Insoluble Particle Detector
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| Brand | Particle Sizing Systems (PSS), USA |
|---|---|
| Origin | USA |
| Model | AccuSizer 780 A9000 FXnano-SIS |
| Detection Principle | Focused Light Obscuration (FLO) & Single Particle Optical Sensing (SPOS) |
| Size Range | 0.15 µm – 400 µm |
| Lower Detection Limit | 0.15 µm (FXnano sensor) |
| Upper Concentration Limit | 1 × 10⁶ particles/mL (FXnano) |
| Channel Resolution | 512 channels |
| Compliance | ASTM F2863, USP <788>, <789>, <1788>, ISO 21501-4, FDA 21 CFR Part 11 ready |
| 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 | Particle Sizing Systems (PSS) |
|---|---|
| Origin | USA |
| Model | AccuSizer 780 A2000 SIS |
| Detection Principle | Single Particle Optical Sensing (SPOS) with Light Obscuration (LO) and Enhanced Light Scattering (LS) |
| Size Range | 0.5 µm – 400 µm |
| Compliance | USP <787>, <788>, <789>, <1788>, Ch.P, EP, JP |
| Automation | Fully automated sampling, analysis, data processing, and system cleaning |
| Brand | PSS (Particle Sizing Systems) |
|---|---|
| Origin | USA |
| Model | AccuSizer 780 A7000 AD |
| Detection Principle | Single Particle Optical Sensing (SPOS) |
| Measurement Range | 0.5 µm – 400 µm |
| Sensor Type | LE Series (Light Obscuration + Light Scattering) |
| Channel Resolution | 512 channels |
| Maximum Sample Concentration | 1 × 10⁹ particles/mL |
| Particle Sensitivity | ≤10 ppt (parts per trillion, by volume) |
| Automation Features | Auto-dilution, auto-sampling, auto-cleaning, auto-calibration |
| Compliance Context | Designed for USP <788>, USP <789>, ISO 21501-4, ISO 13322-2, and FDA 21 CFR Part 11–ready data integrity workflows |
| Brand | Particle Sizing Systems (PSS) |
|---|---|
| Origin | USA |
| Model | AccuSizer 780 A7000 APS |
| Detection Principle | Single Particle Optical Sensing (SPOS) |
| Size Range | 0.5 µm – 400 µm |
| Resolution | 512-channel |
| Max Sample Concentration | 10¹¹ particles/mL |
| Compliance | USP <729>, ChP 2015, 21 CFR Part 11, cGMP |
| Automation | Integrated auto-sampling, two-step auto-dilution, auto-detection, data processing, and auto-cleaning |
| Brand | PULUODY |
|---|---|
| Model | PLD-6001 |
| Origin | Shaanxi, China |
| Sensor Technology | 8th-Generation Dual-Laser Narrow-Beam Light Obscuration |
| Detection Range | 1–500 µm (optional 0.03–3000 µm) |
| Resolution | >95% (ChP 2015/2020 calibrated) |
| Channel Count | 1000 adjustable channels (user-definable from 4 to 128 size bins) |
| Flow Control | Precision metering piston pump + ultra-precise electromagnetic flow regulation |
| Sampling Accuracy | <±1% |
| Measurement Accuracy | <±3% (typical) |
| Coincidence Limit | ≤2.5% at 1000 particles/mL |
| Sample Temperature Range | 0–80 °C |
| Environmental Operating Range | −15–50 °C |
| Compliance | ChP 2020 Appendix 0903, USP <788>, <789>, <797>, EP 10.0, BP 2019, JP 17, ISO 21501-4, ISO 21510, GB/T 11446.9–2013, GB 8368, YBB 00272004–2015 |
| Software | V8.9 Particle Analysis Suite (PC & embedded touchscreen), 21 CFR Part 11 compliant with audit trail, electronic signature, role-based 5-level access control, data backup/recovery, and power-fail protection |
| Calibration Standards | JJG 1061, NIST-traceable latex spheres, ISO 21501-4 |
| 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 |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | PLD-601 |
