Risk assessment for Environment monitoring sampling location identification.

Environmental monitoring programme is the key factor to check and  control of contamination level. 
Viable monitoring location should be determined based upon a assessment of risk.
Assessment of risk based upon personal own knowledge.

Viable sampling location identification Risk Based Assessment study:

·     Sampling locations should be selected on the following parameters 

1.    Product is directly exposed on the Environment.

2.    Probability of finding contamination is maximum.

3.    High traffic areas.

4.    Air flow is not proper.

5.    Select difficult clean areas.

6. Contamination source it means (Poor cleaning procedures.Personnel movement,  Poor HVAC system,Equipment movement and Utilities).

7. Human contamination such as human air, dandruff, finger dabs and breathing are major contamination source.

 Each sampling location proper justification is required (Rationality).

Clinical and Translational Research Center (CTRC)

Protocol Risk Assessment and Monitoring Guidelines

 Level of Risk:

There are four levels of protocol risk.

1.    Level -1 (Minimal Risk)

2.    Level-2 (Minor increase over minimal Risk)

3.    Level-3 ( Moderate Risk)

4.    Level-4 (High Risk)

      1.  Level -1 (Minimal Risk):

·    Ordinarily encountered in daily life during the performance of routine activity.

·    No greater than minimal Risk.

·    Requires minimal intensity monitoring.

2.  Level-2 (Minor increase over minimal Risk)

·         Minor increase over minimal Risk.

·         Low intensity monitoring 

      3.  Level-3 (Moderate Risk)

       ·         Moderate Risk.

        ·         Greater than minimal risk but are not considered the high risk.

        ·         There is a medium risk.

        ·         Required moderate intensity monitoring.

        4.  Level-4 (High Risk)

        ·         High risk

        ·         High intensity monitoring.

Non Viable Sample Location:

Ø  ISO 14644 part -1 is a use full guideline to maintain the particles clean room.

Ø  This documents provide the standards for the clean room classification.

Old Version : 

Formula is mentioned calculate the Clean room Number of sampling locations

NL  = √A

Where

NL = Minimum number of sampling locations 

√A = Floor of the clean room (1m²)

Ex:

NL   = 15ft  X 12 ft  = 180 ft²

√A = 1m²

1m³ = 35.31ft³

1m² =10.7639ft²

= 180 ft² /10.69ft²/ m²       = 16.72 m²

=√16.72 m²

= 4 sampling locations / ft^2.

New Version : 

Ø  Finally  2015 version is released and following the Major changes.

 1.    ISO 14644-1  “Classification of air cleanliness” to “classification of air cleanliness by            partical   contamination”

 2.    Previous sampling location calculation using  NL  = √A formula, but revision directly 

       mentioned number of location.

       No Calculation are required to determine the number of locations.

      3.   Particles of 5 µn in ISO class 5 have been removed from the limit 

             (previous 29 particals in ISO Class-5).

      4.    The length of tubing used in particle counter should be less than 1 meter.

       5.    Remaining as it is.

       Where a room area is not listed in the look -up table, the next largest size' is selected.

   

       This method has generally led to increase in particle count locations.

Related : Difference between Viable monitoring and Non viable monitoring