Validation of Vial washing

Please find the attachment enclosed.


Vial washing.doc (116.0 KB)

good day durga,
i just want to know how should i test the chloride of the washed vials using water for injection. our vial washer is using the deionized water and then last rinse of water for injection, it has a built in stainless tube.after washing the vials with these deionized water and water for injection. what will i do next? do i have to fill the washed vials with water for injection just to see the particulate matter?is this what you mean?how should i check its greasiness?is there an equipment to monitor this or just feeling it?

regards,
nida

To test the chlorides you can rinse the sampled vials from washing machine and then rinse those with purified water and then carry out a limit test for chlorides in your lab.
You can carry out conductivity measurements from water from pooled vials.

To see greasyness and particulate matter you must carry out vial inspection on inspection machine witha magnifying glass or you can use an automatic inspection system. If you do not have both carry out a physical inspection on a black and white background on inspection table and it should be done with one who is having great expertise.

can you give me a sample sheet for the evaluation of result.


[COLOR=“blue”]NIDA P. SISON
ASHFORD [/color]

Report sheet attached


Vial washing validation report.doc (28.0 KB)