The third session of the Symposium focused on manufacturing and quality and issues related to the two fundamental aspects of pharmaceutical manufacturing: prevention of contamination and cross-contamination.
Alessandro Regola and Lino Pontello explained how to avoid the occurrence of these compromising eventualities in the drug manufacturing process. Innovation is the key word: innovation in procedures and innovation in production facilities.
Measures must be introduced to reduce the risk of contamination, especially for injectable drugs that have greater vulnerabilities, also following the new guidelines that Annex 1 has introduced. Dr. Pontello reminds us that the main source of risk and potential contamination is the operator himself, so good training and total sterility of the work environment are essential.
During the Symposium session, attention will be paid to what factors are most likely to affect the prevention of contamination and cross-contamination. Certainly the introduction of automated production processes will ensure levels of contamination prevention not otherwise achievable with traditional systems, totally eliminating the risk given to the operator himself.
One of the main pharmaceutical products to be subject to contamination is the biological drug, which is easily contaminated by viruses, and it is on this front that many innovative changes are taking place.
A hint also to the “clean by design” approach involving the validation of sterilization and quality control processes, which will also be covered at the Symposium: in fact, during the session there will be a moment dedicated to the so-called “cleanability” of pharmaceutical production equipment, a procedure that will be used to set parameters to be respected during the production stages. The introduction of a risk assessment will make it possible to maintain higher standards of cleanliness and sterilization.
All this, of course, with the greatest possible respect for the environment, which will be protected in the choice of chemicals for cleaning equipment.
