Packages

RPH combines PetRad, PetRad2 and PetRad3 into one umbrella package for PET/SPECT, therapeutic radionuclides, generators, labelled compounds, decay calculations, sterility, endotoxins and radiochemical/radionuclidic purity.

29 utilities for the hyperpolarized xenon lifecycle: isotope composition and gas purity, SEOP and polarization, T1/storage/transport, safe blending and delivery, MRI/SPECT QC, dosimetry, scavenging, recovery and recycling.

16 utilities covering the Tc-99m renal workflow: generator eluate and Mo-99 breakthrough, Sn(II), labeling stoichiometry and pH, radiochemical purity and stability of MAG3, DTPA, DMSA(III) and glucoheptonate, gamma-camera uniformity, renal uptake and plasma clearance, bladder voiding efficiency, patient dosimetry and decay-in-storage waste management.

36 utilities for clinically oriented radiopharmaceutical and workflow quality control: PET/SPECT tracers, the Tc-99m renal workflow, PRRT, PSMA therapy, targeted alpha therapy, radioembolization, bone-pain palliation, immuno-PET and generator-based radionuclide control.

14 utilities for PET/PET-CT scanner state control: Ge-68/Ga-68 source activity, blank sinogram, detector efficiency, normalization acquisition and factor distribution, normalization-file assignment, trending, energy window, TOF, attenuation-correction map, PET/CT cross-calibration and the daily operational decision.

LabEx package for laboratory QC methods: chromatography, spectroscopy, microbiology, sterility, endotoxins, particles, dissolution, water, cleanrooms and sample preparation.

A single Lumex package combining the former Lumex and Lumex2 sets: instrumental and general pharmaceutical QC, AAS/ICP, CE, HPLC, NIR/PAT, stability, dissolution, content uniformity, system suitability and statistical control.

Quality-control package for vitamins, minerals, premixes and nutrient substances.

Quality-control package for contraceptives: hormonal APIs, fixed combinations, implants, rings and intrauterine systems.

Utilities for activity, dosimetry, brachytherapy sources, small-field corrections and TG-43 parameters.

Huvac contains QC utilities for human vaccines: adjuvants, antigen potency, sterility, endotoxins, cold chain, mRNA controls, container closure and stability checks.

Vet is designed for veterinary pharmaceuticals and vaccines: adjuvants, antigens, autogenous vaccines, aquaculture, feed/premixes, antimicrobial and antiparasitic products, sterility and batch release.

QC package for diabetes medicines: insulins, metformin, SGLT2/DPP-4/GLP-1 products, glucagon and supporting dosage-form quality checks.

QC and pre-analytical control package for liquid biopsy workflows: cfDNA/ctDNA, CTC, EV/exosomes, methylation, NGS/qPCR/ddPCR, sample quality, contamination, sensitivity and reporting checks.

Package for sterile liquids, infusion solutions, dialysis solutions, contrast media and water for injections.

Quality-control package for medical and pharmaceutical gases: oxygen, nitrogen, carbon dioxide, nitrous oxide, helium and mixtures.

Package for injectable implants and dermal fillers: hyaluronic acid, CaHA, PLLA, PMMA, collagen and related tests.

Focused QC utility package for biologic products: HCP, mAbs, biosimilars, proteins/peptides, sterility, endotoxins and key release checks.

Extended QC utility coverage for mAbs, biosimilars, proteins, insulins, vaccines, mRNA/LNP, HCP, sterile release, microbiology, water, cleanroom and stability workflows.

QC package for radiology and diagnostic imaging: radiopharmaceuticals, PET/SPECT, contrast media, iodinated and gadolinium products, plus particle, sterility and endotoxin checks.

Package for EAEU pharmacopoeial methods: specifications, dissolution, microbiology, impurities and general tests.

Utility package for British Pharmacopoeia monographs covering drug substances, APIs and finished products.

Utilities for general pharmacopoeial methods and tests in the European regulatory context.

Large utility package for herbal drugs, botanicals and phytopharmaceutical monographs.

