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Reliable Production That’s Ready to Scale
Sanner’s global manufacturing network supports seamless transitions from pilot builds to full-scale production. We specialize in scaling high-quality, compliant processes for complex combination products and high-volume medical devices. Our focus on technical execution and control helps avoid production delays, material issues, or compliance gaps.
Key elements of our scale-up approach include:
- Modular cleanrooms across three continents
- High-precision injection molding and advanced automation
- Early application of Design for Manufacturing and Assembly (DfMA)
- End-to-end integration of design, engineering, manufacturing, and packaging to accelerate scale-up and improve control.
A Footprint Designed for Global Launches - Global Manufacturing Capacity
Sanner’s global manufacturing network spans Europe, Asia, and the U.S., with extensive production space and advanced cleanrooms supporting high-volume medical device manufacturing, including injection molding, assembly, and packaging. Each location is designed to support regional access and global production capacity. This scale and structure allow us to support high-volume manufacturing while adapting to customer-specific needs.
We offer:
- 28,500 sqm total production space
- 11,000 sqm ISO Class 7 and 8 cleanrooms
- Modular bays for molding and assembly
- Expansion zones for future cleanroom and equipment installation
- Consistent quality across sites
- Infrastructure that adapts to evolving customer needs
- Global capacity that enables regional launches with minimal transfer time
Greensboro/US
Bensheim/DE
Pittsboro/US – Tijuana/MX
Kunshan I/CN
Kunshan II/CN
Budapest/HU – Kirchheim/FR
Integrated, High-Precision Manufacturing
Our end-to-end services are structured for repeatability, compliance, and technical depth.
Medical Injection Molding
- Multi-shot molding options
- High-cavitation tools, supported by a trusted network of specialist partners
- Optimized for performance, cost-efficiency, and material flow
- Built for stringent pharma and MedTech standards
Manual or Fully Automated Assembly
- Assembly methods are matched to device complexity, volume, and production needs, ranging from manual and semi-automated to fully automated.
- We provide assembly for drug delivery systems, diagnostics, electromechanical and mechatronic devices such as dry powder inhalers, auto-injectors, prefilled syringes, and multi-component systems with embedded electronics and firmware.
- Our capabilities support both clinical builds and large-scale production. Processes include ultrasonic welding, RF and solvent bonding, gluing, and catheter tip forming.
- Assembly can be performed in ISO Class 7 and 8 cleanrooms with in-line quality testing, in-process controls, and traceable documentation to meet global regulatory standards, including ISO 13485.
Automation and Material Flow
To ensure efficient, reliable production at scale, Sanner’s manufacturing plants are equipped with state-of-the-art automation and optimized material flow systems, keeping production moving smoothly and supporting consistent product quality.
- Automated Guided Vehicles (AGV) move materials throughout the facility
- MES integration provides real-time tracking and control
- Automated climate-controlled warehouses
Kitting and Packaging
Our comprehensive kitting and packaging approach is built to maintain product integrity and meet the specific needs of pharmaceutical and medical device manufacturing, protecting sensitive products throughout their lifecycle and supporting safe, efficient delivery.
- Temperature-controlled systems for cold chain products
- Tailored kitting solutions for both drug and device requirements
- Integrated desiccant technology for moisture-sensitive products
Comprehensive Validation with Global Standards
Every project is structured around a documented, inspection-ready framework.
Validation Stages:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Compliance Standards:
- ISO 13485
- FDA 21 CFR Parts 211 and 820
- MDR 2017/745
- Applicable cGMP requirements
Systems & Controls:
- Product Lifecycle Management (PLM) system for documentation and audit readiness
- Integrated QMS with traceability, process control, and final testing
- Risk management protocols applied early and consistently
Digital Simulation & Design for Scale - Smart Manufacturing Begins with Smart Planning
We apply Virtual Reality (VR) simulation during layout planning and early-stage development. Design for Assembly is embedded into our process from the start, improving manufacturability and accelerating commercial launch timelines
Benefits include:
- Faster proof-of-principle studies
- Better production flow insights
- Reduced implementation risk
- Seamless handoff to high-volume production
Sustainability in Production - Climate-Responsible, Operationally Sound
Sustainability is a core principle at Sanner. We use EcoDesign and Life Cycle Analysis (LCA) to inform sustainable design and packaging decisions throughout scale-up and commercial manufacturing. We achieved an EcoVadis bronze ranking for Sanner Group, reflecting ongoing efforts to integrate sustainable practices that lower our environmental impact and reduce regulatory and operational risk.
Trusted by Leading Pharma and Medtech Companies Worldwide
- 130+ years of manufacturing and tooling experience.
- ISO 13485, ISO 9001, and ISO 15378 certified; fully GMP (FDA) and MDR-compliant manufacturing across Europe, Asia, and the U.S.
- Experienced DfMA and design transfer capabilities that help reduce risk and support efficient transitions from development to commercial manufacturing.
- Modern, fully automated production with 100% traceability, automated in-process controls, and real-world VR simulation for assembly and process optimization.
- Integrated desiccant technology for moisture-sensitive devices, an industry-leading capability unique to Sanner.
Ready to move from pilot to production?
Sanner delivers commercial manufacturing built to scale, globally aligned, and technically sound.
Learn more about Sanner’s integrated Design Transfer Process