| Price | USD 26,500 (FOB) |
| Detection Principle | Light Obscuration (LO) with Dual-Laser Narrow-Beam Sensor |
| Particle Size Range | 1–500 µm (optional 0.03–3000 µm) |
| Channel Count | 1000 customizable channels (down to 0.01 µm resolution) |
| Flow Accuracy | < ±1% |
| Volumetric Precision | < ±3% (typical) |
| Coincidence Limit | ≤2.5% at 1000 particles/mL |
| Resolution | >95% (CP 2015/2020 calibration), <10% (USP/ISO 21501 calibration) |
| Sample Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Fluid Temperature Range | 0–80 °C |
| Ambient Operating Temperature | −15–50 °C |
| Compliance | CP 2020 Method 0903, GB 8368, USP <788>, <789>, <797>, EP 10.0, BP 2019, JP 17, ISO 21501-2, ISO 11171, ASTM D6786, FDA 21 CFR Part 11 (audit trail, e-signature, role-based 5-level access) |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Manufacturer Type | Authorized Distributor |
| Product Origin | Domestic (China) |
| Model | PLD-601 |
| Price | USD 29,500 (approx.) |
| Detection Principle | Light Obscuration (LO) / Dual-Laser Narrow-Beam Particle Sensing |
| Sensor Generation | 8th-Generation Dual-Laser Optical Sensor |
| Flow Control | Precision Metering Plunger Pump + Ultra-Precise Electromagnetic Flow Control System |
| Calibration Standards | JJG 1061, ISO 21501-4, NIST-Traceable Latex Spheres |
| Regulatory Compliance | ChP 2020 <0903>, USP <788>/<789>, EP 10.0, BP 2019, JP 17, WHO IntPh IV, YBB00272004-2015, GB/T 11446.9-2013, ISO 21510, ISO 11171 |
| Software | V8.9 Regulatory-Grade Analysis Suite (FDA 21 CFR Part 11 Compliant) |
| Particle Size Range | 1–500 µm (optional extended range: 0.03–3000 µm) |
| Channel Resolution | 1000-user-definable channels (min. bin width: 0.01 µm) |
| Sample Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Temperature Range (Fluid) | 0–80 °C |
| Accuracy | ±3% typical (per ChP 2020) |
| Coincidence Limit | ≤2.5% at 1000 particles/mL |
| Resolution | >95% (ChP-calibrated), >90% (ISO 21501-4 calibrated) |
| Data Integrity | Audit Trail, Electronic Signature, Role-Based 5-Tier User Permissions, Auto-Backup/Restore, Power-Fail Recovery |
| Interface | Color LCD Touchscreen + Optional Wireless Keyboard/Mouse |
| Sample Compatibility | Aqueous & non-aqueous sterile injectables, lyophilized powders, ophthalmic solutions, vaccines, WFI, pharmaceutical packaging materials, infusion devices, terminal filters, CMP slurries, ultrapure water, electronic-grade chemicals |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | PLD-601 |
| Price | USD 32,500 (FOB) |
| Detection Principle | Light Obscuration (LO) / Dual-Laser Narrow-Beam Particle Sensing |
| Sensor Generation | 8th-Generation Dual-Laser Optical Sensor |
| Flow Control | Precision Metering Plunger Pump + Ultra-Precise Electromagnetic Flow Regulation |
| Software | V8.9 Regulatory-Compliant Analysis Suite (PC & Touchscreen) |
| Calibration Standards | JJG1061, ISO 21501-4, NIST-Traceable Latex Spheres |
| Regulatory Alignment | ChP 2020 <0903>, USP <788>/<789>/<797>, EP 10.0, BP 2019, JP 17, ISO 21510, GB/T 11446.9-2013, GB 8368 |
| Particle Size Range | 1–500 µm (optional extension: 0.03–3000 µm) |
| Channel Count | 1000 adjustable channels (user-definable from 4 to 128 size bins) |
| Sample Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Temperature Range (Fluid) | 0–80 °C |
| Accuracy | ±3% typical (per ChP 2020) |
