The Challenge
Sefar AG manufactures high-precision implant components from medical fabrics. A critical bottleneck was the lack of reproducibility when applying holes in the fabric with existing needle plotters. Additionally, the fragile nature of the fabric prevented automated handling.
Identified Pain Points & Risks:
- Quality Defects: The existing needle plotters could not ensure the required accuracy of holes in a process-reliable manner
- Handling Barrier: Without mechanical stabilization, the extremely fine fabric was not manageable for standard industrial robots
- Process Uncertainty: Lack of statistical data about the manual process complicated targeted optimization of parameters
- Compliance Requirements: As a manufacturer of Class III implants, Sefar required a fully validatable solution according to GAMP 5
- Cost Risk: Every reject due to hole defects caused significant material costs with the high-quality medical fabrics
The consequence: Quality fluctuations, high rejection rates, and lack of scalability. A reproducible, automated solution was urgently required.
Our Solution
Pharmabotix transformed the process through in-depth engineering and statistical validation into a high-precision automation solution.
System Architecture & Components:
- Pharmabotix Needle Plotters: Two newly developed plotters based on Jenny Science linear axes replace the unstable legacy systems. The high-precision linear guides guarantee reproducible hole positions with minimal deviation
- Siemens Technology Kinematics: The highly complex movement sequences of the plotters are mapped as integrated kinematics directly in the Siemens technology control. This enables seamless integration into the overall system and precise synchronization
- Ultrasonic Punch: Precise punching of final contours from the processed fabric. Ultrasonic technology minimizes mechanical stress and guarantees clean cut edges
- Special Clamping Frame: Development of a standard fixture that fixes the fabric and thus enables safe, robot-assisted handling. The clamping frame stabilizes the fragile material without damaging it
Technology Highlights:
- Process Optimization Through Data: Pharmabotix analyzed over 1,000 data sets from statistical measurement series to define ideal parameters for the fabric. This data-driven optimization led to a significant reduction in rejection rate
- Highest Precision: The redevelopment of the needle plotters finally solved the problem of lack of reproducibility in holes. Each hole is placed with micrometer-accurate tolerances
- Vacuum Robotics: A robot handles the transport of fabric parts fixed in the clamping frame between process stations using vacuum grippers. This eliminates manual handling and reduces contamination risks
- Data Sovereignty: All relevant parameters such as plotter images and punch specifications are stored directly in the Siemens HMI and protected in the audit trail. This guarantees complete traceability and compliance
GAMP 5 Qualification:
- Complete qualification according to GAMP 5 for manufacturing of Class III implants
- Validated process parameters with statistical process control (SPC)
- Complete documentation of all process steps for regulatory audits
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