Manufacturing Network Optimization
Ensuring Enhanced Assurance of Quality Supply
With market demand for single-use solutions growing at a double-digit rate, we have been continuously increasing our manufacturing footprint, with multiple sites and ISO 7 cleanrooms located on four continents. Secured supply is based on a region-for-region principle, keeping production as close as possible to end users’ locations.
- Global and optimized manufacturing network
- Multiple expansion programs have been executed in Yauco (Puerto Rico), Aubagne (France), Beijing (China), and M’Hamdia (Tunisia)
Building a Robust Supply Chain Based on Four Key Pillars
- Region for Region
Ensure market access
Increase speed to market
Decrease logistics efforts - Global Resilience
Ensure multiple sourcing where appropriate - Capacity Reserves
Ensure multiple sourcing where appropriate - Operational Excellence
Ensure multiple sourcing where appropriate
Reliable Partner
Secure Global Single-Use Supply From Research Through Clinical Phases to cGMP Commercial Manufacturing
Sartorius Enterprise Resource Planning (ERP): Our “Platform for Growth"
- Since 2013, Sartorius has successfully relied on an SAP ERP system operating within an efficient, worldwide template
- Harmonized and standardized core business processes across the entire Sartorius group ensure a high degree of process stability and a reduction of complexity
- Globally consistent first-class customer experience
- Supports organic growth while enabling faster integrations on a single integrated platform
Assurance of Quality Supply for Single-Use Solutions
Securing Single-Use Product Availability Resilience
To mitigate supply risks, our Assurance of Quality Supply (AoQS) is based on partnerships, quality agreements, and supply contracts with our suppliers to achieve tight specification and control of our resins, films, and components. The control of our entire supply chain and manufacturing process is the foundation for consistent quality, change control management, and business continuity planning.
We have been securing the availability of single-use products on the market, with extensive plans for increasing our manufacturing and sterilization capacities and the introduction of a multi-sourcing program.
The Challenge
Growing adoption of single-use solutions in all process steps of commercial production requires enhanced assurance of quality supply, global supply chain resilience.
The supply chain for single-use solutions is complex and can be impacted by several factors:
- Lack of transparency on supply chain and quality systems
- Variability of raw materials
- Demand doubling every 3–4 years with more complex designs
- Peaks of demand in case of pandemia
Our Solutions
Consistent quality | Robust supply chain management | Operational excellence | Business continuity
AoQS is built on 5 key pillars:
- Region for region: ensure market access Increase speed to market decrease logistics efforts
- Operational excellence: organization and discipline, strict implementation of safety, quality, lean basics
- Capacity reserves: enable fast ramp up to cover unexpected demand spikes
- Ensure multiple sourcing when appropriate
- Sustainability: decrease our environmental impact. Innovate and product in a sustainable way
AoQS Is Obtained Thanks to Partnerships With Critical Suppliers & Relies on the Full Control of Our Entire Supply Chain
- Material science, quality by design (QbD), film extrusion, bag making and product design expertise‘s are the foundations of AoQS
- AoQS is built on partnerships, supply contracts and quality agreements with our suppliers of raw materials, films and components
- AoQS agility with a multi-sourcing program providing higher business continuity assurance and better delivery services and lower lead times
- AoQS relies on the control of our entire supply chain & manufacturing process from the resins to the final single-use solution
Global Organization Excellence
Operational Excellence is Key
We have engaged in an extensive program for third party auditing allowing to ease the new manufacturing site acceptance
- Optimizing the audit process and efforts for both Sartorius and customers by replacing supplier audits by a paper audit package
- Partnering with recognized third-party auditing company Rx360 using relevant single-use reference/standard
Site Qualification Service
Sartorius has developed 3 levels of services to support adoption of new site or changes
- Rx-360 audit program
- 2 Site Qualification packages (standard and extended)
- Providing extensive site qualification packages options
Key benefits for:
Quality
- Audit and document referential adapted to industry
- 3rd party independent audit
- Consistency in documentation
Lead time
- Fast report /package availability
- Customer fast track qualification or minimum pre-qualification
- Optimized audit process (target audit Through Rx-360, resources both Customer/ Supplier)
Simpler, Safer, Faster & More Cost-Efficient Supply Chains for SUS
The adoption of SUS in all process steps & applications of commercial production drives the need for reducing complexity, enhancing quality, improving assurance of supply and reducing leadtimes.