Insoluble Particle Detector
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| Brand | Acona |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Region of Origin | Domestic (China) |
| Model | Acona A2000 SIS |
| Price Range | USD 1,400 – 63,000 |
| Brand | Acona |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Regional Category | Domestic (China) |
| Model | Acona A2000SIS CP/USP |
| Price Range | USD 1,400 – 63,000 |
| Brand | Acona |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Model | Acona A2000SIS |
| Price Range | USD 1,400 – 63,000 |
| Detection Principle | Single Particle Optical Sensing (SPOS) with Dual-Mode Extinction & Light Scattering |
| Dynamic Range | 0.5–400 µm |
| Minimum Sample Volume | 50 µL |
| Resolution | 0.01 µm (1024-channel binning) |
| Sensitivity | 10 ppt (particles per trillion) |
| Compliance | USP <787>, USP <729>, FDA 21 CFR Part 11, cGMP/GLP |
| Software Features | Audit Trail, Role-Based Access Control, Electronic Signatures, LIMS Integration, Automated Pass/Fail Reporting |
| Brand | Acona |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Product Category | Domestic |
| Model | Acona2000SIS |
| Price Range | USD 1,400 – 63,000 |
| Brand | Herolab |
|---|---|
| Origin | Germany |
| Model | PM-200 |
| Detection Principle | Light Obscuration (LO) |
| Particle Size Range | 1–200 µm or 2–400 µm (user-selectable) |
| Concentration Range | 0–70,000 particles/mL |
| Minimum Sample Volume | 100 µL |
| Measurement Accuracy | >95% |
| Compliance | USP <787>, <788>, <789>, <1787>, <1788> |
| Software | SW-CA with Audit Trail, Electronic Signatures, and Secure Data Management |
| Syringe Compatibility | 1 mL, 5 mL, 10 mL, 25 mL (interchangeable) |
| Interface | USB |
| Brand | Hongweiliangzi |
|---|---|
| Origin | Shandong, China |
| Model | HW-06S |
| Measurement Range | 1–500 µm |
| Channel Options | ≥5, ≥8, ≥10, ≥12, ≥25, ≥100 µm (customizable) |
| Pharmacopoeia-Compliant Channels | ≥10 µm, ≥25 µm |
| Sample Volume Range | 0.1–1000 mL |
| Minimum Sample Volume | ≥0.1 mL |
| Volume Accuracy | < ±0.5% |
| Counting Range | 0–9,999,999 particles |
| Particle Concentration Range | 0–10,000 particles/mL |
| RSD | ≤2% (for standard particles ≥1000 particles/mL) |
| Sampling Time | <8 s for 5 mL |
| Time Accuracy | ±5% of set value |
| Channel Resolution | ≥95% (≥10 µm channel) |
| Stirring Speed | 0–2000 rpm, continuously adjustable |
| Operating Temperature | 0–40 °C |
| Power Supply | AC 220 V ±10%, 50 Hz, ≤90 W |
| Dimensions | 360 × 330 × 415 mm |
| Brand | Octopus |
|---|---|
| Origin | Germany |
| Model | SAMILLA FIM |
| Detection Principle | High-Resolution Flow Imaging Microscopy (HiRes-FIM) |
| Particle Size Range | 0.2 µm – 2 mm |
| Camera Options | 12 MP monochrome or color, high-frame-rate sensor |
| Auto-focus | Real-time autofocus without focus beads |
| Magnification Switching | Tool-free, RFID-recognized modular objectives |
| Compliance | USP <788>, USP <789>, Ph. Eur. 2.9.19, ISO 14644-1, FDA 21 CFR Part 11, GLP/GMP-ready |
| Software | SMILLA View v5.x with audit trail, electronic signatures, LIMS integration via ASTM E1384 / LADS framework |
| Cleaning | Fully automated post-run rinse and backflush cycle |
| Pump Configurations | MACRO (peristaltic), MICRO1 (single syringe), MICRO2 (dual alternating syringe), HYBRID (peristaltic + syringe) |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PLD-601 |
| Detection Principle | Light Obscuration (LO) / Single-Particle Optical Sizing (SPOS) |
| Laser Source | Dual-narrow-beam laser diode array (8th-generation) |
| Sensor Resolution | 1000 channels, down to 0.01 µm |
| Flow Control | Precision metering piston pump + ultra-precise electromagnetic flow regulation |
| Sample Volume Accuracy | < ±1% |
| Counting Accuracy | ±3% typical (per ChP 2020 & USP <788>) |
| Coincidence Limit | ≤2.5% at 1000 particles/mL |
| Channel Flexibility | User-definable size bins (e.g., 4–70 µm(c), 1–100 µm, or 0.1 µm(c)) |
