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CAPPING MACHINE

Installation Qualification


The common requirements outlined in the "General" section are required. Additionally, product contact surfaces must be stainless steel or approved plastics or rubber.

Operational Qualification


In addition to the common requirements outlined in the "General" section, be sure to verify the missing stopper/no cap and missing bottle/ no cap interlocks.

Performance Qualification


Perform triplicate capping runs of all production bottle, vial and cap combinations. Do not run all vials of a single size sequentially. Exchange change parts and vary the vial size for each sequential run.

100% inspection of vials will be performed for visible defects and damage. Inspect for seals set square, an undamaged tuckunder, and that the seals are not marred or damaged. For each vial size capped, record the number of vials damaged and the number of vials capped incorrectly.

Performance Qualification Acceptance Criteria


Perform triplicate capping runs of all production vials Record the time to cap 100 vials. This is recorded as a baseline value

Do not run all vials of a single size sequentially. Exchange change parts and vary the vial size for each sequential run.

100% inspection of vials will be performed for visible defects and damage. For each vial size capped, record the number of vials damaged and the number of vials capped incorrectly. The damage rates are for baseline information, to form the basis of control parameters.