Vista-ER Transmission Spectrophotometer.
Vista with Essentials-ER embedded software provides a standalone transmittance color measurement solution designed to help users achieve FDA CFR 21 Part 11 compliance for electronic record keeping. This standalone solution eliminates the need for users to purchase external ER compliant software and computer solutions.
The Vista-ER includes the Validation and Compliance Notebook in PDF form on thumb drive. Hard copy notebooks can be ordered separately.
VISTA-ER VALIDATION AND COMPLIANCE NOTEBOOK INCLUDES:
SECTION 1 – 21 CFR PART 11 COMPLIANCE
What is CFR 21 Part 11
How HL helps customers achieve compliance.
Predicate Rules
Setting up Windows Operating System
Definitions
SECTION 2: IQ/OQ/PQ QUALIFICATION PROTOCOLS
System overview
Qualification protocols overview
Installation Qualification Protocols for hardware and software
Operational Qualification Protocols
Performance Qualification Protocols
HunterLab onsite instrument qualification is also available.
Product Specifications
Measurement Principle: Dual-beam benchtop spectrophotometer
Geometry: Tt/0º or Td/0º per ASTM 1164, CIE 15:2018
Spectrophotometer: 256 element diode array and high resolution, concave holographic grating
Port Size/Measured Area: 18.5 (0.73 in) illuminated/9.8 mm (0.39 in) measured
Measurement Time: 2.5 seconds
Measurement Time with Haze: 5 seconds
Measurement Interval: min 3 seconds
Measurement Pathlength: Up to 100 mm
Transmission Modes: Total (TTRAN) and Regular (RTRAN) and Haze
Standards Conformance
- Colorimetric: CIE 15:2018, ASTM E1164, DIN 5033 Teil 7 and JIS Z 8741 Condition E, G
- Haze: ASTM D1003
