Unknown material for swab sampling - Help!

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Hi everyone!

I have an unknown material on a tablet press that I would like to swab in cleaning validation studies. However, since I don’t know what it is (the company -Manesty- does not exist anymore and I is impossible to get a material certificate), I can’t do recovery study on this material.

Currently, we only assess this part visually. But I need more than that. What are my options?

  1. Execute the recovery test on the piece itself : difficult since the equipment is used often.
  2. Is is possible to test the material by any mean to find what it is? Maybe a company can do this test?
  3. I can’t replace this part by a new one.

Please can anyone tell me what is acceptable in this condition.

Thank you in advance for any of your help!

Caroline

2

Dear CSP,

Generally, all the product contact surfaces should be made-up of SS316 L (or brass in compression machine)
Or, your engineering department may identify the material types.

Finally, if you dont have any option, conduct the recovery studies on your piece itself.
though your equipment being used frequently, you need to prove its cleanability. So, you have to conduct it

Regards
VEERRAJU