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Tracking Materials in Equipment for cGMP Compliance

A cGMP requirement of critical importance for pharma/biopharma manufacturers is knowing the contents in tanks and equipment at all times (21 CFR 211.105). Syncade provide the ability to track materials in equipment and log the materials to the electronic equipment use logs automatically in the Equipment Tracking (ET) module.  This provides increased visibility on the floor to operators and ensures that the contents of tanks, vessels, and other storage equipment are known at all times.   

Transferring material to equipment is performed as part of an ET event and a running total of the material added to the equipment is maintained as events are performed.  In the case of an existing material the event would be performed in conjunction with a material move.  In the case of a new material (for example created as part of the output from a process) the material could be maintained as WIP on the manufacturing floor and not added to inventory.  When materials are moved and created during recipe execution the material moves and equipment events would be executed automatically as they were performed or completed by the automation system.

When an event is completed there are four options to handle material transactions.

  • Record : Adds to the equipment’s current contents
  • Deplete:  subtracts from the equipment’s current contents
  • Clear:  prepares the equipment for a new contents
  • Do not record: no effect on the equipment contents.

Using material tracking in ET?  Share some of your applications and experiences

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