Manufacturing Excellence

Medical-grade tattoo needles, PMU cartridges, and consumables, made in our own cleanrooms on automated lines, with full OEM/ODM support.

At R&G Bio, manufacturing is not just about making products. It is about making tools that professionals can trust on their clients’ skin. Our facility runs to medical-device standards, so every batch gets the same level of control.

ISO Class 7 Cleanroom Environment

Pharmaceutical-grade contamination control

Our cleanroom holds ISO Class 7 (Class 100,000) standards, the same level used in pharmaceutical manufacturing. That means fewer than 10,000 particles of 0.5 microns or larger per cubic foot of air.

Key Cleanroom Features:

  • HEPA filtration with 99.99% particle capture efficiency
  • Positive pressure differential to prevent contamination
  • Temperature and humidity control within ±2°C and ±5% RH
  • Real-time particle counting and environmental monitoring
  • Gowning protocols equivalent to pharmaceutical standards

Automated Production Lines

Precision manufacturing at scale

Our automated lines build every device to the same spec, batch after batch. Computer-controlled processes take the human wobble out of the work, so the needle you get in June is the same as the one you got in January.

99.8%
Production Consistency
0.02%
Defect Rate
24/7
Production Capability
100%
Batch Traceability
tattoo needles production workshop

Strict Quality Control Process

100x microscopic inspection on every batch

Quality is not checked at the end. It is built into every step. Our multi-point inspection process means only products that pass every check reach you.

7-Stage QC Protocol:

1. Raw material verification and purity testing
2. In-process dimensional inspection
3. 100x microscopic examination
4. Sterility validation testing
5. Package integrity verification
6. Final batch release testing
7. Stability and shelf-life validation

Our Quality Promise:
Less than 0.02% defect rate, more than 50x better than the industry standard. Every batch is traceable to its raw material source, production date, operator, and equipment used.

Medical-Grade Raw Materials

Quality starts at the source

Stainless Steel Standards

  • Medical-grade 316L stainless steel
  • Certified biocompatibility (ISO 10993)
  • Mirror-finish surface (Ra < 0.2μm)
  • Traceable material certificates

Supplier Vetting

  • ISO 9001 certified suppliers only
  • Annual audits and performance reviews
  • Incoming material testing on every batch
  • Long-term supply agreements
Translating manufacturing excellence into real-world benefits

For Practitioners

For Clients

  • Maximum safety assurance
  • Optimal healing and results
    Minimal risk of complications
  • Confidence in treatment quality

For Brands

Medical-Grade vs Standard Manufacturing

Understanding the difference
Feature
Medical-Grade (R&G Bio)
Standard Manufacturing

ISO Class 7 Cleanroom

24/7 Environmental Monitoring

100% Sterility Testing

Automated Production Lines

Medical-Grade Raw Materials

Batch Traceability

CE/FDA Documentation

Microscopic Inspection

Ready to Experience Medical-Grade Manufacturing?

Need detailed manufacturing documentation, a facility tour, or want to talk through your requirements? Our team is happy to help.