Sanitization validity study of Hopper used for holding container, closure

Validation
1

How one can conduct Santitization validity study of hopper for holding container and closure - filling machine in sterile filling line?

Thanks

2

Hi, since those hoppers are in contact with items that are in direct contact with the product; the requirement is to sterilize them, not just sanitize them, unless the product is subject to a validated terminal sterilization.

Almost every filling machine intended for filling sterile products are designed so that it is able to dismount pieces, like hoppers, for sterilization within a steam autoclave. This is a typical URS verified during the IQ of the equipment.

So, if you follow this path, you wwould have to validate the sterilization process as dictated by the regulatory frame applicable to your process/product.

Hope this helps.

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