Ralf Schiessl

Technical

Reevaluating Transfer of RTU Containers Into Grade A

1 January 2025

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.

Features

Air Speed Qualification: At Working Position or Working Level?

1 September 2023

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...