Authorised Indian Distributor
Saxsons Group
New Delhi, India · Since 1997
MUCHA NovaMulti-Channel Gamma Analyser for Nuclide Identification + Radionuclidic Purity
Multi-channel gamma analyser for radionuclide identification and radionuclidic-purity testing. NaI(Tl) standard chassis or HPGe high-resolution chassis (MUCHA Nova HR). Touchscreen-driven hot-lab workflow with automatic energy calibration on startup. Comprehensive nuclide library covers diagnostic and therapeutic radionuclides. SQL audit-trail database records every spectrum, every operator signature, every release decision — 21 CFR Part 11 compliant.
Key Features
- Multi-channel analyser optimised for the radiopharmacy radionuclide-identification workflow
- NaI(Tl) scintillation standard chassis covers the daily release programme; HPGe high-resolution chassis (MUCHA Nova HR) resolves close-lying lines
- Automatic energy calibration on instrument startup — ready to measure on first sample
- Comprehensive radionuclide library covers diagnostic + therapeutic isotopes (Tc-99m, F-18, Ga-68, Lu-177, I-131, Cu-64, Mo-99, Ge-68 and more)
- Automatic peak matching against the library; PASS / FAIL on radionuclidic-purity threshold returned per-batch
All Features
- Multi-channel analyser optimised for the radiopharmacy radionuclide-identification workflow
- NaI(Tl) scintillation standard chassis covers the daily release programme; HPGe high-resolution chassis (MUCHA Nova HR) resolves close-lying lines
- Automatic energy calibration on instrument startup — ready to measure on first sample
- Comprehensive radionuclide library covers diagnostic + therapeutic isotopes (Tc-99m, F-18, Ga-68, Lu-177, I-131, Cu-64, Mo-99, Ge-68 and more)
- Automatic peak matching against the library; PASS / FAIL on radionuclidic-purity threshold returned per-batch
- Live spectrum display during acquisition — flag unexpected lines before the run completes
- Touchscreen dialog-guided interface; minimal operator training to release-grade routine work
- Configurable low / medium / high energy ranges per measurement — same chassis covers SPECT and PET isotopes
- Background spectrum accumulation and automatic subtraction maintain limit-of-detection over service life
- SQL audit-trail database stores every spectrum, operator signature, calibration record and release decision; 21 CFR Part 11 compliant
- AERB hot-lab QC fit: instrument operates inside the radiopharmacy licence; release-record format meets AERB inspection expectations
- Documentation: datasheet, IQ / OQ / PQ protocols, calibration certificate, 21 CFR Part 11 validation evidence
Technical Specifications
| Analyser type | Multi-channel analyser (MCA) for gamma spectrometry |
| Detector chassis | NaI(Tl) scintillation (standard); HPGe (MUCHA Nova HR high-resolution variant) |
| Energy ranges | Low, medium and high — operator-selectable per measurement |
| Nuclide library | Comprehensive — diagnostic and therapeutic radionuclides; expandable for IIP work |
| Identification method | Automatic peak matching against the library; radionuclidic-purity threshold check |
| Energy calibration | Automatic on startup; multi-source protocols supported (Cs-137 / Co-57 / Co-60) |
| Background management | Automatic accumulation and subtraction; periodic background-update protocol |
| Interface | Touchscreen; dialog-guided workflow for hot-lab operator |
| Data storage | SQL audit-trail database; spectrum file export; printer output for batch record |
| Shielding (HR chassis) | Enhanced lead shielding — lowest achievable background for HPGe high-resolution work |
| Compliance framework | AERB hot-lab QC, Eur.Ph. radionuclidic-purity monographs, USP <823>, 21 CFR Part 11 |
| Validation | IQ / OQ / PQ protocols supplied; site PQ scheduled during install |
Applications
Know your isotope before it reaches the patient — and document it for the inspector
Radionuclidic-purity release
Mandatory per-batch QC for diagnostic and therapeutic radiopharmaceuticals. The MCA spectrum confirms the intended radionuclide and rules out generator-breakthrough or cyclotron-by-product contamination. Eur.Ph. monographs cite gamma-spectrometric methods explicitly.
Mo-99 breakthrough check
Generator-eluate QC — distinguishes the 140 keV Tc-99m line from 740 / 780 keV Mo-99 breakthrough lines in a single gamma spectrum. Faster and more sensitive than dose-calibrator shielded-attenuator methods alone.
Ge-68 breakthrough check
Ge-68 / Ga-68 generator eluate QC. The delayed-spectrum check after Ga-68 decay catches residual Ge-68 against the Eur.Ph. breakthrough limit (< 0.001 % at expiry).
Lu-177 nuclide identity
Theranostic-batch QC — confirms the 113 / 208 keV Lu-177 doublet and checks for the 228 keV Lu-177m peak that distinguishes carrier-added from n.c.a. supply. Pairs with the radio-TLC %RCP on the same batch record.
Cyclotron target analysis
Quantifies radionuclidic impurities in cyclotron-produced F-18, Ga-68 and Cu-64 — identifies co-produced isotopes and confirms target-material activation profile. The live spectrum display flags unexpected co-productions early in the count.
Waste characterisation + audit
Identify and quantify radionuclides in the hot-lab waste stream for decay-in-storage planning. The same nuclide library covers environmental monitoring, sealed-source audit and inspection-prep gamma surveys.
