GMP and Occupational Requirements for Highly Potent Aseptic Processing

About the Educational Session:
Preventing Contamination and Cross Contamination in the manufacture of highly active or highly hazardous substances in the aseptic Processing will be the topic of the Webinar. In the Bio Pharmaceuticals production pipeline are many of those products in development or already in commercial manufacturing. Right now more than 1000 products in pre-clinical trials and clinical trials which are considered as high potent. Gen- and Cell Therapies “ATMPs Advanced Medicines of Medicinal Products”, ADC Antibody Drug Conjugates etc. All of them have the same challenge to protect the product aseptically to avoid particulate or microbiological contamination, protecting the operator and cleaning in shared equipment or/and rooms to prevent the risk of cross contamination. Especially where the aseptic fill & finish takes place are technical barriers like Isolators the first choice. How to design aseptic Isolators and what are the technical features to fulfil the GMP Requirements like for the new Draft Annex 1 will be covered. The topic of cleaning of nonproduct or indirect product contact within the critical zone of aseptic processing increased during the last few years since the Regulatory Guideline for setting health based exposure limits in shared facilities are published. During the Webinar this topic will be also covered and shows the recommended cleaning limits according to the PDE “Permitted Daily Exposure”.
About the Presenter
Richard Denk is working at the company SKAN AG, headquartered in Allschwil/Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard founded 12 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2015. Richard is also Chair of the ISPE Special Interest Group Robotic, Steering Committee Member of the CoP SPP Sterile Product Processing, Member of the ISPE European Leadership. Furthermore, member of the PDA Isolator Expert Group