COMPLIANCE & REGULATION
Sterilization
- In-house gamma sterilization ensuring maximum sterility
- Validated as per ISO 11137/ISO 13004/11737:2 achieving SAL 10-6
- Customizable dose validation - VDmax 25 or tailored to your need
- Dose mapping for validating the uniformity and accuracy of radiation dose
Material Compliance
- Manufactured using US FDA Certified raw materials with global regulatory acceptability
- REACH & RoHS compliant: Free from hazardous substances
- Safe for sensitive processes: TSE/BSE free
- USP Class VI certified
Biological Safety
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Tested for Biological Reactivity
In Vitro: USP
In Vivo: USP - Achieving Endotoxin level 0.001 EU/ml: USP
- Microbial load validated with ISO 11737 bioburden testing
Chemical Compatibility
- Extractables and Leachables profile as per BPOG protocols and USP test standards
- Ensuring material stability for your most critical applications
Functional Validation
- Each product undergoes a three-step verification process
- Shelf-life tested for long-term integrity
- USP certified for particulate matter control
Dimensional Accuracy
- Tolerance and dimensions checked to match customer specifications
- BOM verification ensures complete traceability
- Every part, every detail double-checked before it reaches you
