Requirement to cover cap vibration bowl

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Morning,
I am looking for a little assistance–A new capping machine has been installed with a vibratory bowl and chute. It places caps on a plastic bottle (filled with powder). Are we obliged to have a cover on the bowl? At the moment it is open. what is the guiding regulation?
thanks in advance. NK

2

Is your area Grade A,B, C? Are you worried about cross contamination or proliferation of the product? Is the capping machine in an isolator, or RABs? What is the personnel safety?

There probably won’t be regulations about this (I’m almost 100% sure there aren’t). This requires a discussion, engineering, and a risked based approach.

Good luck.

1 Like
3

Thanks for the reply. We manufacture for European market, so not sure about Grades. The fear is dust/particles landing on the cap. There is no operator risk, no particular safety gear needed for packaging operation. For liquid manufacture/packaging, all parts of equipment is covered, but just wondering about powder manufacture.

Thanks for help.

NK

4

If you cover for liquid, to keep dust out, then you likely would want to cover for powder to keep the dust out.