RT Journal Article
SR Electronic
T1 Validation and Control of Non-Standard Sterilization Processes
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 9
OP 15
VO 47
IS 1
YR 1993
UL http://journal.pda.org/content/47/1/9.abstract
AB With the upcoming abundance of sterilization techniques applied to various pharmaceutical product types, it has appeared useful to the committee to compile general guidelines for the proper mastery of this critical step of many pharmaceutical processes. Derived from the experience gained with conventional and more recent sterilization processes, this reports offers guidance for the definition of product sterility and the validation and control of the safety, reliability, efficiency, and proper operation of the non-standard sterilization processes.