Quality You Can Trust.
Direct2Lab operates under ISO 9001 and ISO 13485 quality management systems with GMP-referenced manufacturing practices and a fully traceable verification framework. From raw material screening to automated manufacturing, QC testing, and application validation, we deliver consistent, audit-ready laboratory essentials trusted by research institutes, universities, biotechs, and global pharma teams.
Certifications & Quality Management System
- Manufacturing audited to ISO 9001 / ISO 13485
- Key processes aligned with GMP requirements
- Production lines validated by ISO/IEC 17025 accredited labs (e.g., SGS, TÜV)
- DNase/RNase-free, endotoxin testing per USP <85>, sterility per ISO 11137
- Full lot retention, COA documentation, and traceability suitable for audits
Product-Level Performance Validation
Our products undergo systematic performance validation through third-party laboratories and our in-house product innovation & quality lab:
- Pipette tips: accuracy/precision testing, low-retention, DNase/RNase-free, endotoxin-free
- Cell-culture plastics: sterility, biocompatibility (ISO 10993), surface uniformity
End-to-End Quality Control
We operate a full life-cycle QC framework covering raw materials, molding/formulation/assembly, finished goods, release, and application testing. The framework spans:
- Supplier qualification and raw-material screening
- Cleanroom manufacturing (Class 10,000)
- Automated and digital-twin production control
- In-process monitoring (temperature, metering, error correction)
- Finished-goods testing (sterility, endotoxin, inhibitor residues)
- Batch-to-batch consistency verification
- Lot traceability, retention samples, and documented release
