rethink quality
Quality is a measure of precision. Scale is a measure of volume.
25,000 square feet of ISO and clean rooms (almost a million)
Our clean rooms are Class 10,000.Under 352,000 particles per cubic metre at 0.5 µm and larger.
- Reagent formulationand QCISO 7 Certified
- Volumetric aliquotingand QCISO 7 Certified
- Reagent packingand QCISO 7 Certified
- Lot release testingFinal QCISO Certified
- Product dispatchISO Certified
Forward by design
Quality control at every stage
Anybody can claim quality. We earned the credentials.
Specifications
Defined targets and requirements.
We’re not allowed to start from the catalog.
Design transfer
Risk assessment and verification.
We’re not allowed to change something quietly.
Manufacturing & release
Process controls and release testing.
We’re not allowed to release on one person’s say-so.
Distribution
Controlled storage and traceability.
We’re not allowed to lose track of a unit.
Technical support
Feedback review and quality investigations.
We’re not allowed to let a concern go quiet.
Controlled release
Products are reviewed against defined specifications and documented quality-control acceptance criteria.
Lot genealogy
Lot and batch records support traceability, with controlled CoAs, IFUs and SDSs provided as applicable.
Quality response
Feedback and quality concerns are assessed, investigated and followed up through the system.
Reduced lot-to-lot variability
Every lot is made and released against the same specifications, so a change in your results points to your biology, not to the reagent.
Most suppliers can’t publish this.We dedicated a page to it.
Certified by IAPMO SCB.