Case Study - Successful integration of XiltriX in the Erasmus MC ATMP Laboratory

Case Study – Successful integration of XiltriX in the Erasmus MC ATMP Laboratory

How to create & monitor the cleanest room in Rotterdam

Over the period of 2019 to 2021 the Erasmus MC in Rotterdam built and validated a new Advanced Therapy Medicinal Products (ATMP) Laboratory. This facility boasts 4 fully equipped clean rooms which are qualified for handling of ML-1 and ML-II level genetically modified organisms. The quality system used is GMP compliant, which means the lab has to prove it is continuously in control on all levels. Parts of this quality system is the monitoring of temperatures, CO₂, humidity, differential pressure and particle counting (Environmental Monitoring System). XiltriX was chosen as the system to provide the real-time monitoring and alarm services. (Source: https://www.erasmusmc.nl/en/research/facilities/atmp).

The Story of the Erasmus MC Pharmacy

The Pharmacy department of the Erasmus MC is one of the largest departments of the hospital, employing over 300 staff which work in different groups. Some groups work in the back office in medicine production and preparation, clinical trials and pharmacology- and toxicology lab. Others in the front office provide medications and handle logistic throughout the hospital. As a teaching hospital the
Pharmacy department also has an advanced training program.

In this case study, together Ms. Anouk van Dapperen, responsible for Quality Assurance, we dive deeper into the challenges encountered during the design and construction of this remarkable laboratory. We also look ahead at future steps in the continuous strive of the Erasmus MC Pharmacy to improve quality.