Packages

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.

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.

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.

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.

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.

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.

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.