In the first part of this series, we examined the current state of material transfer across cleanroom grades in pharmaceutical manufacturing. Despite rapid advances in automation, the transition between zones of different GMP classifications remains heavily dependent on manual decontamination processes.
This blog post produced by the ISPE D/A/CH CoP Aseptic Processing – Subgroup Appropriate Technologies, synthesizes regulatory drivers from EU/PIC/S GMP Annex 1 and provides guiding principles for installing sterile format parts into open isolators, presenting stepwise transfer and handling strategies to protect critical surfaces, first air and to ensure product sterility.
At first glance, ready-to-use (RTU) primary packaging material (tub systems) give production lines more flexibility and reduce container preparation complexity for aseptic fill/finish operations. However, the aseptic introduction of RTU tub systems requires a thoroughly designed transfer process to avoid contamination of the sterile RTU items and the aseptic core.
