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Hello!
Thank you very much guys. This forum is very helpfull for us, I really appreciate your help!
I'm still in dilemma. First I wanted to tell you that the instructions from our boss are to change the parameters (We are decresing the forming time in order to have more products packed per minute) and report this as verifications and to perform tests on EMPTY packages, without any product inside!
I really can not find any logic in this. Isn't the point of making all the tests when changing the parametes proving the sterility of the product after sterilization, not the sterility of the package or the sealing of the package because of itself??!
Thank you very much guys. This forum is very helpfull for us, I really appreciate your help!
I'm still in dilemma. First I wanted to tell you that the instructions from our boss are to change the parameters (We are decresing the forming time in order to have more products packed per minute) and report this as verifications and to perform tests on EMPTY packages, without any product inside!
I really can not find any logic in this. Isn't the point of making all the tests when changing the parametes proving the sterility of the product after sterilization, not the sterility of the package or the sealing of the package because of itself??!