Pressure Limit for a Sterile Injectables Area
The pressure limit for a Sterile Injectables Area is crucial to maintain a contamination-free environment. According to WHO guidelines, the recommended differential pressure range for sterile areas is between 10 to 15 Pascal. This pressure difference prevents contamination and cross-contamination, ensuring the sterility of the cleanroom.
In a Sterile Injectables Area, a positive pressure difference is maintained, meaning the inside of the area is at high pressure, and adjacent areas like airlocks or corridors have low or negative pressure. This pressure difference facilitates the movement of air from inside to outside, preventing the entry of microbes and contaminants.
To achieve this pressure difference, an HVAC system is used to create differential pressure. The system should be equipped with appropriate filters, such as HEPA, to maintain the required cleanliness level.
As per Health Canada,
Adjacent rooms of different grades should have an air pressure difference of at least 10 Pascals (guidance value). Particular attention should be paid to protecting the critical zone.
Here are the Grades of Sterile Injectables Areas:
- Grade A: Equivalent to an ISO 5 environment, with a maximum permitted number of particles ≥ 0.5 μm/m³ of 3,520.
- Grade B: Equivalent to an ISO 7 environment, with a maximum permitted number of particles ≥ 0.5 μm/m³ of 352,000.
- Grade C: Equivalent to an ISO 7 environment at rest and ISO 8 in operation, with a maximum permitted number of particles ≥ 0.5 μm/m³ of 352,000 and 3,520,000, respectively.
- Grade D: Equivalent to an ISO 8 environment at rest, with no predefined particle classification in operation.
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