Extended package for 130 additional high-demand APIs and biological products prepared as a market-coverage backlog.

QC utility package for dental medicinal products, oral-care products and dental materials: anaesthetics, antiseptics, analgesic/anti-infective products, polymers/minerals, resins, bonding workflows, microbiology, stability and material QC.

QC utility package for infectious diseases: antibacterial, antiviral, antifungal and antiparasitic products, microbiology, sterility, endotoxins, viral safety and vaccine release checks.

QC utility package for immunology: monoclonal antibodies, biosimilars, immunomodulators, immunosuppressants, ELISA/SPR, HCP, protein characterization, sterility and pyrogen/release checks.

QC utility package for toxicologically relevant risks: genotoxic impurities, residual solvents, elemental impurities, heavy metals, mercury, mycotoxins, pesticides, extractables/leachables and degradation impurities.

QC utility package for addiction medicine and regulated medicinal products: addiction-treatment medicines, opioids, benzodiazepines, stimulants, sedatives, volatile impurities, assay/identity/dissolution/release checks.

Package for high-demand global APIs, generics and biosimilars, including fixed-dose combinations and biological products.

QC utility package for Ayurvedic products, botanical raw materials, Bhasma/Rasa Shastra, fermented preparations, lipid matrices and finished products.

QC utility package for TCM: botanical identity, fingerprint consistency, marker compounds, decoction pieces, Paozhi processing, pesticides, mycotoxins, heavy metals, sulfur fumigation, microbial limits and adulteration screening.

QC package for cardiology medicines: antihypertensives, anticoagulants, antiplatelets, lipid-lowering and antiarrhythmic medicines plus supporting QC checks.

QC package for neurology and neuropsychiatry: antiepileptics, antiparkinsonian medicines, antidepressants, antipsychotics, analgesics and neurological diagnostic radiopharmaceuticals.

QC package for endocrinology: thyroid, pituitary/peptide hormones, corticosteroids, sex hormones and selected metabolic medicines.

QC package for rheumatology: NSAIDs, glucocorticoids, methotrexate, biologics and supporting impurity/potency checks.

QC package for gastroenterology: PPIs, antiemetics, prokinetics, IBD medicines, laxatives, enzymes and GI anti-infectives.

QC package for urology: BPH, urolithiasis, overactive bladder, urinary-tract infection medicines and supporting antimicrobial QC checks.

QC package for gynecology: hormones, contraceptives, uterotonics, anti-infectives and women’s-health medicines.

QC package for ophthalmology: eye drops, antiglaucoma agents, antibiotics, sterile solutions, osmolality, pH, particles and preservatives.

QC package for ENT: nasal sprays, ear drops, local antiseptics, corticosteroids, antibiotics and upper-airway medicines.

QC package for proctology: local anaesthetics, corticosteroids, anti-inflammatory, anti-infective and supporting medicines for rectal dosage forms.

QC package for andrology: androgens, erectile-dysfunction medicines, BPH/prostate products, fertility and related hormonal checks.

A specialised utility package for radiopharmaceutical quality control: PET, SPECT, therapeutic radionuclides, generators and decay calculations.

A curated set of new utilities for radionuclide control, targeted alpha therapy, specific activity, radiolysis stability and preliminary dosimetry calculations.

A curated suite for PET/SPECT radiopharmaceuticals, generator and cyclotron radionuclides, labelled compounds, radiochemical purity, breakthrough, sterility and endotoxin control.

ADC / Conjugated Biologics QC Suite: FUZKK utility package for CSV→JSON QC checks with EU-first limit priority.

Cell & Gene Therapy / Viral Vector QC Suite: FUZKK utility package for CSV→JSON QC checks with EU-first limit priority.

Fermentation & Antibiotic Intermediates QC Suite: FUZKK utility package for CSV→JSON QC checks with EU-first limit priority.

Herbal / TCM / Ayurveda Instrumental QC Suite: FUZKK utility package for CSV→JSON QC checks with EU-first limit priority.

