Particle counting

Either you have a choice or no choice.

You have to place the sensor not less than 15cm from LAF and not more than 30cm from the LAF at filling zone.
Ideal place is 15 to 20Cm from LAF for online monitoring.

I would like to know which guideline states so? If possible please share the guideline Ref and I would like to comment on this aspect after reading the guideline.

Regulatory Guidance
Rules for powder filling have been issued by both the FDA and EU GMP standards.

The EU GMP Annex 1 Regulations state:

[b]8. Cleanrooms and clean air devices should be routinely monitored in operation and the monitoring locations based on a formal risk analysis study and the results obtained during the classification of rooms and/or clean air devices.

  1. For Grade A zones, particle monitoring should be undertaken for the full duration of critical processing,including equipment assembly, except where justified by contaminants in the process that would damage the particle counter or present a hazard, e.g. live organisms and radiological hazards. In such cases monitoring during routine equipment set up operations should be undertaken prior to exposure to the risk. Monitoring during simulated operations should also be performed. The Grade A zone should be monitored at such a frequency and with suitable sample size that all interventions, transient events and any system deterioration would be captured and alarms triggered if alert limits are exceeded. It is accepted that it may not always be possible to demonstrate low levels of ≥5.0 μm particles at the point of fill when filling is in progress, due to the generation of particles or droplets from the product itself.[/b]

The FDA has a similar philosophy:

Some operations can generate high levels of product (e.g., powder) particles that, by their nature, do not pose a risk of product contamination. It may not, in these cases, be feasible to measure air quality within the one-foot distance and still differentiate background levels of particles from air contaminants. In these instances, air can be sampled in a manner that, to the extent possible, characterizes the true level of extrinsic particle contamination to which the product is exposed. Initial qualification of the area
under dynamic conditions without the actual filling function provides some baseline information on the non-product particle generation of the operation.

[COLOR="#000000"]Practical Application of Guidance :

In practice, this means that the validation of the process to determine the environmental control must be done with operators ‘pretending’ to fill actual bottles, bags, or other vessels.

During simulation:
-The particle counter is turned ON.
-The containers will move into the Filling machine under LAF or RABS.
-The operator will move as if powder was flowing in accordance to the normal operating procedure.
At least 40-60 minutes of fill simulation is recommended in order to establish a particle counts baseline before actual product is introduced.

Prior to the filling of product:
The operator ensures the particle counter is ON and runs it for about 30 minutes before filling inorder to prove two things:

  1. The baseline originally established in the “simulated” run is replicated during that 30 minutes, and
  2. No adverse conditions are produced as a result of setting up the equipment.When the initial 30-minute baseline period is complete:
    -The particle counter is turned OFF.
    -Filling of product begins.

The only data available to ensure that process conditions have not changed are the differential pressure results and the airflow velocity results. If these do not change, it is acceptable to believe the particle conditions also have not changed and any presence of particles is as a result of the product itself – which is acceptable. When filling is finished the particle counter should be turned back ON again.

This will demonstrate that no residual contamination exists and that the environment was able to restore baseline conditions. Run this post-test for about 30 minutes. It is very important to establish these baseline results since there will be no actual particle counting taking place during the filling process.

To Mr.Bansal : Try to post such questions in required subject blogs. Never post such serious things in General discussions.Its like a table manners. Please learn.Its a request.[/color]