Industry Experts Combine to Create Safer Intravenous Delivery
25 February 2019
February 25, 2019 Rome, Italy – The Italian Biochemical Institute (IBI) "Lorenzini", Comecer, and Particle Measuring Systems (PMS) recently partnered to leverage and combine the expertise of each entity to design a new drug delivery system and a filling line to safely and effectively manufacture it. A Quality Risk Management (QRM) approach was used as the basis to meet the distinctive needs of the aseptic filling line and ensure that regulatory needs were met.
This partnership started when IBI designed a new approach to drug infusions deliveries, patented as “Espresso®”. “Espresso was created to ensure the safe delivery of sterile intravenous medication to patients”, said J. Khevenhüller, CEO at The Italian Biochemical Institute (IBI). “Following the initial project, we needed a way to safely mass produce Espresso. However, because of its unique design, existing filling lines could not meet our needs, so we contacted Comecer to create something new.”
“When Lorenzini approached us with their Espresso approach, we were immediately intrigued by the design challenges it presented. We took on the project to create something with a completely fresh approach to ensure the product sterility”, said S. Penazzi, Sales Area Manager Pharma Division at Comecer. “We had worked with PMS in the past and invited them to join our development team to leverage their industry knowledge.”
“Our Advisory Team has experience working with manufacturers to ensure they meet regulatory needs and to provide safe drugs to their customers, and we were confident our background could help solve the needs of the Espresso approach”, said Maurizio Della Pietra, Global Data Management Specialist and Process Advisor at Particle Measuring Systems. He continued, “Our insights to regulatory requirements, plus Comecer’s expertise in building filling lines, combined to create a forward-thinking, effective result.”
“As aseptic manufacturers develop unique new solutions, the requirement for increasingly complex manufacturing requirements to meet quality standards and to ensure the safety of drugs arises”, said Gianni Scialo, VP Pharmaceutical, Particle Measuring Systems. He continued, “Creative partnerships such as that between IBI, Comecer, and PMS will become increasingly important to meet these needs."
About Particle Measuring Systems
Particle Measuring Systems Inc. (PMS), a subsidiary of Spectris plc, is a global technology leader and expert in contamination monitoring, the inventor of laser particle counting, and now is the leading provider of solutions for monitoring and controlling many forms of contamination that impact companies that manufacture in ultra-clean environments. For more information visit pmeasuring.com
Comecer develops and manufactures high-tech systems in the field of Aseptic Processing and Containment for the Pharmaceutical and Nuclear Medicine Industries, specialising in isolation technology solutions for regenerative medicine and tissue engineering.
We aim to contribute to progress and preserve life through the development of highly innovative technologies and sustainable solutions, according to the latest GMP (Good Manufacturing Practice) regulations. Learn more at www.comecer.com
About The Italian Biochemical Institute (IBI) "Lorenzini"
IBI, IBIGEN group, is a company that has been producing and selling injectable products all over the world for 100 years. It is also present in hospitals (Parental Products for Hospitals). Expert in aseptic dosing and ß-lactam products, it is a vertically integrated company working from the raw material through the finished product to sales distribution and the patient’s bed. Learn more at www.ibi-lorenzini.it
Particle Measuring Systems
Boulder, CO 80301
IBI Biochemical Institute
T: +39 06 921501
T: +39 0546 656375