PURPOSE: 

To lay down  the procedure for destroying the rejected vials and ampoules.

SCOPE: 

This procedure applies for all types rejected vials and ampoules

 RESPONSIBILITY :                                    

1. Production Manager          

PROCEDURE:

Filled glass vials and ampoules which ‘are rejects need to be periodically destroyed under proper supervision using the standard procedure.

PROCEDURE FOR VIALS

1 Obtain the necessary authorization for destruction where ever applicable.

2. Check the labels on the bulk containers holding the vials to be destroyed.

3. If the vials to be destroyed are individually labelled and packed, then de-pack the vials from the shippers and de-label these vials by soaking them in a tub containing water and remove the labels.

1. De-Seal each individual vial using a de-sealer ,and remove the stopp’er from each vial.
2.  Collect the contents of each vial in a suitable container by emptying each vial.
3.  Discard the collected contents into a drain after diluting the collected contents with water.
4. Consign the recovered stoppers and seals to scrap.
5. Crush the empty vials.
6. Prepare the Destruction Certificate mentioning the product, batch number, quantity destroyed and reason for destroying.

PROCEDURE FOR AMPOULES

1..Obtain the necessary authorization for destruction where ever applicable.

2. Check the labels on the bulk containers holding the ampoules to be destroyed.

3 .If the ampoules to be destroyed are individually labelled and packed, then de-pack the . ampoules from the shipper and de-label these ampoules by soaking them in a tub containing  water and then removing the labels.

4. Open each ampoule by breaking at the neck.

 5.Collect the content of each ampoule in a suitable container by emptying each ampoule.

 6. Discard the collected contents into a drain after diluting the collected contents with water.

7. Crush the empty ampoules.

 8. Prepare the destruction certificate mentioning the product, batch number, quantity destroyed and reason for destroying.

(Review date on or before 12 months from date of authorization)