Swab sampling locations

How should be the swab sampling locations decided for a particular equipment?
As i understand these should be difficult to clean but accessible also.
For example a Rapid mixer granulator shall have which locations for sampling?

Thanks

[quote=sims]How should be the swab sampling locations decided for a particular equipment?
As i understand these should be difficult to clean but accessible also.
For example a Rapid mixer granulator shall have which locations for sampling?

Thanks[/quote]

Dear sims,

to choose the sampling points in the equipment we use the following criteria:

  • Possibility to be sampled. A completely inaccessible point cannot be sampled.
    _ Representativeness: Points are chosen which can be reasonably regarded as “worst case” locations or representative for a bigger surface in the equipment.
  • Experience: The locations which, in the experience of the people who perform the cleaning operation, are the hardest to clean points.
  • Accessibility: Points which are difficult to access for cleaning and/or inspection.

Find attached the sampling points for our Diosna P-600 high shear mixer. It is in spanish, but i think it is self explaining.

Best regards

Alfred


Diosna sampling points.zip (740.2 KB)

Dear Sims,

As the sampling location can be decided based on following factor

  1. These are decided by both production and validation tem based on their experince.
  2. Operator who actully do the cleaning for that particular equipment because he was the person who exactly know the location which is hard to clean.

One more thing is very importtant you should give some rationale, why this particular locations are hard to clean??

For Rapid Mixer Granulator - Agitator, discharge valve and side valve of RMG are the sampling location

Regards

Prashant Mhetre