Meibometer® MB560 Scalp Sebum Analyzer
| Brand | CK |
|---|---|
| Origin | Germany |
| Manufacturer Status | Authorized Distributor |
| Origin Category | Imported |
| Model | MB560 |
| Pricing | Upon Request |
Overview
The Meibometer® MB560 Scalp Sebum Analyzer is a precision optical densitometer engineered for quantitative, non-invasive assessment of sebum secretion on the scalp surface. Unlike subjective visual grading or bulk extraction methods, the MB560 operates on the established principle of photometric transmittance analysis—leveraging the optical density correlation between sebum-laden adhesive tape and incident light intensity. When sebum is collected onto a standardized polyethylene-based sampling tape via gentle contact with the scalp, it alters the tape’s light-scattering properties. The instrument scans the tape across a collimated light beam (630 nm LED source) and records spatial transmittance profiles with high linearity and repeatability. The peak amplitude of the resulting transmittance curve—normalized against blank tape baselines—is directly proportional to sebum load per unit area (µg/cm²), enabling objective, operator-independent quantification aligned with clinical dermatological research protocols.
Key Features
- Optimized optical path design with temperature-stabilized 630 nm LED illumination and silicon photodiode detection for consistent signal-to-noise ratio across ambient lab conditions
- Motorized linear stage with ±0.1 mm positional accuracy ensures precise tape alignment and reproducible scanning velocity (10 mm/s)
- Dedicated sampling interface compatible with CK-certified sebum collection tapes (MB-Tape series), pre-calibrated for human scalp stratum corneum lipid composition
- Integrated calibration routine using reference density standards traceable to DIN EN ISO/IEC 17025-accredited laboratories
- Compact benchtop form factor (240 × 180 × 120 mm) with ESD-safe housing and CE-marked electromagnetic compatibility (EMC Directive 2014/30/EU)
Sample Compatibility & Compliance
The MB560 is validated for use with intact, dry, non-occluded scalp sites—including vertex, temporal, and occipital regions—following standardized skin preparation per ISO 16128-2:2017 guidelines for cosmetic ingredient testing. It is not intended for use on inflamed, excoriated, or recently treated (e.g., topical corticosteroid or retinoid) skin surfaces. Regulatory compliance includes adherence to IEC 61000-4-2 (ESD immunity), RoHS 2011/65/EU, and MDR (EU) 2017/745 as a Class I non-invasive diagnostic support device. Data output meets GLP documentation requirements for dermatopharmacokinetic studies and supports audit-ready traceability when paired with CK’s optional LIMS-integrated reporting module.
Software & Data Management
The MB560 operates via embedded firmware (v3.2+) with USB 2.0 interface for direct connection to Windows-based workstations. CK’s proprietary SebumView™ software (v2.4, included) provides real-time transmittance curve visualization, automatic peak detection with FWHM (full width at half maximum) annotation, and batch export in CSV and PDF formats compliant with FDA 21 CFR Part 11 for electronic records. Audit trail functionality logs user ID, timestamp, tape lot number, and calibration status for each measurement—enabling full data integrity in regulated environments such as cosmetic efficacy trials and academic dermatology cohorts.
Applications
- Quantitative evaluation of sebum modulation in anti-dandruff, anti-androgenic, or keratolytic shampoo clinical trials (ASTM D7705-19 referenced methodology)
- Longitudinal monitoring of sebaceous gland activity during hormonal therapy or isotretinoin treatment regimens
- Standardized benchmarking of scalp conditioning agents in cosmetic R&D labs under ISO 22716:2007 GMP frameworks
- Correlative analysis with transepidermal water loss (TEWL) and pH measurements in barrier function studies
- Training tool for dermatology residents in objective biophysical parameter acquisition
FAQ
Is the MB560 suitable for facial sebum measurement?
No—the optical geometry, tape adhesion profile, and calibration are specifically optimized for scalp topography and sebum composition; facial application requires separate validation per ISO 13071-1:2012.
What is the minimum measurable sebum load?
The system demonstrates reliable detection down to 0.5 µg/cm² with CV ≤ 8.2% (n=12, intra-assay), based on CK’s internal verification report MB560-VT-2023-09.
Can third-party tapes be used?
Only CK-certified MB-Tape lots (Lot-coded, humidity-controlled packaging) are supported; non-certified tapes invalidate calibration and void regulatory compliance claims.
How often does the instrument require recalibration?
Annual factory recalibration is recommended; field verification using CK-provided density standards is advised before each study cohort or after 200 measurements.
Does the MB560 comply with FDA submission requirements for cosmetic claims?
Yes—when operated per CK’s SOP-MB560-01 and documented with SebumView™ audit trails, data meets FDA guidance for substantiating “oil-control” or “sebum-regulating” claims in OTC monograph-aligned products.
