Manufacturing Excellence

Present R&G BIO’s integrated manufacturing capabilities for medical‑grade tattoo needles, PMU cartridges and consumables, highlighting cleanroom production, automated lines, ISO‑level quality control, and OEM/ODM readiness.

At R&G BioTech Medical, manufacturing isn’t just about making products – it’s about creating medical-grade solutions that practitioners trust and clients depend on. Our 23,0201m² facility operates at the highest global standards, ensuring every device meets pharmaceutical-level quality controls.

ISO Class 7 Cleanroom Environment

Pharmaceutical-grade contamination control

Our cleanroom facility maintains ISO Class 7 (Class 100,000) standards, the same level required for pharmaceutical manufacturing. This means fewer than 10,000 particles (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 state-of-the-art automated production systems ensure every device is manufactured to exact specifications with zero human error variance. Computer-controlled precision meets medical-grade consistency.

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 isn’t checked – it’s built into every stage of production. Our multi-point inspection protocol ensures that only perfect products reach our clients.

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 industry standard. Every batch is traceable to 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

What Medical-Grade Means for You

Translating manufacturing excellence into real-world benefits

For Practitioners

  • Consistent, predictable results every time
  • Zero contamination risk
  • Complete regulatory documentation
  • Professional liability protection

For Clients

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

For Brands

  • Premium positioning in market
  • Regulatory compliance simplified
  • Customer trust and retention
  • Competitive differentiation

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?

Request detailed manufacturing documentation, facility tour information, or discuss your specific requirements with our team.

Request Manufacturing Details