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.
The new European Commission GMP Annex 1 “Manufacture of Sterile Medicinal Products” and the equivalent Annex 2 from the World Health Organization (WHO) triggered a discussion in ISPE’s Germany/Austria/Switzerland (D/A/CH) Aseptic Processing Community of Practice (CoP) Steering Committee about where to qualify air speed: “at working position” versus “at working level.” This article provides...