| Resolution | >95% (ChP-calibrated), >90% (ISO 21501-4 calibrated) |
| Coincidence Limit | ≤2.5% at 1000 particles/mL |
| Sampling Precision | <±1% volumetric repeatability |
| Data Integrity | 5-Tier User Permission Architecture, Audit Trail, Electronic Signature, Full 21 CFR Part 11 Compliance, Auto-Backup/Restore, Power-Fail Recovery |
| 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 | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PLD-601 |
| Detection Principle | Light Obscuration (LO) with Dual-Laser Narrow-Beam Sensor |
| Measurement Range | 1–500 µm (optional 0.03–3000 µm) |
| Channel Resolution | 1000 customizable channels (down to 0.01 µm bin width) |
| 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 |
| Temperature Range (Fluid) | 0–80 °C |
| Compliance | ChP 2020 <0903>, USP <788>/<789>/<797>, EP 10.0, BP 2019, JP 17, ISO 21501-2, ISO 11171, GB/T 11446.9–2013, GB 8368, FDA 21 CFR Part 11 (audit trail, e-signature, role-based 5-level access), GLP/GMP-ready software architecture |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Manufacturer Type | Authorized Distributor |
| Product Origin | Domestic (China) |
| Model | PLD-601 |
| Price | USD 34,500 (FOB Shanghai, ex-factory) |
| Detection Principle | Light Obscuration (LO) / Single-Particle Optical Sizing (SPOS) |
| Sensor Generation | 8th-Generation Dual-Laser Narrow-Beam Particle Sensor |
| Flow Control | Precision Metering Plunger Pump + Ultra-Precise Electromagnetic Flow Control System |
| Software Compliance | FDA 21 CFR Part 11, ALCOA+ Data Integrity, Audit Trail, Electronic Signature, 5-Level User Permission Management |
| Calibration Standards | ISO 21501-4, JJG 1061, NIST-Traceable Latex Standards |
| Detection Range | 1–500 µm (optional 0.03–3000 µm) |
| Channel Count | 1000 High-Resolution Channels (0.01 µm resolution increment) |
| Sample Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Temperature Range | Fluid 0–80 °C |
| Accuracy | ±3% typical (per ChP 2020 & USP <788>) |
| Repeatability | ≤2.5% coincidence error at 1000 particles/mL |
| Resolution | >95% (ChP-calibrated) |
| Regulatory Alignment | ChP 2020 <0903>, USP <788>, <789>, <797>, EP 10.0, BP 2019, JP 17, WHO IntPh IV, YBB00272004-2015, GB/T 11446.9-2013, ISO 21510, ISO 4406, NAS 1638, ASTM D6786 |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PLD-601 |
| Detection Principle | Light Obscuration (LO) / Single-Particle Optical Sizing (SPOS) |
| Sensor Generation | 8th-Generation Dual-Laser Narrow-Beam Particle Sensor |
| Flow Control | Precision Metering Plunger Pump + Ultra-Precise Electromagnetic Flow Control System |
| Measurement Range | 1–500 µm (optional 0.03–3000 µm) |
| Resolution | >95% (ChP 2015/2020 calibrated) |
| Channel Count | 1000 user-definable channels (down to 0.01 µm bin resolution) |
| Sampling Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Sample Temperature Range | 0–80 °C |
| Accuracy | ±3% typical (particle count), ±1% volumetric delivery |
| Coincidence Limit | ≤2.5% at 1000 particles/mL |
| Compliance | ChP 2020 <0903>, USP <788>, <789>, <797>, EP 10.0, BP 2019, JP 17, ISO 21501-4, GB/T 11446.9–2013, GB 8368, YBB 00272004–2015, FDA 21 CFR Part 11 (audit trail, e-signature, role-based 5-level access, data backup/recovery, power-fail protection) |
| Software | PULUODY V8.9 PC & Integrated Touchscreen Edition |
| Interface | Bilingual (English/Chinese) GUI |