Why MUCHA Nova?
Automatic peak matching against a comprehensive library — no manual peak assignment. The operator sees PASS / FAIL on the radionuclidic-purity threshold and the library-matched primary isotope; the inspector sees the same on the release record.
The spectrum builds in real time on the touchscreen during acquisition. Unexpected peaks — cyclotron co-productions, generator-breakthrough events, contamination from adjacent activity — show up before the count completes; the operator can intervene before reporting.
Every spectrum, every operator signature, every calibration record stored in the SQL audit-trail database. The AERB inspector reads the same release record off the database that the radiopharmacist signed at release — no parallel paper log to reconcile.
Catalogs & Resources
Pharmacopeial + AERB + IAEA references that anchor the radionuclidic-purity release workflow. Contact Saxsons for India pricing, install scheduling and IQ / OQ / PQ documentation.
IAEA TRS 466 — Quality Assurance for PET and PET/CT Systems
IAEA technical report covering PET radiopharmacy QC including radionuclidic-identity and gamma-spectrometric methods.
Eur.Ph. — Radiopharmaceutical Preparations general monograph
European Pharmacopoeia general + per-isotope monographs defining radionuclidic-purity thresholds and acceptable measurement methods.
AERB Safety Code for Nuclear Medicine Facility
Indian regulatory framework for nuclear-medicine facility licensing including hot-lab QC, radionuclidic-purity and release-record expectations.
MUCHA Nova
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Each card opens a focused post for a specific specialty — peer-reviewed evidence and clinical workflow, written for the persona you select.
FAQ
Multi-channel gamma analyser — questions we hear from Indian radiopharmacy teams
What USP <823> radionuclide identity and radionuclidic purity actually cover, when to pick HPGe HR over NaI(Tl), what the automatic energy calibration saves, and what the 21 CFR Part 11 audit trail delivers for AERB inspection.
Q.What QC test on a radiopharmaceutical batch does MUCHA Nova cover?
Radionuclide identification and radionuclidic-purity testing — two USP <823> mandatory release tests that verify (a) the activity in the vial is actually the isotope claimed on the label and (b) there is no significant contamination by other isotopes. Both are gamma-spectrometry measurements: MUCHA Nova reads the gamma spectrum, matches the peaks to a nuclide library, quantifies each contaminant against the release specification and signs the pass / fail record.
Q.When should the department pick the NaI(Tl) standard chassis over the HPGe HR chassis?
NaI(Tl) has good sensitivity and lower resolution; HPGe has excellent resolution and requires liquid-nitrogen or cryocooler cooling. For routine radionuclidic-identity work on well-separated isotope peaks (Tc-99m vs I-131, Lu-177 vs Ga-68), NaI(Tl) is sufficient and simpler to maintain. For close-peak resolution — Lu-177m breakthrough on Lu-177 batches, Zn-68 contamination on Ga-68 eluate — the HR chassis is the right pick.
Q.How does the automatic energy calibration on startup save daily QC time?
A gamma spectrometer's energy scale drifts with temperature and detector age. On a legacy spectrometer the operator runs a manual energy calibration every morning with a check source. MUCHA Nova performs the calibration automatically on startup — the department opens the software and the instrument is verified against the reference peak positions before the first QC run. That is a routine 10-minute manual step collapsed to a hands-off boot cycle.
Q.What audit-trail requirement does the SQL database + 21 CFR Part 11 signature fulfil?
EU GMP Annex 3, USP <823>, AERB Safety Code and CDSCO all expect a tamper-evident QC record for every batch — timestamp, operator, spectrum acquired, nuclide match, contaminant quantification, pass / fail decision, release signature. Paper records are increasingly not accepted at audit. MUCHA Nova's SQL audit trail captures every one of those steps as a queryable digital record — the inspector reads the log without asking the operator to reconstruct.
Q.How is MUCHA Nova supplied and supported in India?
Distributed across India by Saxsons Group. Supply covers the analyser (NaI(Tl) or HPGe HR chassis), nuclide-library configuration for the department's isotope mix, commissioning against the hot-lab QC workflow, 21 CFR Part 11 software validation and applications training. Imported under CDSCO Medical Devices Rules 2017.
MUCHA Nova supplier in India — Saxsons Group
Saxsons Group has supplied nuclear medicine equipment to over 1,000 Indian hospitals since 1988. Every consignment of MUCHA Nova ships with cold-chain logistics, AERB import documentation, CDSCO registration references and a Certificate of Analysis delivered before dispatch — the paperwork your radiation-safety and procurement teams need, pre-assembled.
- Nationwide delivery footprint — every metro and tier-2 city in India, scheduled to your treatment / procedure calendar.
- AERB & CDSCO documentation — import licence, radiation-safety paperwork and RSO briefing pre-assembled for the audit file.
- 40+ years in Indian oncology — long-standing supply relationships with AIIMS, Tata Memorial, and hundreds of tertiary-care centres.
- Single point of accountability — one purchase order, one delivery contact, one after-sales team across the whole product family.
Also supplied by Saxsons Group across India
Gold-standard gamma spectrometry for the radionuclidic-purity gate
Contact Saxsons Group for MUCHA Nova supply (NaI / HPGe HR chassis), India install scheduling, IQ / OQ / PQ documentation and AERB-aligned operator training.