STANDARD OPERATING PROCEDURE FOR THE VALIDATION OF CLEAN ROOM AREAS

1.0    PURPOSE :

To describe a standard operating procedure for the validation of clean room areas.

2.0    SCOPE:

    The standard operating procedure describes in detail the method of testing of air flow velocity, air change profile, pressure and particle count of clean room areas at various locations in the plant.
    
3.0    RESPONSIBILITY:

    The responsibility of the validation of clean room areas of various locations in the plant lies with the staff of rank not lower than the Maintenance Engineer with the assistance of out side agency.

    The responsibility of preparation, review and approval of the standard operating procedure lies with the Manager – Maintenance, Head of Production and Head of   QAD respectively.

4.0    METHOD:

4.1    Air flow velocity and Air change profile test:

4.1.1    As the don’t have the facility out side agency shall attend for this test.

4.1.2    Thermo Anemometer or propeller type Anemometer sensitive to lower velocities shall be used to conduct this test.

4.1.3    Air flow velocity & Air change profile test shall be carried out where supply air grills are located.
    
4.1.4    Check the velocities at 2” below or away from the grill.
 
4.1.5    No object shall be present below the anemometer while taking the reading except the built in equipment. 
    
4.1.6    Each measurement shall be taken for at least 15 seconds. 

4.1.7    Each grill shall be checked at least for 3 to 4 test spots.

4.1.8    Each grill velocity shall be averaged.
    
4.1.9    Add all the No. of terminals/grills placed in the specific room and shall be averaged and multiplied  with the grill effective area to achieve the room air flow to tap.

4.1.10    The sum of air flow in the room shall be multiplied by 60 and divided by the volume of the room, thus to achieve the air changes in the specific room. 
    
4.1.11    Record the readings in Annexure-I.
    
4.1.12
Acceptance Criteria:
    
    The air changes shall be established by calculation and it should not be less than the design qualification of particular area. 

                     
4.1.13    Frequency: Air flow testing shall be carried out once in a year for all classes.

4.2    Pressure control / pressure difference test:
    
4.2.1    Manometer inclined / magnehelic gauges shall be used for testing. 
    
4.2.2    All HVAC and laminar flow work station shall be in operation while conducting pressure control test.
    
4.2.3    All doors shall be closed in the connected and inter connected areas.
    
4.2.4    Locate low pressure sensitive areas for test probing.  So as to achieve the operation result.  
    
4.2.5    Open and close the doors to check the pressure reaches the base line within 30 seconds.  Repeat the test for reliability of the system.
    
4.2.6    Record the readings in the Annexure-II.
    
4.2.7    As per the design qualification.

4.2.8    Frequency: 
The differential pressure test shall be carried out once in a year for all classes. 

4.3
Particle count test:
    
4.3.1    Particle count test shall be conducted by authorized personnel only.

4.3.2    Particle count test shall be carried out only after the velocity and overall penetration tests are completed successfully. 

4.3.3    The particle count test shall be conducted at static and dynamic level of the clean room.
    
4.3.4    Particle counter probe shall not be disturbed while conducting particle count test.
    
4.3.5    The clean room area particle count shall be about 30” – 40” above the floor level.

4.3.6    The laminar air flow work area count shall be at about 4” above the work table.

4.3.7    Met one instrument shall be used for the particle count of clean air.
    
4.3.8    Record the readings in Annxure-III.   
    
4.3.9    The cleanliness classification levels shall be defined by FS 209E and ISO 14644-1.
The following table compares FED 209E to the ISO 14644-1 clarification.  

4.3.10    The precise count levels required by ISO 14644-1 and FS 209E for each classification by particle size, are as given below.

4.3.11    Acceptance Criteria:  As per Federal Standard / ISO, 0.5 micron particles count should not be exceeded.

4.3.12    Frequency of testing of particle count shall be done as per ISO/Federal standards as given below.  

Standard operating procedure, validation of clean room areas, engineering