Insoluble Particle Detector
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| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | PST-890 |
| Price | USD 53,200 (approx. ¥380,000) |
| Sensor Generation | 8th-Gen Dual-Laser Narrow-Beam Detector |
| Detection Principle | Light Obscuration (LO) / Single-Particle Optical Sizing (SPOS) |
| Calibration Standards | ISO 21501-4, JJG 1061, NIST-Traceable Latex Spheres |
| Software | V8.9 Integrated Particle Analysis Suite (PC & Embedded Touch UI) |
| Sample Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Temperature Range (Fluid) | 0–80 °C |
| Environmental Operating Range | −15–50 °C |
| Counting Channels | 1000 configurable channels (user-definable from 4 to 128 size bins) |
| Detection Range | 1–450 µm (extended range 0.03–3000 µm optional) |
| Custom Ranges | 1–100 µm, 4–70 µm(c), 0.1 µm(c) |
| Sampling Accuracy | <±1% |
| Coincidence Limit | 1000 particles/mL (2.5% coincidence error) |
| Resolution | >95% (per ChP 2015/2020), <10% (per USP <788>, ISO 21501-4) |
| Compliance | GB/T 11446.9–2013, ChP 0903, USP <788>/<789>/<797>, EP 10.0/9.0/8.0, BP 2019/2018, JP 17/16/15, IP 2015, WHO IntPh IV, YBB 00272004–2015, GB 8368, ISO 21510, ISO 11171, NAS 1638, ISO 4406, SAE AS4059, MIL-STD-1246C, JIS B 9933, IP 564/565, ROC T 17216, GB/T 14039, DL/T 432, DL/T 1096, JB/T 9737, GJB/T 420A/B, GB/T 18854 |
| Brand | PULUODY |
|---|---|
| Model | PST-890 |
| Detection Principle | Light Obscuration (LO) with Dual-Laser Narrow-Beam Sensor |
| Particle Size Range | 1–450 µm (optional extended to 0.03–3000 µm) |
| Resolution | >95% (ChP 2015/2020 calibrated), <10% (USP/ISO 21501 calibrated) |
| Channel Count | 1000 adjustable channels (customizable from 4 to 128 size bins) |
| Flow Control | Precision metering piston pump + ultra-precise electromagnetic flow regulation |
| Sampling Accuracy | <±1% |
| Counting Accuracy | ±3% typical |
| Coincidence Limit | ≤2.5% error at 1000 particles/mL |
| Operating Temperature | Fluid 0–80 °C, Ambient –15–50 °C |
| Compliance | USP <788>, <789>, <797> |
| Brand | PULUODY |
|---|---|
| Model | PST-890 |
| Sensor Technology | 8th-Generation Dual-Laser Narrow-Beam Light Obscuration |
| Detection Range | 1–450 µm (optional 0.03–3000 µm) |
| Channel Count | 1000 adjustable channels (down to 4-channel user-defined bins) |
| Sample Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Accuracy | ±3% typical (per ChP 2020 & USP <788>) |
| Coincidence Limit | ≤2.5% at 1000 particles/mL |
| Resolution | >95% (ChP-calibrated), <10% (ISO 21501-calibrated) |
| Temperature Range (fluid) | 0–80 °C |
| Compliance | FDA 21 CFR Part 11, ASTM D6786, ISO 21501-4, ISO 11171, USP <788>/<789>, EP 10.0, ChP 0903, GB/T 11446.9-2013, YBB00272004-2015, GB 8368 |
| Software | V8.9 Regulatory-Compliant Particle Analysis Suite with Audit Trail, e-Signature, and 5-Tier User Permissions |
| Calibration Standards | NIST-traceable latex spheres, JJG 1061, or ISO 21501-4 reference materials |
| Sample Compatibility | Aqueous & non-aqueous parenterals, lipid emulsions, lyophilized powders (reconstituted), ophthalmic solutions, vaccines, WFI, medical packaging extracts, infusion sets, filter challenge fluids |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PST-890SIS |
| Detection Principle | Light Obscuration (LO) with Dual-Laser Narrow-Beam Sensor |
| Particle Size Range | 1–450 µm (optional extension to 0.03–3000 µm) |
| Channel Resolution | 1000 adjustable channels (down to 0.01 µm bin width) |
| Sampling Accuracy | < ±1% |
| Measurement Accuracy | < ±3% (typical) |
| Coincidence Limit | ≤2.5% error at 1000 particles/mL |
| Resolution Compliance | >95% per ChP 2015/2020 |
| Flow Rate (Sampling) | 5–150 mL/min |
| Flow Rate (Rinse) | 5–500 mL/min |
| Fluid Temperature Range | 0–80 °C |
| Ambient Operating Temperature | −15–50 °C |
| Software | V8.9 Integrated Analysis Suite with 21 CFR Part 11 Compliance |
| Regulatory Alignment | ChP 0903, USP <788>/<789>/<797>, EP 10.0/9.0, BP 2019, JP 17, ISO 21510, ISO 11171, NAS 1638, ASTM D6786, GB/T 11446.9–2013, YBB00272004–2015, GB 8368 |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PST-890SIS |
| Sensor | 8th-Generation Dual-Laser Narrow-Beam Particle Sensor |
| Detection Range | 1–450 µm (optional 0.03–3000 µm) |
| Resolution | >95% (per ChP 2015/2020), <10% (per USP/ISO 21501) |
| Channel Count | 1000 adjustable channels (configurable from 4 to 128 size bins) |
| Sampling Flow Rate | 5–150 mL/min |
| Cleaning Flow Rate | 5–500 mL/min |
| Temperature Range (Fluid) | 0–80 °C |
| Accuracy | ±3% typical |
| Sampling Precision | <±1% |
| Coincidence Limit | ≤2.5% at 1000 particles/mL |
| Compliance | USP <788>, <789>, <797> |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PST-890SIS |
| Detection Principle | Light Obscuration (LO) with Dual-Laser Narrow-Beam Sensor |
| Particle Size Range | 1–450 µm (optional 0.03–3000 µm) |
| Channel Count | 1000 adjustable channels (down to 4-channel custom binning) |
| Sample Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| 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) |
| Temperature Range (Fluid) | 0–80 °C |
| Compliance | FDA 21 CFR Part 11, GLP/GMP-ready, Audit Trail, Electronic Signature, 5-Tier User Permission Architecture |
| Software | V8.9 Particle Analysis Suite (PC + embedded touchscreen) |
| Calibration Standards | ISO 21501-4, JJG 1061, NIST-traceable latex spheres |
| Regulatory Alignment | ChP 0903 (2015/2020), USP <788>/<789>/<797>, EP 10.0, BP 2019, JP 17, ISO 21510, ISO 11171, NAS 1638, ISO 4406 |
| 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 |