| Flow Rate Range | Sample: 5–150 mL/min |
| Rinse | 5–500 mL/min |
| Fluid Temperature Range | 0–80 °C |
| Ambient Operating Range | −15–50 °C |
| Compliance | ChP 2020 <0903>, USP <788>/<789>/<797>, EP 10.0, BP 2019, JP 17, ISO 21501-4, ISO 11171, GB/T 11446.9–2013, YBB00272004–2015, GB 8368 |
| Software | V8.9 Analytical Suite (PC & embedded touchscreen), FDA 21 CFR Part 11 compliant (audit trail, electronic signature, role-based 5-level access, data backup/restore, power-fail recovery) |
| Calibration Standards | NIST-traceable polystyrene latex (PSL) spheres, JJG 1061–2019, ISO 21501-4 |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PLD-601* |
| Sensor | 8th-generation dual-laser narrow-beam particle sensor |
| Detection Principle | Light Blockage (Optical Obstruction) |
| Measurement Range | 1–500 µm (optional 0.03–3000 µm) |
| Channel Count | 1000 adjustable channels (down to 0.01 µm resolution) |
| Sampling Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Sample Temperature Range | 0–80 °C |
| Accuracy | ±3% typical (per ChP 2020 & USP <788>) |
| Coincidence Limit | ≤2.5% at 1000 particles/mL |
| Resolution | >95% (ChP-calibrated), <10% (USP/ISO 21501-calibrated) |
| Compliance | ChP 2020 <0903>, USP <788>/<789>/<797>, EP 10.0, BP 2019, JP 17, ISO 21501-4, ISO 11171, GB/T 11446.9-2013, GB 8368, YBB 00272004-2015 |
| Software | V8.9 Regulatory Edition with 5-level user permissions, audit trail, electronic signature, 21 CFR Part 11 compliance, data backup/recovery, and power-fail protection |
| Interface | Touchscreen + optional wireless keyboard/mouse |
| Calibration Standards | JJG 1061, NIST-traceable latex spheres, or ISO 21501-4 reference materials |
| Brand | Tianhe |
|---|---|
| Origin | Tianjin, China |
| Model | GWF-6JA |
| Particle Detection Principle | Laser Light Obscuration (LO) |
| Measurement Channels | 20 µm, 15–25 µm, ≥25 µm, 25–50 µm, 51–100 µm, >100 µm |
| Sizing Range | 5–200 µm |
| Count Range | 0–65,535 particles per sample |
| Sample Volumes | 5 mL, 100 mL, 475 mL, 500 mL, or full-volume aspiration |
| Accuracy | ±10% of specified value |
| Relative Standard Deviation (RSD) | ≤2% (for standard latex particles ≥1500 particles/mL) |
| Power Supply | AC 220 V ±10%, 50 Hz, ≤45 W |
| Stirring Speed | 0–2000 rpm, paddle-type, non-contact |
| Operating Temperature | 10–40 °C |
| Dimensions | 325 × 320 × 460 mm |
| Weight | 22 kg |
| Compliance | Designed to meet Chinese Pharmacopoeia (ChP) General Chapter 0903, USP <788>, and ISO 8573-1 (particulate contamination in compressed gases—adapted for liquid-phase validation) |
| Brand | Tianhe |
|---|---|
| Origin | Tianjin, China |
| Manufacturer Type | Authorized Distributor |
| Product Category | Domestic |
| Model | GWF-7JA |
| Pricing | Available Upon Request |
| Light Source | High-Performance Laser |
| Detection Principle | Light Obscuration (LO) |
| Sample Compatibility | Colorless & Colored Clear Liquids, Organic Solvents, Oil-Based Formulations |
| Sample Volume Range | 1–6000 mL (0.1 mL incremental step) |
| Volume Accuracy | ≤ ±0.5% (2–1000 mL) |
| Syringe Options | 5 mL, 10 mL, 25 mL |
| Flow Rate | 5–160 mL/min (user-adjustable) |
| Particle Size Channels | 2–3 µm, 3–4 µm, 4–6 µm, 5–6 µm, ≥5 µm, ≥10 µm, 15–25 µm, ≥25 µm, 25–50 µm, 51–100 µm, >100 µm, 20 µm |
| Customizable Channel Range | 1–500 µm (segmented selection) |
| Count Range | 0–999,999 particles per sample |
| Counting Accuracy | < ±5% of certified reference value |
| RSD | < 1.5% (for standard particles ≥1000 counts) |
| Coincidence Error | < 5% at 10,000 particles/mL |
| Stirring Mechanism | Frictionless Propeller-Type Agitator, 0–2000 rpm (adjustable) |
| Display | Large Backlit LCD with Multi-Channel Real-Time Data & Histogram Overlay |
| Preloaded Database | >300 USP/ChP-Listed Pharmaceuticals & Medical Devices |
| Compliance | GB 8368–2018, Chinese Pharmacopoeia (2020 Edition), ISO 21501-4, USP <788>, USP <789>, EP 2.9.19 |
