The USP <1207> provides guidance on the integrity assurance of nonporous packages intended to hold sterile pharmaceutical products. The documents provides background instruction about leak and how to test for leaktightness. The documents gives guidance about the evaluation of the Maximum Allowable Leakage Limit (MALL), this strongly depends on process, package, testing procedures and it is evaluated and determined by the user.
Furthermore the documents gives guidance about the validation and the method development.
