Supelco® 1100IR Portable Economical Turbidimeter
| Brand | Supelco |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Authorized Distributor |
| Product Origin | Domestic (China) |
| Model | 1100IR |
| Price Range | USD 2,800 – 7,000 |
| Type | Portable |
| Measurement Range | 0.01–1100 NTU |
| Resolution | 0.01 NTU (0–100 NTU range) |
| Operating Ambient Temperature | 10–30 °C |
| Accuracy | ±2% of reading or ±0.01 NTU, whichever is greater |
Overview
The Supelco® 1100IR Portable Economical Turbidimeter is an optical measurement instrument engineered for reliable, field-deployable turbidity quantification in compliance with pharmacopeial and regulatory standards—including the Chinese Pharmacopoeia (ChP) 2015 Edition, Section 0902 “Clarity Testing”, Method II (Instrumental Turbidimetry). It operates on the principle of infrared (IR) nephelometry at 850 nm, minimizing interference from sample coloration and absorbance—critical for pharmaceutical solutions, parenterals, biologics intermediates, and purified water streams where chromophoric compounds may otherwise distort visible-light-based measurements. Unlike visual comparison methods (ChP Method I), which introduce subjectivity, inter-observer variability, and reliance on hazardous hydrazine sulfate standard preparation, the 1100IR delivers objective, traceable, and repeatable NTU values. Its compact, battery-powered architecture supports on-site testing in cleanrooms, QC laboratories, manufacturing floors, and environmental monitoring stations without requiring benchtop infrastructure.
Key Features
- Infrared (850 nm) light source ensures minimal spectral interference from yellow/brown-colored samples—enhancing measurement fidelity across APIs, sterile filtrates, and buffer solutions.
- High-resolution detection down to 0.01 NTU within the 0–100 NTU range, supporting both low-turbidity verification (e.g., WFI, Purified Water per USP ) and higher-range process monitoring (up to 1100 NTU).
- Integrated calibration validation: pre-formulated, NIST-traceable turbidity standards (Formazin or AMCO AEPA equivalents) are supplied in ready-to-use vials—eliminating manual reagent handling and associated safety risks.
- Robust, IP65-rated housing with rubberized grip and shock-absorbing design optimized for transport between labs and production suites.
- Onboard memory stores up to 500 measurement records with timestamp, operator ID, and calibration history—enabling full audit trail generation.
- USB-C interface supports direct data export to LIMS or Excel-compatible CSV files; optional Bluetooth module available for wireless transmission to validated mobile applications.
Sample Compatibility & Compliance
The 1100IR accepts standard 25-mm round glass or disposable plastic cuvettes (10 mm path length), accommodating volumes from 10–15 mL. It is validated for use with aqueous matrices including purified water, water for injection (WFI), saline solutions, diluted biological suspensions, and clarified fermentation broths. The instrument meets essential requirements of ISO 7027-1:2016 (water quality — determination of turbidity — nephelometric method), aligns with USP and EP 2.2.1 for turbidity assessment of injectables, and supports GLP/GMP data integrity through configurable user access levels and electronic signature capability. Full 3Q documentation (Installation Qualification, Operational Qualification, Performance Qualification) is available upon request and includes protocol templates compliant with FDA 21 CFR Part 11 and EU Annex 11 expectations.
Software & Data Management
The instrument operates via embedded firmware with intuitive icon-driven navigation and multilingual UI (English, Simplified Chinese, Spanish). Data export adheres to ALCOA+ principles: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available. Each stored record includes instrument serial number, calibration date, standard lot number, ambient temperature, and measurement duration. Optional Supelco Turbidity Manager Software (v3.2+) provides advanced reporting tools—including trend analysis, pass/fail flagging against user-defined limits, and automated PDF report generation with digital signature fields for QA sign-off. All software modules undergo periodic cybersecurity review and maintain backward compatibility with legacy calibration datasets.
Applications
- Pharmaceutical QC: Clarity testing of injectables, ophthalmic solutions, and lyophilized reconstitution fluids per ChP 2015, USP , and JP XVII.
- Bioprocess support: Monitoring filter integrity, harvest clarity, and diafiltration endpoint during downstream purification.
- Water system validation: Routine surveillance of PW/WFI distribution loops and point-of-use sampling points.
- Environmental health: Field assessment of rinse water clarity post-CIP/SIP cycles and HVAC humidifier condensate.
- Educational labs: Teaching quantitative optical scattering theory, Beer–Lambert deviations, and regulatory metrology fundamentals.
FAQ
Does the 1100IR comply with Chinese Pharmacopoeia 2015 Method II for turbidity measurement?
Yes—the optical configuration, wavelength selection, and calibration protocol are explicitly designed to satisfy ChP 2015 Section 0902 Method II requirements.
Can it measure colored samples without compensation artifacts?
The 850 nm IR detection significantly reduces absorbance-related error compared to 400–600 nm visible-light turbidimeters; however, extreme pigment loading (>0.5 AU at 850 nm) may require matrix-matched calibration.
Is third-party 3Q qualification supported?
Supelco-certified service engineers provide IQ/OQ/PQ execution globally, including documentation aligned with ISO/IEC 17025 and client-specific SOPs.
What is the recommended recalibration frequency?
Daily verification with primary standard is advised before first use; full calibration every 72 operating hours or per internal QA schedule—whichever occurs sooner.
Are replacement cuvettes and standards supplied by Supelco?
Yes—certified Formazin-equivalent standards (0.02, 10, 100, 800 NTU) and borosilicate glass cuvettes (Cat. No. 1100-CUV-SET) are stocked and shipped with full CoA.
