Home/The QCRx®

Every IV bag verified before it reaches the patient. In under 70 seconds.

No dedicated laboratory No spectroscopy expertise Designed for BPP 2023
The QCRx® instrument
Compliant IV bagVerified in 68 s
What is the QCRx®?

An automated check, designed for the daily work of hospital pharmacies.

The QCRx® is not just a combination of spectrometers. It analyses 1 mL sampled from the finished IV bag by dual UV and Raman spectroscopy, compares the result with a library of validated references and gives an automatic verdict: compliant or non-compliant.

The QCRx® system and its sample changer
Quali · identity

It is the prescribed molecule.

The spectral fingerprint identifies the molecule: 5-FU, not carboplatin.

Quanti · concentration

The dose matches the prescription.

The actual concentration of the IV bag is measured and compared with the target.

Solvent · vehicle

The dilution solvent is the right one.

NaCl 0.9% or glucose 5%: the vehicle is verified with every analysis.

How it works

A sample goes in, a verdict comes out. Every IV bag, right in your hospital pharmacy.

Identification and assay

Two spectra, a single measurement: identity and dose, verified together.

1 mL sampled from the finished IV bag is enough.

QCRx® instrument
Spectra · IV bag #894021live
peak 1,002 cm⁻¹
UV, 200 to 400 nmRaman, 200 to 3,200 cm⁻¹
COMPLIANT
QUALIPaclitaxelscore 0.998
QUANTI0.60 mg/mLdeviation 0.4%
SOLVENTNaCl 0.9%compliant
Monitoring

Follow every release in real time.

CPU · control area
Checked144
Compliant140
Deviations4
MonTueWedThuFri
Cisplatin Released
5-Fluorouracil Analysing
Doxorubicin Pending
Dose banding and compounding

Every IV bag analysed individually, whatever the dose.

5-Fluorouracil2,400 mg · dose banding
Compliant
Cisplatin127 mg · compounded
Compliant
Doxorubicin89 mg · compounded
Compliant
Gemcitabine1,800 mg · dose banding
Deviation 7% · alert
Library

Every spectrum compared with validated references.

NNOOFHH
5-FluorouracilC₄H₃FN₂O₂ · 130.08 g/mol
CisplatinPaclitaxelDoxorubicinGemcitabine…
Traceability

One report per IV bag, archived automatically.

Release testing report #894022
Identification: Gemcitabine
Concentration: 8.1 mg/mL (target 8.0)
Solvent: NaCl 0.9%
Analysis in 64 s, recorded in the batch record
Validated by Dr M., pharmacistRELEASED
An analysis, second by second

From injection to verdict in 64 seconds, without leaving the production unit.

The 1 mL sample is drawn beforehand, in the isolator, at the end of the preparation.

Injection

The sample passes into the measuring cell.

UV spectrum

The sample's first spectral signature.

Raman spectrum

A second signature, complementary to the first.

Comparison

Matched against the validated library.

Verdict

Compliant: released. Deviation: pharmacist alerted.

QCRx®

The QCRx® makes no compromises.

It checks what really matters: the finished product. Every IV bag is analysed in under 70 seconds, with no tedious double-checking or video to review. An objective final barrier that never gets tired.

3 in 1molecule, concentration and solvent, with every analysis
< 70 sper analysis, on the finished product
finished productIV bag releasedDeviation detected · alertDouble-checkingVideo controlVigilance
Validation workflow

Built into your validation workflow. One more barrier, without lengthening the workflow.

CLEANROOM · PRODUCTION UNITcontrolled atmosphere areasoftware link: target dose ↔ resultlivecompliantPrescription validatedprescribing softwarePreparationin the isolatorUV × RAMANIV bag releasedchecked, ready to goPatientreceives a verified IV bagQualiright moleculeQuantiright doseSolventright diluentPharmacist's officeproduction monitored liveimmediate releasealert if deviationProduction · CPUlive5-FU 2,400 mgReleasedCisplatin 127 mgReleasedPaclitaxel 175 mgAnalysingGemcitabine 1.8 gAlert · deviation 7%Archiving and traceabilityreport linked to each prescriptionPharmacists and hospitalaudit-ready traceabilityFull traceabilityReady for audit and certificationDocumented decision
  1. Prescription validatedin your prescribing software
  2. Preparationin the isolator, in the cleanroom
  3. QCRx® analysis · UV × Raman1 mL sampled from the finished IV bag, verdict in under 70 s
  4. IV bag releasedchecked, ready to go
  5. Patientreceives a verified IV bag: right molecule, right dose, right solvent
Pharmacist's officeProduction monitored live, immediate release, alert if deviation.
Archiving and traceabilityA report linked to each prescription.
Pharmacists and hospitalAudit-ready traceability, documented decision.
Analytical control

An analytical control solution, without the constraints of conventional analytics.

