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Rubber stopper is a primary packaging material for large volume parenteral. Hence, usage of different types of rubber stoppers is very common for the sterile pharmaceutical industry. However, sterilization validation of different rubber stopper is a very difficult and time consuming job. Hence, scientific rationale to develop a common sterilization process for the different rubber stoppers loads by validating minimum number loads having great business
impact. 13 mm plain, 13 mm slotted, 20mm plain, 20 mm slotted, and 28 mm slotted rubber stopper with their maximum and minimum loads used for the study. Normally three successful
sterilization cycles required for each type minimum or maximum load qualification. This study is to identify the worst case load/loads with scientific rationale and validate the same to assure a single sterilization process for all type of rubber stoppers loads
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