Your Contract Development and Manufacturing partner
Individual plastic solutions for the pharma, diagnostic and medical market.
At Balda, our experts are specialists in multi-component injection molding and automated system assembly. As a one-stop solution provider and manufacturer, we can cover all parts of the process, from product development to delivery of the final product, packaged and sterilized as needed.
Established player in the market
With over 110 years of company history, we have unique knowledge of large-scale
manufacturing of plastic components as well as complex assembly. As a producer, we combine
the highest quality standards and economies of scale like no other company, for large volumes and
high product complexity.
Flexible CDMO approach
Thanks to our integrated approach, we can harmonize all the different development processes from the definition phase to the production and global supply of your products. You can count on decades of experience in development and industrialization of complex systems.
Modular processes allow customers to enter at different project stages, according to their needs and requirements.
More information on our services in all three market segments
Competences in Plastic Solutions
Product Development & Engineering
- Development of ideas using systematic and product-oriented development approaches
- Definition and documentation of product requirements
- Development of concepts and mock-ups, based on proven manufacturing knowledge and experience
- Detail development of the chosen concept
- Documentation according to DHF and DMF
- Mechanical and functional testing, risk management, usability studies, verification
- Product development in collaboration with proven partners in drug delivery devices
- Market driven in-house development
Intellectual property
- IP product portfolio
- Long-term strategy for in-licensing agreements with established partners
Process Development
- Planning of the entire production process based on top-level engineering capabilities
- Requirement-based development from manual to fully automated assembly and ancillary processes
- Selection of machines and tooling based on long term collaboration with renown manufacturers
- Low & high cavitation molds from leading tool suppliers
- Durable equipment to ensure highest process reliability
Production
- 16,900sqm of controlled & cleanroom areas (GMP, class ISO 8 and ISO 7) in Germany and the US
- 160+ High-precision injection molding machines available at our sites in the US and Germany
- Possibility of up to 128 cavities, clamping force 20t – 500t
- 40+ Assembly installations from manual to full automation
- 24/7 production from small scale to mass production
- Manufacturing know-how and proven production experience in mechanics and electronics
- Product-specific in-line inspection
- In-house Repair & Maintenance (including preventive mold maintenance)
- Individual tool maintenance strategies with spare parts availability to ensure production continuity
Final Assembly, Labelling & Packaging
- Fully automated flexible, scalable and modular assembly for multiple components and linked processes
- Finishing technologies for decorated and functionalized surfaces
- Integrated, tailormade packaging and labelling
Quality
- ISO 15378 & ISO 13485 certified Quality Management System compliant with 21 CFR Part 820 in the US facilities
- Six-Sigma approach throughout the entire industrial product life cycle
- Risk-based qualification and validation (DQ, IQ, OQ, PQ)
- Worldwide product registration experience
- Development of product-specific test methods using state-of-the-art measuring technologies of quality assurance
- Experience in product registration
- FDA audited site (Germany)
- State-of-the-art measuring technologies with computer tomography, tactile and optical measurements
Project Management
- Strong customer support throughout the whole product life cycle
- Phase and Serial Production
- Dedicated responsibility for the assurance of quality, time and cost within the industrialization process
- Accommodation of specific customer requirements such as biocompatibility, shipping validation or stability tests
Global supply chain
- Proven program management
- Transport validation
- Global purchasing network
- Global logistics expertise
- Europe
- Asia
- America
