Manufacturing Standards
Derma Pen Factory Quality Standards
TBPHP operates ISO Class 7 cleanroom production lines with documented assembly procedures, in-process inspection, final testing, and batch traceability. The site reports 47 inspection points and complete batch records for production review.
- ISO Class 7 cleanroom lines
- 47-point production records
- Incoming, in-process and final QC
- Batch traceability
Manufacturing Capabilities and Quality Control
TBPHP operates four automated production lines dedicated to microneedling cartridge assembly and packaging. Each line operates under controlled temperature (20-24C), humidity (45-65% RH), and positive pressure differential.
Production Equipment
- Four Engel injection molding machines with infrared cavity temperature control (32-cavity molds)
- EDM needle profiling stations with 3-axis precision (+/- 2 micron positioning)
- Automated needle-to-hub assembly fixtures (hardened tool steel, replaced every 50,000 cycles)
- Linear motor driver test stations (12-point force linearity verification per driver)
- Laser profilometer for needle exposure measurement (+/- 0.01mm accuracy)
- Scanning electron microscope for tip radius verification (1.5-3 micron target)
- Contact profilometer for surface roughness measurement (Ra below 0.15 microns)
Quality Control System
Every production batch is managed through our digital manufacturing execution system (MES) which tracks 47 parameters including: raw material lot numbers, machine parameters, operator IDs, in-process inspection results, and final QC data.
Statistical process control (SPC) is applied to 14 key parameters per batch: needle tip radius, exposure length, angle deviation, hub flash, seal strength, pull-off force, packaging integrity, and EO residual levels. Control limits are set at +/-3 sigma from historical mean.
Sterilization
EO sterilization is performed per ISO 11135 with full cycle validation for each cartridge configuration. Process challenge devices (PCDs) are placed inside the cartridge lumen and hub cavity during every validation cycle. Sterility assurance level: SAL 10^-6.
Residual EO testing per ISO 10993-7 is performed on every production batch before release.
Traceability
Unique lot numbers are assigned to every incoming raw material batch. The MES tracks material through needle grinding, assembly, sterilization, and final packaging. Complete batch records are retained for 10 years.