Quality
Quality is at the heart of everything we do.
All Innovative Laboratory Products (ILP) parts are made utilizing clean techniques and state of the art manufacturing processes. Each lot of product produced is held to our strict quality standards and tested for RNase, DNase, Extractables, and endotoxin (Pyrogen) contamination. Parts are regularly inspected for visual, dimensional, and functional attributes. Pre-sterilized products comply with ANSI/AAMI/ISO 11137 and must be certified to have a SAL of 10-6. We offer to our customers lot-specific Certificates of Compliance upon request, or directly from our website .
Rigorous Quality Control
All manufacturing lots are sampled and tested for the following characteristics in accordance with Standard Operating Procedures prior to release.
- Visual Attributes Pass (all physical attributes are within tolerances)
Dimensional Attributes Pass (all dimensions are within tolerances) - Functional Tests Pass (where applicable – Tip Warp, Leak Test, Centrifuge Force, Cap Closure Force)
- Sterile Products (applies only to sterilized items): Sterile catalog numbers from this lot have been pre-sterilized and dosimetrically released based on ANSI/AAMI/ISO 11137 sterilization of healthcare products requirements for validation and routine control radiation sterilization. Sterility Assurance Level: SAL 10-6.
- Endotoxin (pyrogen) Testing: Products are directly tested for endotoxins by the Limulus Amoebecyte Lysate (LAL) gel clot assay according to USP/FDA guidelines for medical devices or PCR. Acceptable levels of LAL: undetectable levels of endotoxin at 0.05 EU/mL, or PCR: <10 amplifiable targets.
RNase/ DNase/ DNA Testing
Testing is by electrophoresis. Test sensitivity: RNase – 10-9 Kunitz Units/ ul; DNase – 10-6 Kunitz Units/ ul; DNA – 30pg. Product must be free of detectable contamination.
Have a lot number and need a Certificate of Compliance?
Click here.
ILP products are designed for laboratory use and are not suitable for food or in-vitro diagnostics.
Have a lot number and need a Certificate of Compliance?
Click here.
ILP products are designed for laboratory use and are not suitable for food or in-vitro diagnostics.