Inhaled Products QC Suite: FUZKK utility package for CSV→JSON QC checks with EU-first limit priority.

mRNA/LNP Quality QC Suite: FUZKK utility package for CSV→JSON QC checks with EU-first limit priority.

Ophthalmic & Intravitreal QC Suite: FUZKK utility package for CSV→JSON QC checks with EU-first limit priority.

Peptides, GLP-1 and Obesity QC Suite: FUZKK utility package for CSV→JSON QC checks with EU-first limit priority.

Plasma-Derived Products QC Suite: FUZKK utility package for CSV→JSON QC checks with EU-first limit priority.

Radioligand & Theranostics Expansion QC Suite: FUZKK utility package for CSV→JSON QC checks with EU-first limit priority.

Medical Devices package for ISO 13485, ISO 14971, IEC 62304, cybersecurity, usability, biocompatibility, sterilization, EMC and UDI/labeling.

FDA Medical Device Compliance Suite: specialised Medical Devices standards/lifecycle utility subpackage.

Biocompatibility Suite: specialised Medical Devices standards/lifecycle utility subpackage.

Cybersecurity for Medical Devices Suite: specialised Medical Devices standards/lifecycle utility subpackage.

Electrical Safety & EMC Suite: specialised Medical Devices standards/lifecycle utility subpackage.

Medical Device QMS Suite: specialised Medical Devices standards/lifecycle utility subpackage.

Medical Device Risk Management Suite: specialised Medical Devices standards/lifecycle utility subpackage.

Medical Device Software Suite: specialised Medical Devices standards/lifecycle utility subpackage.

UDI & Labeling Suite: specialised Medical Devices standards/lifecycle utility subpackage.

Usability Engineering Suite: specialised Medical Devices standards/lifecycle utility subpackage.

Sterile Medical Devices Suite: specialised Medical Devices standards/lifecycle utility subpackage.

Quality control of Tc-99m MAA, particle size and count, suspension stability, lung perfusion studies, lung-shunt estimation, pre-therapy dosimetry and concordance with Y-90 distribution.

Quality control of HIDA, mebrofenin and disofenin, hepatic extraction and gallbladder ejection calculations, and hepatobiliary transit review.

Tc-99m HMPAO leukocyte labelling, labelling efficiency, cell viability and recovery, free activity, process time and temperature, and pre-reinjection release.

Sodium pertechnetate Tc-99m quality control and thyroid, salivary-gland, Meckel diverticulum and ectopic gastric-mucosa imaging workflows.

Red-cell mass and blood-volume calculations, Cr-51 labelling efficiency, elution correction, recovery-curve analysis and sample-timing control.

Gastric-emptying and GI-transit review, labelled-RBC gastrointestinal bleeding scintigraphy and Tc-99m colloid liver/spleen studies.

Tc-99m DTPA aerosol and Technegas control, aerosol-deposition review, V/Q mismatch evaluation and V/Q acquisition completeness.

Tc-99m nanocolloid and tilmanocept control, injection review, acquisition QC, node-detection threshold and shine-through assessment.

In-111 and Tc-99m platelet labelling, cell recovery, autologous-cell release and cell-viability control.

Ga-67 citrate, Tc-99m sulesomab and Tc-99m besilesomab control, plus antigranulocyte imaging acquisition review.

Renal radiopharmaceuticals and calculation workflows: MAG3, DTPA, DMSA, glucoheptonate, generator Tc-99m, dynamic renography, GFR/ERPF and dosimetry.

Macroaggregated albumin: particle size and count, radiochemical purity, resuspension, lung perfusion, lung shunt and pre-therapy Y-90 planning.

Hepatobiliary tracers, pertechnetate for Meckel/gastric mucosa, gastric emptying, GI transit, RBC bleeding and liver/spleen sulfur colloid.

Leukocytes, red blood cells, platelets and autologous cell workflows: labeling efficiency, viability, free activity, recovery and release before reinjection.