| Calibration Standards | NIST-traceable latex spheres, ISO 21501-4, JJG 1061 |
| Metrology Support | Accredited by NWMS (China National Institute of Metrology Northwest Center) & DFKW Level-1 Particle Metrology Station No. 116 |
| Key | Brand: PULUODY |
|---|---|
| Model | PLD-601 |
| Origin | Shaanxi, China |
| Detection Principle | Light Obscuration (LO) with Dual-Laser Narrow-Beam Sensor |
| Measurement Range | 1–450 µm (optional extension to 0.03–3000 µm) |
| Channel Count | 1000 adjustable size channels |
| Flow Rate (Sampling) | 5–150 mL/min |
| Flow Rate (Cleaning) | 5–500 mL/min |
| Accuracy | ±5% typical (per ChP 2020 & USP <788>) |
| Resolution | >95% (ChP-calibrated), <10% RSD (USP/ISO 21501-calibrated) |
| Sample Temperature Range | 0–80 °C |
| Environmental Operating Range | 0–50 °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 PC & Embedded Analysis Suite with 21 CFR Part 11 Compliance (Audit Trail, Electronic Signature, Role-Based 5-Tier Access, Data Backup/Restore, Power-Fail Recovery) |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Manufacturer Type | Authorized Distributor |
| Product Origin | Domestic (China) |
| Model | PLD-601 |
| Pricing | Upon Request |
| Sensor Technology | 8th-Generation Dual-Laser Narrow-Beam Particle Sensor |
| Flow Control | Precision Metering Plunger Pump + Ultra-Precise Electromagnetic Flow Control System |
| Software | V8.9 Integrated Analysis Software (PC & Touchscreen) |
| Compliance | ChP 2020 <0903>, USP <788>/<789>/<797>, EP 10/9.0/8.0, BP 2019, JP 17, ISO 21501, ISO 11171, GB/T 11446.9–2013, YBB 00272004–2015, GB 8368 |
| Detection Range | 1–500 µm (optional 0.03–3000 µm) |
| Channel Count | 1000 user-definable channels (min. 4, max. 1000) |
| Resolution | >95% (ChP-calibrated), <10% (USP/ISO-calibrated) |
| Sampling Accuracy | <±1% |
| Measurement Accuracy | ±3% typical |
| Coincidence Limit | 1000 particles/mL (2.5% coincidence error) |
| Sample Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Fluid Temp. Range | 0–80 °C |
| Ambient Temp. Range | −15–50 °C |
| Calibration Standards | JJG 1061, ISO 21501, NIST-traceable latex spheres |
| Data Integrity | FDA 21 CFR Part 11 compliant (audit trail, electronic signature, role-based 5-level access, backup/restore, power-fail recovery) |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | PLD-601 |
| Price | USD 23,500 (approx.) |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China (Manufactured in China) |
| Manufacturer Type | Direct Manufacturer |
| Model | PLD-601-B |
| Price | USD 29,500 (approx.) |
| Detection Principle | Light Obscuration (LO) |
| Calibration Standards | USP <788>, USP <789>, EP 2.9.19, JP 6.04, ChP 2015 Vol I Appendix IX R |
| Measurement Range | 0.03 µm – 3000 µm (configurable sub-ranges) |
| Channel Count | 1000 adjustable size channels |
| Sample Volume | 1 mL to unlimited (programmable) |
| Flow Accuracy | ±1% |
| Counting Accuracy | ±3% typical |
| Coincidence Limit | ≤3% at 40,000 particles/mL |
| Resolution | ≥95% (ChP 2015), <10% (USP <788>, ISO 21501-4, JJG 1061) |
| Viscosity Range | 0–99 mm²/s (pressurized up to 500 mm²/s) |
| Flow Rate | 5–150 mL/min (sampling), 5–500 mL/min (flushing) |
| Temperature Range | Fluid 0–80 °C |
| Data Storage | ≥20,000 test records (expandable via USB) |
| Compliance | FDA 21 CFR Part 11 ready (audit trail & electronic signature optional), GLP/GMP traceable operation |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Manufacturer Type | Authorized Distributor |
