Which check point should I include in Standard Operating Procedure of Isolator (having Nutsche filter, dryer and micronizer) to ensure the leakages of hand gloves or integrity test?
2kg pressure of compressed air shall be applied to create positive pressure in chamber.
At this pressure gloves of isolater get swell up.
Now apply soap solution (teepol) on surface of gloves specially at joint .
If no air bubbles generate on gloves it means there is no leakage.
Thanks & regard
Thanks for your valuable reply…
The mentioned procedure is difficult to prove in audit ,I think pressure holding test for 900 second is good for isolator glove leak test
If u have glove leak test apparatus, u can use it. Attach the gloves with glove leak test apparatus and pressurize the gloves for specified time and follow the acceptance criteria as per sop.