “controlled” classification. Supporting clean areas are now designated to be those in which unsterilised items, in-process materials, and equipment are prepared or held until transferred. These areas should minimise the particle level contaminants in the product as well as control the microbiological content of components that will later be sterilised.
Separation between different levels of clean rooms and non-clean rooms is essential to the prevention of contamination. The new guidelines recommend directing airflow from areas that need a higher level of cleanliness to areas with lower specifications. To do this, they recommend that clean rooms have a positive pressure differential in comparison to the rooms around them. For instance, they recommend a positive pressure differential of 10-15 Pascals between clean rooms and adjacent rooms that have a different classification. Also, they recommend that supporting clean areas have at least a 12.5 Pascal over pressure to the surrounding non-clean rooms.
Air Change Rate
The rate at which the air changes in a given room indicates how much clean (filtered) air the room is getting. The new guidelines specify that a supporting clean area should have an airflow good enough to maintain 20 air changes per hour. However, while the new guidelines do say that “significantly higher air change rates are normally needed for Class 10,000 and Class 100 areas,” they don’t specify just what the air change rate should be.
Standard Operating Procedures
In the 2004 guidelines, the FDA recommends that written standard operating procedures (SOPs) for the monitoring of microbiological environments address alerts and action levels. This is in addition to the SOPs noting the frequency of air and surface sampling, as well as the details of those samplings (for example, when the samples were taken, the duration of the sampling). The guidelines also recommend that SOPs address the appropriate responses to the given alerts and action levels.
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