The medical, pharmaceutical, and biopharmaceutical industries are characterized by stringent quality, regulatory, and process requirements, particularly for high-mix, low-volume, high-complexity products. In this sector, compliance with documentation and standards is only the baseline — customers expect consistent quality, full traceability, and complete process control at every stage of production.
Addit Sp. z o.o. operates in this sector as a one-stop-shop supplier, delivering system solutions, integrated modules, precision frames, and complex components manufactured through precision sheet metal processing. Our competencies and processes have been developed specifically to meet the needs of OEMs in the medical and life science sectors, where critical factors include surface parameter control, weld quality, tight tolerances, certified materials, and comprehensive quality documentation.
Below is an overview of the key requirements that define our customers’ products and expectations — requirements that are an integral part of every project we deliver.
Medical, Pharmaceutical, and Biopharmaceutical Industry Requirements Addressed by Addit:
Traceability and Materials
- Full material and product traceability at every stage of the process
- Material restamping with maintained traceability continuity
- Material certificates compliant with customer and industry standards
- Certifications for materials and special processes
- Dedicated, certified suppliers qualified according to strict quality requirements
Quality and Process Management
- APQP elements applied during production launch and validation
- Statistical Process Control (SPC)
- Quality documentation based on applicable standards and customer specifications
- Consistent quality independent of production batch size
Surface and Visual Requirements
- Elevated visual standards for functional and visible components
- Increased cleanliness requirements for delivered parts
- Aseptic surfaces suitable for medical and pharmaceutical applications
- Surfaces resistant to aggressive cleaning agents
- Surface roughness below Ra 0.8
- Full surface parameter control across the entire product, including roughness and grinding quality
Welding and Leak-Tightness
- Tight geometric tolerances after welding processes
- Visual weld inspection under magnification — pores, discontinuities, and leaks are unacceptable
- Full leak-tightness required
- Ensuring patient safety
Added Value Delivered to Medical, Pharmaceutical, and Biopharmaceutical Customers
- Engineering and co-development
- Technical consulting
- Prototyping
- Full supply chain management, including dedicated suppliers
- Complete project documentation handling, including material certificates and approvals
- 100% material and process traceability
- Scalable serial production for precision sheet metal components, profiles, and machined parts
- Reduced deformation and improved weld quality through laser welding
- CL1 welding for safety-critical components
- Surface treatments including powder coating, directional grinding, abrasive blasting, passivation, and electropolishing
- Electrochemical marking of product identifiers and customer logos
- Assembly in full ESD protection
- Assembly and packaging in a cleanroom environment
- Testing according to procedures agreed upon with the customer
- Ensuring the expected quality level for every delivery
- On-time delivery according to the customer’s schedule
Solutions and Product Types We Deliver
- Bioreactors
- Vaccine production line modules
- Control cabinets
- Enclosures protecting sensitive electronics
- Leak-tight, multi-jacket, insulated stainless steel tanks
- Integrated modules, housings, and components for automated pharmacy systems
- Frames, modules, and components for operating and treatment tables
- Modules and components for tablet production equipment
- Modules and components for pharmaceutical packaging equipment
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