Benefitting from those lessons learned and preparing to implement new strategies for the future will be the focus of the ISPE Aseptic Conference.
The need to take advantage of new technologies and explore new ways for process control and efficiency permeates all areas of pharmaceutical manufacturing. Recent emerging technologies in aseptic processing such as advanced isolators, robotics, and increased automation have changed the industry and reduced contamination risks for sterile products. Simultaneously, modern therapies – new, targeted approaches to treatment resulting in small-batch aseptic products – are proving more difficult to sterilize and handle and requiring faster speeds to market. Furthermore, the updated Annex 1 will impact the manufacture of sterile products, setting new requirements for Quality Risk Management, Contamination Control Strategy, and Data Management and Compliance for Computerized Systems. The requirement to re-think the existing standards is becoming more urgent.
Come and meet the SKAN excellence team in Vienna at our booth.
Listen also to the presentation of
Theresa Ladwig (SKAN) and Thorsten Häfner (PSM)
“Validation of a fully gloveless aseptic isolator”
Aseptically processed biopharmaceuticals and emerging technologies create increasing demands on H2O2 decontamination cycle times, effectiveness and permitted H2O2 residual limits.
This presentation guides through the latest innovations in H2O2 decontamination solution with its advantages and meeting the latest cGMP and regulatory requirements i.e., Annex 1.
With the development of H2O2 decontamination cycles on a fully gloveless isolators new challenges will be discovered and according processes need to be established.
Furthermore, a process for cleaning and quantification of cleaning for a fully gloveless automated filling line needs to be established and validated.
Therefore, bullet points which needs to be covered for both validation steps will be:
– General aspects