Controlling contamination in environments where biological medicinal products are handled is of paramount importance to ensure the safety of personnel, sterility of drug products, and protection of the surrounding environment. The application of vaporized hydrogen peroxide (vH2O2) has emerged as a promising method for postproduction decontamination due to its ability to...
Krisha Patel is Co-Founder of Assurea LLC, a digital compliance consulting firm that provides IT and validation services, software assurance, and custom artificial intelligence solutions for biotech companies. With a degree in bioprocessing science and more than 12 years of experience in computer system validation and quality assurance, Patel has worked with cell and gene therapy companies,...
Massimiliano Cesarini, MEng, was named CEO of Biogenera SpA, Bologna, Italy in 2024. He began his career at Duferco Engineering in energy generation, then moved to Comecer Group, holding roles as project and product manager, and global sales manager for the pharma and advanced therapy medicinal product (ATMP) division. He eventually joined Omnia Technologies Group establishing the Omnia Life...
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Xuandai Hoang, Senior Member Services Coordinator in the Membership Department.
ISPE is an officially recognized stakeholder of the European Medicines Agency (EMA), the agency responsible for the monitoring of medicines in the European Union. One of the ways ISPE helps its members stay at the forefront of industry challenges and changes is by interacting with regulatory authorities in the countries our members represent.
Niranjan S. Kulkarni, PhD, was honored with the ISPE Max Seales Yonker Member of the Year Award at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, US.
The Dr. Antonio Moreira Memorial Professional Development Fund was established in 2024 in honor of Dr. Moreira, a former Chair of the ISPE Foundation Board of Directors who passed away that same year. As a 20-year member of ISPE, he was a dedicated leader who consistently championed the ISPE Foundation and tirelessly promoted the importance of student development and engagement.
ISPE’s Q12 Implementation Team continued its series of training events with a well-attended course for Singapore’s Health Sciences Authority (HSA) in November.
Effective containment systems in a pharmaceutical manufacturing facility are essential to protect the health of workers, the environment, and patients receiving the medications. Particles released into the facility can cause adverse side effects to facility employees, and particles released outside the facility can harm the atmosphere and nearby waterways.
