What is a servo press?

A servo press uses servo motors for precise force and position control during forming operations.

How do I calculate servo press tonnage?

Use our free tonnage calculator at servopress.club/tonnage-calculator.html

Servo Press for Medical Device Stamping: Validation and Process Control

admin

Medical device stamping on servo presses requires a higher level of process control and documentation than typical industrial applications. FDA 21 CFR Part 820 and ISO 13485 requirements drive specific practices.

## Why Servo Press for Medical Devices

Medical device components —surgical instrument blanks, implant components, catheter fittings —require:
- Dimensional tolerances of ?0.01-0.05mm
- 100% traceability of process parameters
- Validated and locked processes (no unauthorized changes)
- Statistical process control (SPC) data

Servo presses provide advantages over mechanical presses for these requirements:
- Programmable motion profiles allow precise control of forming speed and dwell
- Tonnage monitoring provides 100% in-process inspection
- Data logging capability for traceability
- Repeatable process from lot to lot

## Process Validation Requirements

Under IQ/OQ/PQ validation protocol:

**Installation Qualification (IQ):**
- Verify press specifications match purchase order
- Confirm calibration certificates for tonnage monitor and position encoder
- Document software version and parameter settings

**Operational Qualification (OQ):**
- Run press at 3 speed settings (min, nominal, max)
- Verify tonnage monitor accuracy against load cell reference
- Confirm position repeatability: ?0.01mm over 100 strokes

**Performance Qualification (PQ):**
- Run 3 production lots at nominal conditions
- Measure critical dimensions on 30 parts per lot
- Confirm Cpk —1.33 for all critical dimensions

## Data Logging Setup

Configure press data logging to capture per-stroke:
- Peak tonnage
- BDC position
- Forming speed at BDC
- Timestamp

Most modern servo presses support CSV export or OPC-UA connection to MES systems.

## Change Control

Any change to press parameters requires re-validation:
- Motion profile changes —OQ re-run
- Tooling changes —PQ re-run
- Press relocation —Full IQ/OQ/PQ

lisa_quality

FDA 21 CFR Part 820 requires documented evidence that the process consistently produces parts meeting specifications. The servo press force monitoring data is your best friend here. We archive every stroke's force curve for 7 years (FDA retention requirement). Storage is cheap —about 2KB per stroke, so a full year of production is under 50GB.

sarah_mfg_eng

The validation protocol for medical stamping on servo press should include: installation qualification (press meets specs), operational qualification (press performs correctly across the operating range), and performance qualification (1000+ consecutive parts meeting all specs). We budget 2 weeks for the full IQ/OQ/PQ cycle on a new die.