sterile package integrity

VALIDATION OF STERILE PACKAGE INTEGRITY

Package integrity is validated by sterility testing. At present there are no recognized methods for performing a whole package microbial challenge; therefore the package may be validated indirectly (e.g., using methods for detecting physical...

VALIDATION OF STERILE PACKAGE INTEGRITY 1

Package integrity is validated by sterility testing. At present there are no recognized methods for performing a whole package microbial challenge; therefore the package may be validated indirectly (e.g., using methods for detecting physical...

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