SOP For validation of washed vials (used for injection manufacturing) is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE

This procedure has been established to provide the guidelines to ensure the proper washing of vials.

SCOPE

This procedure is applicable to the Quality Assurance Department / Microbiology laboratory of Quality Control Department.

RESPONSIBILTY 

Q.A Officer

ACCOUNTABILITY

Manager Quality Assurance

PROCEDURE

Prepare 2.5% w/v solution of NaCl by adding 10 gm. of NaCl AR Grade in 400ml of water for injection. (WFI).

Dose each vial/ampoule with 1ml of NaCl solution, coat the bottom and sides of the containers by rotating the vial.

Dry the container in upright position at 50ºC (usually 18 – 24hrs).

Retain a minimum of 4 containers for positive control and 4 untreated containers as negative control. 

Wash the containers in specified washing area NLT 20psi pressure and  70otemperature.

Fill each container with WFI to approximately 50% of its brimful capacity (WFI must be free of chlorides).

Test for chlorides.

Perform the same test for unwashed containers as positive and unchallenged negative control.

Conclusion / Interpretation

Positive control of vial should show presence of chloride traces.

Negative control of vial should free of chloride traces.

All washed vial must free of chlorides traces.