| Product Origin | Domestic (China) |
| Model | PLD-MPCS2.0 |
| Price | USD 51,200 (FOB China) |
| Compliance | ChP 2020 Appendix 0903 Method 2 (Microscopic Particle Counting), USP <788>, USP <789>, EP 8.0, ISO 21501-4, ISO 21510, GB/T 11446.9-2013 |
| Measurement Principle | Bright-field Microscopy + Digital Image Analysis |
| Particle Detection Range | 1–500 µm |
| Magnification | 40×–1000× |
| Resolution | 0.1 µm |
| Repeatability Error | <5% (excluding sample preparation variability) |
| CCD Sensor | 3 MP monochrome digital camera |
| Calibration Traceability | Northwest Metrology & Testing Center (Civil Products) |
| Software Platform | Windows XP/7/10 (32/64-bit), RS232/USB interface |
| Image Processing Speed | <1 sec per frame segmentation |
| Segmentation Success Rate | >93% |
| Accuracy | ±3% typical (ChP 2020 reference), >95% resolution (ChP 2020), <10% misclassification rate (USP/ISO 21501-4) |
| Reporting | ASTM E2457-compliant output, GLP audit trail enabled, FDA 21 CFR Part 11 optional module available |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PLD-MPCS2.0 |
| Magnification Range | 40×–1000× |
| Resolution | 0.1 µm |
| Measurement Range | 1–500 µm |
| Repeatability Error | <5% |
| Accuracy | ±3% (typical) |
| Particle Segmentation Speed | <1 s |
| Segmentation Success Rate | >93% |
| Brand | PULUODY |
|---|---|
| Model | PLD-MPCS2.0 |
| Origin | Shaanxi, China |
| Microscope Magnification | 40×–1000× |
| Measurement Range | 1–500 µm |
| Resolution | 0.1 µm |
| Repeatability Error | <5% |
| CCD Camera | 3 MP |
| Particle Segmentation Speed | <1 s |
| Segmentation Success Rate | >93% |
| Accuracy | ±3% (typical) |
| Coincidence Limit | 10,000 particles/mL (5% coincidence error) |
| Resolution Compliance | >95% (ChP 2020), <10% (USP <788>, ISO 21501) |
| Interface | RS232 or USB |
| Software Platform | Windows 2000/XP |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Manufacturer Type | Direct Manufacturer |
| Origin Category | Domestic (China) |
| Model | PLD-MPCS2.0A |
| Price | USD 42,000 (approx.) |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PSD-PF100-1A-0.5 |
| Dimensions | 360 × 450 × 580 mm |
| Cleanroom Class | ISO Class 4 (10-class) & ISO Class 5 (100-class) |
| Air Velocity | 0.25 m/s |
| Vibration Amplitude | ≤3 µm |
| Noise Level | ≤67 dB(A) |
| Lighting | Fluorescent Lamp |
| Sterilization | UV-C Lamp (254 nm) |
| Operating Temperature | 10–30 °C |
| Relative Humidity | ≤75% RH |
| Power Supply | AC 220 V ±10%, 50 Hz ±1 Hz |
| Construction | Powder-coated steel frame with 304 stainless steel work surface |
| Optional Accessories | High-purity nitrogen inlet with inline filter, articulated nitrogen delivery hose, motorized bidirectional sample rotation stage |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PSD-PF10A-0.5 |
| Cleanliness Class | ISO Class 4 (10 particles ≥0.1 µm per cubic foot) |
| Airflow Velocity | 0.25–0.6 m/s (adjustable) |
| Vibration Amplitude | ≤3 µm |
| Operating Noise | ≤67 dB(A) |
| UV Sterilization Time | 15 min for microbiological decontamination |
| Power Supply | AC 220 V ±10%, 50 Hz ±1 Hz |
| Ambient Temp. | 10–30 °C, RH ≤75%, low-vibration, low-dust environment |
| Construction | Fully welded steel frame with epoxy powder coating, 304 stainless steel work surface |
