Buffer Formulation Vent Filter Re-Use at Parenteral Manufacturing Plant

Abstract

For sterilization-in-place cycles that used vent filters as a redundant non-contact product, the filter membranes could be re-used several times without impacting their integrity neither compromising the sterilization cycle. At a parenteral manufacturing plant in Puerto Rico, the vent filter is discarded after exposed to a one-single sterilization-in-place cycle. With the implementation of this project, the vent filter used during the sterilization-in-place as part of the buffer formulation at Manufacturing Plant can be re-used up to 50 times. With DMAIC (Define, Measure, Analysis, Improve and Control) quality strategy, the use of vent filters during buffer formulation at Manufacturing Plant was improved. Under DMAIC, the sterilization conditions of the filter’s manufacturers was identified as the worstcase sterilization scenario. Also, validation activities were executed to confirm no moisture residual particles were found in the vent filter membrane after multiples consecutives sterilization cycles. At the end, this project implementation will provide better manufacturing flexibility and costsavings for up to USD 105,000 yearly. Key Terms ⎯ reuse filter, steaming, sterilization-in-place, vent filter