Analytical control is often criticised for being too slow to release IV bags, for requiring a separate laboratory and analyst skills. The QCRx® was designed the other way round: it is installed in the cleanroom, as close as possible to production, is operated without analytical expertise and gives its verdict before release.

CriterionHPLC / UHPLCFIAQCRx®
Suitable for releaseDifficult, result often too latePossibleDesigned to release every IV bag
Where to install itDedicated laboratoryDedicated laboratoryIn the cleanroom, next to production
Skills requiredQualified analytical technicianSpecific trainingNo analytical expertise
Time per IV bag, from sampling to resultSeveral minutes of separation, plus sample preparationabout 2 minunder 70 s
Setting up a moleculeSeveral hoursSeveral hours30 min per molecule

Also compare with in-process controls: visual, video, gravimetry, robot →


Versatility

One system for all your IV bags. And also eye drops, capsules and some non-sterile preparations.

Chemotherapies
Monoclonal antibodies
Injectable solutions in IV bags
Eye drops
Diluted capsules
Non-sterile preparations

A single protocol for all these preparations. Syringes and infusers are not supported.


Molecules

Which molecules does the QCRx® check? A ready-to-use library that grows with you.

  • Ready to useThe main chemotherapy molecules are already calibrated. You can start checking from installation, with no method development.
  • A new molecule in 30 minutesMissing one? It can be set up in 30 minutes on the QCRx®, compared with several hours for an HPLC or FIA method.
  • The full list on requestThe library is constantly evolving. We send you the up-to-date list and check the molecules of your activity with you.

Request the list of molecules

Reference libraryQCRx® · CPU
  • 5-FluorouracilAntimetabolite · NaCl 0.9% / G5%Ready
  • CisplatinPlatinum salt · NaCl 0.9%Ready
  • PaclitaxelTaxane · NaCl 0.9% / G5%Ready
  • DoxorubicinAnthracycline · NaCl 0.9% / G5%Ready
  • GemcitabineAntimetabolite · NaCl 0.9%Ready
  • Your moleculeAdded to the library with our teamAuto setup
Extract from the library. Full list sent on request.

Your questions, our answers.

What pharmacists most often ask before a demonstration.

I have neither the team nor the skills for analytical control. Is it for me?+
Yes. The QCRx® was designed for hospital pharmacies, not for analytical laboratories. No spectroscopy expertise is required: the interface is intuitive, e-learning training is included and our team supports you from start to finish. Pharmacy technicians use it every day after a few hours of familiarisation.
Which molecules can the QCRx® check?+
The main chemotherapy molecules are already in the library, ready to use: 5-fluorouracil, cisplatin, paclitaxel, doxorubicin, gemcitabine and many others. If a molecule from your activity is missing, it can be set up in 30 minutes. See the library or ask us for the full list.
Do I need building work or a dedicated laboratory in my hospital pharmacy?+
No. The QCRx® is installed directly in your production unit, on a standard worktop. No additional cleanroom, no complex connections. Its footprint is comparable to that of an office printer.
I'm already overloaded. Won't this check slow down my releases?+
Quite the opposite. The complete analysis takes under 70 seconds per IV bag. Compared with manual double-checking or back-and-forth with an HPLC laboratory, it is a clear time saving. And the verdict is automatic: no spectra to interpret.
Is the technology really proven?+
The QCRx® is the 3rd generation of a system developed over 15 years. More than 60 hospital pharmacies use it every day in France, Belgium, Germany and the French overseas territories, amounting to more than a million checks per year. References include Gustave Roussy, AP-HP and Liège University Hospital.
If it breaks down, who steps in? I can't stop my production.+
Our technical team responds quickly, with regular preventive maintenance and corrective repairs. The hotline is available from Monday to Friday and, in the event of a major breakdown, we provide a loan machine. The goal: no interruption to your production.

Ready to secure your releases?

30 minutes with an expert: an assessment of your unit, then a machine demonstration.