DESTRUCTION OF REJECTED AMPOULES & VIALS

1. Objective:
To lay down a standard procedure for destruction of the rejected ampoules / vials.
2. Scope:
Filled glass vials and ampoules which are rejected need to be periodically destroyed under proper supervision using the standard procedure.
3. Responsibility:
¯ Operator.
¯ Production supervisor.
¯ Head - Production.
4. Procedure:
4.1. Obtain the necessary authorization for destruction where ever applicable.
4.2. Check the labels on the bulk containers holding the vials / ampoules to be destroyed.
4.3. If the vials / ampoules to be destroyed are individually labeled and packed, then de-pack the vials / ampoules from the shippers and de-label these vials / ampoules by soaking them in a tub containing water and remove the labels.
4.4. De-seal each individual vial using a de-sealer and remove the stopper from each vial / ampoule.
4.5. Collect the contents of each vial / ampoule in a suitable container by emptying each vial.
4.6. Discard the collected contents into a drain after diluting the collected contents with water.
4.7. Consign the recovered stoppers and seals to scrap.
4.8. Crush the empty vials/ampoules.
4.9. Prepare the destruction certificate mentioning the product, batch number, quantity destroyed and reason for destroying.
Note: All the above process carried out in presence of a trained staff