| Connectivity | RS232 Interface for LIMS/Lab Platform Integration |
| Power Supply | AC 220 V ±10%, 50 Hz, <100 W |
| Operating Temperature | 10–40 °C |
| Wetted Materials | 316L Stainless Steel + PTFE (for syringe, slit, and fluidic path) |
| Brand | Tianhe |
|---|---|
| Origin | Tianjin, China |
| Manufacturer Type | Authorized Distributor |
| Product Origin | Domestic (China) |
| Model | GWF-8JA |
| Pricing | Available Upon Request |
| Principle | Light Obscuration (LO) with Laser Detection |
| Compliance | Fully Aligned with Chinese Pharmacopoeia (ChP) 2020 Edition, General Chapter 0903 |
| Sample Types | Sterile Injectable Solutions, Lyophilized Powders, Concentrated Injection Solutions |
| Detection Range | 1–500 µm (Configurable Channel Segments) |
| Channel Settings | ≥2 µm, 4–6 µm, ≥5 µm, ≥8 µm, ≥10 µm, ≥12 µm, ≥25 µm, ≥100 µm |
| Count Range | 0–9,999,999 particles per sample |
| Max. Particle Concentration | <10,000 particles/mL |
| Sample Volume | 0.2–1000 mL (5 mL accuracy: ±0.5%) |
| Flow Rate | 5–80 mL/min (adjustable) |
| Measurement Accuracy | ±10% of reference value |
| Channel Resolution | >95% |
| RSD | <2% (for standard latex particles ≥1000 particles/mL) |
| Stirring Speed | 0–2000 rpm (propeller-type, frictionless, programmable) |
| Operating Temperature | 10–40 °C |
| Power Supply | AC 220 V ±10%, 50 Hz, ≤100 W |
| Display | Large LCD with Chinese GUI |
| Data Handling | Onboard storage, USB export, LAN connectivity, optional integration with LIMS or ELN platforms |
| Preloaded Drug Library | >300 ChP-listed injectables |
| Brand | Tianhe |
|---|---|
| Origin | Tianjin, China |
| Manufacturer Type | Authorized Distributor |
| Regional Classification | Domestic (PRC) |
| Model | GWF-8JD |
| Pricing | Upon Request |
| Brand | Tianhe |
|---|---|
| Origin | Tianjin, China |
| Manufacturer Type | Authorized Distributor |
| Product Category | Domestic |
| Model | GWF-8JDS |
| Pricing | Upon Request |
| Brand | Tianhe |
|---|---|
| Origin | Tianjin, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | GWF-9DW |
| Pricing | Available Upon Request |
| Brand | Tianhe |
|---|---|
| Origin | Tianjin, China |
| Manufacturer Type | Authorized Distributor |
| Product Origin | Domestic (China) |
| Model | GWF-A1 |
| Pricing | Available Upon Request |
| Brand | Tianhe |
|---|---|
| Origin | Tianjin, China |
| Manufacturer Type | Authorized Distributor |
| Region of Manufacture | Domestic (China) |
| Model | GWF-A1 |
| Pricing | Available Upon Request |
| Light Source | High-Stability Laser Diode with Optical Power Compensation Circuit |
| Sample Compatibility | Colorless & Colored Clear Liquids, Organic Solvents, Oil-Based Matrices, Weakly Acidic/Alkaline Solutions |
| Fluidic Path Materials | Imported 316L Stainless Steel & PTFE |
| Particle Size Range | 1–500 µm |
| Channel Resolution | >95% |
| Counting Accuracy | ±5% of Reference Value |
| Relative Standard Deviation (RSD) | <1.5% (for standard particles ≥1000 particles/mL) |
| Minimum Detectable Concentration | 18,000 particles/mL |
| Adjustable Sampling Volume | 0.2–1000 mL (0.1 mL resolution, accuracy <±0.5%) |
| Flow Rate Control | 5–80 mL/min (programmable) |
| Stirring Speed | 0–1000 rpm |
| Operating Temperature | 10–40 °C |
| Power Supply | 100–240 VAC, 50/60 Hz, <80 W |
| Data Interfaces | RS232, USB Storage, Thermal Printer Port |
| Software Platform | Embedded Android OS with Multi-Tier User Authentication & Audit Trail Support |
| Calibration Standards | USP <788>, USP <789>, ChP (Chinese Pharmacopoeia) Vol. IV, ISO 21510, EP 2.9.19 |
| Data Storage | Local SQLite Database with Statistical Analysis Engine |
| Compliance Features | Electronic Signature Support, User Access Logs, Data Integrity Controls per ALCOA+ Principles |
| Brand | Tianhe |
|---|---|
| Origin | Tianjin, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | GWF-A2 |
| Pricing | Available Upon Request |