Industry 4.0 is a term which refers to the fourth industrial revolution and relates to a trend in manufacturing for automation, data gathering, interconnectivity between equipment, and includes cyber-physical systems, the Internet of things, cloud computing etc. Industry 4.0 is simply the next wave of operational excellence and SteriPack is positioning itself to have smart factories of the future, which will marry the old operational principles like Lean and six sigma with the digital trends of future manufacturing.
The beginning of this journey has been our investment in a Manufacturing Execution System (MES) which is an electronic system to execute, monitor, track and report operations on the plant floor in real time. MES is a critical component of Industry 4.0 that will act as an enabler to achieve an end-to-end digitisation objective, acting as a bridge between various plant floor systems and providing an integrated ecosystem for real-time information exchange and better, faster decisions.
SteriPack uses PAS-X software which is a market-leading system for discrete and continuous manufacturing in life science industries such as medical device, pharma and biotech. It is run by more than 50% of the world’s top 30 pharmaceutical and biotech companies and in approximately 800 installations around the globe. It is developed in strict accordance with legal requirements such as FDA 21 CFR Part 211 and Part 11, EU GMP and GAMP 5 guidelines.
- Quality by design
- Paperless production
- Electronic Batch Recording (EBR)
- Accelerated batch release times
- Shorter lead times
- Fast, reliable and secure data entry
- Efficient equipment management
- Improved process security
- Live monitoring of production
- High “Right First Time”
In conjunction with the MES implementation, our digital roadmap also includes positioning the company for complex automation projects with connectivity to our MES system and introducing serialisation and new label management processes. We are also investing in various different electronic management systems to strengthen and support business areas like CRM, SRM, Quality, Training and Business intelligence, to name but a few. Our long-term intention is to have the smartest of the smart factories of the future for medical device and pharmaceutical contract manufacturing. Four main objectives of MES are: