Assessing contamination control of pre-sterilised container tub transfers into an aseptic manufacturing filling isolator via a de-bagging/no-touch-transfer process step

Artikel i vetenskaplig tidskrift, 2016

Experimental contamination transfer challenge studies were designed to assess whether contamination control and sterility are maintained when using a no-touch-transfer (NTT) de-bagging tub transfer method to introduce pre-sterilised containers into a FlexPro50 aseptic manufacturing isolator/restricted-access barrier system filling line system. Importantly, the sterile tubs of product containers are enclosed in double steri-bags, and remain sterile through the supply chain to point of filling. Use of NTT means that any of the current automated bio-decontamination steps usually employed prior to material transfer into Grade A areas are rendered unnecessary; since the bag contents remain sterile and protected and can be transferred without exposing the Grade A aseptic processing zone to the outer bag. To support this rationale, two key contamination control studies were undertaken during processing of tub transfers with the NTT/de-bagging technology; 1)surface-to-surface transfer of human commensal microorganisms representing the challenge of "worst case" operator handling, and 2) a structured approach evaluating the risk of airborne contamination as tubs move through the NTT process steps into the Grade A isolator environment by a particle challenge method (limitation of risks method). In these studies, the barrier-isolator environment remained robust to adverse particle movement, without microbial contamination transfer. In addition, the sterile tub outer surfaces were confirmed as maintaining sterility during the NTT process step. These results provide proof of concept of NTT technology.