Pertechnetate as a standalone radiopharmaceutical and starting material: thyroid uptake, salivary glands, Meckel scan, gastric mucosa and generator/eluate control.

Sestamibi, tetrofosmin, MDP, pyrophosphate, thallium and related quality checks for cardiology, bone imaging and classic SPECT protocols.

F-18, Ga-68, Cu-64, Zr-89, In-111 and other diagnostic tracers: synthesis, purity, receptor targeting, immuno-PET and generator-based workflows.

Lu-177, Ac-225, Ra-223, Y-90, Ho-166, Sm-153, Sr-89, Re-188, Tb-161, I-131 and other therapeutic radiopharmaceuticals: activity, purity, free metal, daughters and toxicological constraints.

Control of generator eluate, breakthrough, radionuclidic purity, isotope mix, carrier/free radionuclides and starting radionuclides before labeling.

Xe-129, Xe-133, Xe-127, hyperpolarization, SEOP, T1, mixing, scavenging, transport, recovery and ventilation imaging.

The linked medical-device/radiation-physics layer: PET detector QC, normalization, AC map, cross-calibration, TOF, gamma-camera uniformity, source strength and staff dose.

Tc-99m radiopharmaceuticals, kit preparation, generator control, SPECT workflows and calculation utilities.

F-18, C-11, N-13, O-15 and related PET production, release and imaging workflows.

Ga-67, Ga-68 and Ge-68: generator, radiolabelling, PET/SPECT and purity workflows.

I-123, I-124, I-125 and I-131 for diagnostics, therapy, labelling and purity control.

Lu-177, Y-90, Ho-166, Re-188, Sm-153, Sr-89, P-32, Cu-67 and Tb-161.

Ac-225, Ra-223, At-211, Bi-213 and Th-227: targeted alpha therapy and daughter/recoil control.

Cu-64, Zr-89, I-124, Mn-52 and Y-86 for antibodies, slow kinetics and extended imaging.

In-111 and Cr-51 for labelled cells, blood volume, RBC/WBC and survival workflows.

Rb-82/Sr-82, N-13 and Tl-201 for myocardial perfusion and generator-supported workflows.

Xe-127, Xe-129 and Xe-133 for ventilation, hyperpolarized imaging, gas QC and safety.

Renography, GFR/ERPF, renal uptake, DMSA/MAG3/DTPA and bladder-related workflows.

Lung perfusion, MAA, V/Q, aerosol, xenon ventilation, shunt and pulmonary dosimetry.

HIDA, mebrofenin, gallbladder, gastric emptying, GI transit, bleeding and liver/spleen imaging.

Myocardial perfusion, cardiac PET/SPECT, ventricular function, blood-pool and perfusion tracers.

Brain perfusion, dopamine transporter, amyloid/tau, receptor imaging and neurological SPECT/PET.

Radioiodine, thyroid/parathyroid, somatostatin receptor, MIBG and neuroendocrine workflows.

Bone scintigraphy, MDP/PYP, marrow, bone-pain palliation, skeletal metastases and radiosynovectomy.

WBC/RBC/platelet labelling, blood volume, survival, blood-pool and cellular release workflows.

Sentinel node, lymphoscintigraphy, nanocolloid, labelled leukocytes, granulocyte and inflammatory imaging.

Tumour imaging, PSMA/FAPI/receptor tracers, immuno-PET, targeted radionuclide therapy and radioembolization.

Radiolabelling, synthesis, chelation, reducing agent, pH/stoichiometry and kit preparation.

Assay, purity, sterility, endotoxins, pH, impurities, appearance and batch-release checks.

Generator eluate, breakthrough, radionuclidic purity, isotope mix and starting radionuclides.

Activity planning, absorbed dose, organ dose, lung shunt, preplanning and therapy verification.

Acquisition, uptake, clearance, perfusion, transit, ejection fraction, segmentation and quantitative imaging.

Kinetic stability, shelf life, decay correction, expiry, storage, trend and radioactive waste.

PET/gamma-camera state, calibration, detector QC, energy window, TOF, shielding and radiation safety.