SPF-290AS Non-In Vivo Sun Protection Factor Testing System by CK Instruments
| Brand | CK |
|---|---|
| Origin | USA |
| Distributor Type | Authorized Distributor |
| Origin Category | Imported |
| Model | SPF-290AS |
| Pricing | Upon Request |
Overview
The SPF-290AS Non-In Vivo Sun Protection Factor Testing System, engineered by CK Instruments (USA), is a laboratory-grade optical instrumentation platform designed for quantitative, standardized assessment of ultraviolet (UV) attenuation performance of topical sunscreen formulations—without human or animal testing. It operates on the principle of spectrophotometric transmittance measurement across the biologically relevant UVB (290–320 nm) and UVA (320–400 nm) spectral ranges. The system utilizes a calibrated deuterium/halogen light source, precision monochromator, and thermoelectrically stabilized photodetector to deliver high-reproducibility absorbance data from sunscreen films applied uniformly onto synthetic stratum corneum mimetic substrates (e.g., PMMA or polystyrene plates, or proprietary adhesive tapes). Results are processed in accordance with ISO 24443:2021 (“Cosmetics — Sun protection test methods — In vitro determination of sun protection factor (SPF)”) and ASTM D7566-22 Annex A1, enabling regulatory-compliant pre-screening and formulation development.
Key Features
- Automated wavelength scanning from 290 nm to 400 nm at 1 nm resolution, with spectral bandwidth ≤ 2 nm FWHM
- Integrated sample stage with motorized XYZ positioning and pressure-controlled film deposition fixture for consistent 2.0 mg/cm² application density
- NIST-traceable radiometric calibration using certified reference standards (SRMs 2069, 2035)
- Thermal stabilization of optical path (< ±0.1 °C) to minimize drift during extended acquisition cycles
- Dual-beam configuration with real-time reference channel compensation for lamp intensity fluctuations
- Compliance-ready audit trail functionality with user authentication, electronic signatures, and timestamped event logging
Sample Compatibility & Compliance
The SPF-290AS accommodates standard 25 mm × 75 mm adhesive substrate strips (CK Part #Tape-SPF-01) and flat-bottom quartz cuvettes for liquid-phase screening. It supports both emulsion-based lotions and anhydrous oil-soluble filters—including organic UV absorbers (e.g., avobenzone, octinoxate) and inorganic particulates (e.g., micronized ZnO, TiO₂). All hardware and firmware comply with ISO/IEC 17025:2017 requirements for testing laboratories, and software architecture adheres to FDA 21 CFR Part 11 principles for electronic records and signatures. Data outputs satisfy documentation requirements for EU Cosmetics Regulation (EC) No 1223/2009 Annex VIII and ASEAN Cosmetic Directive Annex 5.
Software & Data Management
The bundled SPF Analysis Suite v4.2 provides instrument control, spectral acquisition, and automated SPF calculation per the critical wavelength (λc) and UV absorbance integral methodology defined in ISO 24443. Raw absorbance spectra, baseline-corrected transmittance curves, and derived parameters—including UVAPF (UVA Protection Factor), critical wavelength (λc ≥ 370 nm), and Boots Star Rating equivalents—are exportable in CSV, PDF, and XML formats. Audit logs record all user actions, method changes, calibration events, and data exports. Optional LIMS integration via ASTM E1467-compliant API enables traceability across R&D, QC, and regulatory submission workflows.
Applications
- Pre-clinical screening of new UV filter combinations and photostabilizer efficacy
- Batch-to-batch consistency verification for commercial sunscreen manufacturing
- Stability assessment under accelerated aging (UV exposure, thermal cycling, humidity)
- Regulatory dossier preparation for Health Canada, ANVISA, MFDS, and TGA submissions
- Supporting claims substantiation for broad-spectrum, water-resistant, and pediatric formulations
- Method transfer between contract research organizations (CROs) and in-house labs under GLP conditions
FAQ
Does the SPF-290AS require daily recalibration?
No—NIST-traceable factory calibration remains valid for 12 months under normal operating conditions; however, a quick performance verification using CK’s UV Reference Tape (Cat. #REF-SPF-01) is recommended before each analytical session.
Can it measure spray or stick formulations?
Yes, when applied via standardized applicators (e.g., CK Spray Deposition Kit or Rotating Rod Applicator) onto compatible substrates, with protocol adjustments validated per ISO 24443 Annex B.
Is the software compliant with 21 CFR Part 11?
Yes—SPF Analysis Suite v4.2 includes role-based access control, electronic signature capture, immutable audit trails, and secure data archiving features fully aligned with Part 11 Subpart B requirements.
What maintenance is required beyond lamp replacement?
Annual preventive maintenance includes optical alignment verification, monochromator grating inspection, detector linearity validation, and environmental sensor calibration—all documented in the service log per ISO/IEC 17025 clause 6.4.3.
