Performance Qualification for Total Particulate Count as per different regulatory agencies – Technology Trends – Express Pharma Pulse

Performance Qualification for Total Particulate Count as per different regulatory agencies

Definition: Total number of particles present per cubic feet area is known as Total particulate count. The particulate matter may be present in the form of dust particles, fiber, microorganisms’ etc. These particles can affect the quality of the pharmaceuticals.

Purpose: The purpose of determination of the Total Particulate Count is to check that whether the total particulate count is in given limits or exceeding for the given class of area.

Different regulatory agencies gives different limits for Total Particulate Matter for different class of areas. The Total Particulate Count must be within the given limit to carry out operations almost in aseptical conditions. The Total Particulate Count shall always be maintained within the given limit.

Contributed by Dhananjay Thube, S Vishweshwar & R M Gupta

Class 100 Monitoring Table:

STANDARDS

LIMITS

US Federal Standard 209 E

3,500 per cubic meter (less than 0.5 micrometer) or 100 per cubic feet.

USP appendix 1116

100 per cubic feet. (less than 0.5 micrometer)

European Union (at rest, static)

3,500 per cubic meter (equal to or above 0.5 micrometer) or 0 per cubic meter (less than 5 micrometer)

European Union (operational, dynamic)

3,500 per cubic meter (equal to or above 0.5 micrometer)

(When area is used for the filling of sterilized products)

or 0 per cubic meter (less than 5 micrometer)

European Union (operational, dynamic)(When area is used for transfer of close containers of sterilized products)

350,000 per cubic meter (equal to or above 0.5 micrometer) or 2,000 per cubic meter (less than 5 micrometer)

ISO146441

3,520 per cubic meter (equal to or above 0.5 micrometer) or 29 per cubic meter (5.0 micrometer)

Class 10,000 Monitoring Table:

STANDARDS

LIMITS

US Federal Standard 209 E

353,000 per cubic meter (less than or equal to 0.5 micrometer) or 10,000 per cubic feet.

USP appendix 1116

10,000 per cubic feet (less than or equal to 0.5 micrometer)

European Union (at rest, static)When the area is used for filling of sterilized products)

350,000 per cubic meter (equal to or above 0.5 micrometer) or 2,000 per cubic meter (less than 5 micrometer)

European Union (operational, dynamic) (When area is used for the filling of sterilized products) ISO146441

3,500,000 per cubic meter (equal to or above 0.5 micrometer) or 20,000 per cubic meter (less than 5 micrometer) 3,52,000 per cubic meter (equal to or above 0.5 micrometer) or 930 per cubic meter (5.0 micrometer)

Class 100,000 Monitoring Table:

STANDARDS

LIMITS

US Federal Standard 209 E

3,530,000 per cubic meter (less than or equal to 0.5 micrometer) or 100,000 per cubic feet

USP appendix 1116

100,000 per cubic feet (less than or equal to 0.5 micrometer)

European Union (at rest, static) When the area is used for the preparation of solution and components for filling)

3,500,000 per cubic meter (equal to or above 0.5 micrometer) or 20,000 per cubic meter (less than 5 micrometer)

European Union (operational, dynamic) (When area is used for the preparation of solution and components for filling) ISO146441

Not defined 3,520,000 per cubic meter (equal to or above 0.5 micrometer) or 29,300 per cubic meter (5.0 micrometer)