PULUODY
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| 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 |
| Manufacturer Type | Authorized Distributor |
| Product Category | Domestic |
| Model | PLD-601 |
| Price | USD 35,200 (FOB) |
| Dispersion Method | Wet Dispersion |
| Instrument Type | Benchtop Laboratory Laser Particle Counter |
| Measurement Range | 1–500 µm (0.03–3000 µm available upon configuration) |
| Repeatability | ≤2.5% coincidence error at 1000 particles/mL |
| Measurement Time | ≤60 seconds per sample |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | PLD-601-1 |
| Instrument Type | Optical Particle Counter |
| Sensor Generation | 8th-Generation Dual-Laser Narrow-Beam Detector |
| Software Version | V8.9 Integrated PC-Based Analysis Software |
| Compliance Standards | Chinese Pharmacopoeia 2015 & 2020, USP <788> & <789>, EP 2.9.19, BP, GB 8368 |
| Calibration Traceability | JJG 1061, ISO 21501-4, NIST-Traceable Latex Standards |
| Detection Range | 1–450 µm (extended range 0.03–3000 µm optional) |
| Custom Channel Configurations | 4, 6, 8, 16, 32, 64, or 128 user-defined size bins |
| Sampling Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Sample Temperature Range | 0–80 °C |
| Ambient Operating Temperature | −15–50 °C |
| Sampling Accuracy | < ±1% |
| Coincidence Limit | ≤2.5% error at 1000 particles/mL |
| Resolution | >95% (per ChP 2015/2020), <10% (per USP/ISO 21501-4) |
| Display Interface | Color LCD touchscreen + optional wireless keyboard/mouse |
| 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-601-D |
| Price | USD 26,500 (FOB) |
| Sensor Generation | 8th-generation dual-laser narrow-beam particle sensor |
| Flow Control | Precision metering piston pump + ultra-precise electromagnetic flow control system |
| Detection Range | 0.01 µm to 450 µm (customizable sub-ranges: e.g., 1–100 µm, 4–70 µm(c), or 0.1 µm(c)) |
| Channel Count | 1000 user-definable size channels |
| Sampling Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Sample Temperature Range | 0–80 °C |
| Ambient Operating Temperature | 0–50 °C |
| Accuracy | ±5% typical (per USP <788>, ISO 21501) |
| Coincidence Limit | ≤5% error at 1000 particles/mL |
| Resolution | >95% (ChP 2015/2020 calibrated) |
| Compliance | FDA 21 CFR Part 11 (audit trail, electronic signature, role-based 5-level access, data backup/recovery, power-fail protection) |
| Software | V8.9 Particulate Analysis Suite (PC + embedded touchscreen) |
| Calibration Standards | JJG 1061, ISO 21501, NIST-traceable latex spheres |
| Regulatory Alignment | ChP 0903, USP <788>/<789>/<797>, EP 10.0/9.0/8.0, BP 2019, JP 17, IP 2015, WHO IntPh IV, YBB00272004-2015, GB/T 11446.9-2013, ISO 4406, NAS 1638, ISO 11171, MIL-STD-1246, SAE AS749D |
| Metrology Support | Accredited by NW National Metrology Center (CNAS) and Defense Science & Technology Commission Particle Metrology Station No. 116 |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Manufacturer Type | Authorized Distributor |
| Product Category | Domestic |
| Model | PLD-601-N |
| Instrument Type | Optical Particle Counter |
| Detection Principle | Light Obscuration (LO) / Dual-Laser Narrow-Beam Sensor |
| Channel Resolution | 1000 Channels |
| Minimum Detectable Size | 0.01 µm |
| Calibration Standards | ISO 21501-4, JJG 1061, USP <788>, ChP 2020 <0903>, EP 10.0, ISO 11171 |
| Flow Control | Precision Metering Plunger Pump + Ultra-Precise Electromagnetic Flow Regulation |
| Software Compliance | FDA 21 CFR Part 11, Audit Trail, Electronic Signature, 5-Tier User Permissions |
| Operating Temperature Range | 0–80 °C (fluid), 0–50 °C (ambient) |
| Sample Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Accuracy | ±5% typical |
| Sampling Precision | <±1% |
| Coincidence Limit | 1000 particles/mL (5% coincidence error) |
| Resolution | >95% (per ChP 2015/2020), <10% (per USP/ISO 21501) |
| Customizable Size Ranges | 1–100 µm, 4–70 µm(c), 0.1 µm(c), or user-defined thresholds |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Manufacturer Type | Authorized Distributor |
| Regional Classification | Domestic (China) |
| Model | PLD-601-X |
| Price | USD 26,500 (FOB) |
| Dispersion Method | Wet Dispersion |
| Instrument Type | Laboratory Laser-Based Light Obscuration Particle Counter |
| Measurement Range | 1–450 µm |
| Repeatability | ≤5% RSD |
| Measurement Time | 5–60 seconds per sample |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Manufacturer Type | Authorized Distributor |
| Product Category | Domestic |
| Model | PLD-601-Y |
| Instrument Type | Optical Particle Counter (Light Obscuration Principle) |
| Detection Range | 1–450 µm (extendable to 0.03–3000 µm with optional configuration) |
| Sensor | 8th-Generation Dual-Laser Narrow-Beam Particle Sensor |
| Flow Control | Precision Metering Plunger Pump + Ultra-Precise Electromagnetic Flow Control System |
| Sampling Rate | 5–150 mL/min |
| Cleaning Flow Rate | 5–500 mL/min |
| Temperature Range (Fluid) | 0–80 °C |
| Ambient Operating Temperature | −15–50 °C |
| Channel Resolution | 1000 adjustable channels (down to 0.01 µm resolution) |
| Accuracy | ±5% typical (per ChP 2020 & USP <788>) |
| Coincidence Limit | ≤2.5% error at 1000 particles/mL |
| Resolution Compliance | >95% (ChP), <10% (USP/ISO 21501) |
| Calibration Standards | JJG 1061, ISO 21501, NIST-traceable latex spheres |
| Software | V8.9 Integrated Analysis Suite (PC & touchscreen), 5-level user permission, audit trail, electronic signature, 21 CFR Part 11 compliance |
| Regulatory Alignment | ChP 2015/2020 <0903>, USP <788>/<789>/<797>, EP 10.0/9.0, BP 2019, JP 17, WHO IntPh IV, YBB00272004-2015, GB/T 11446.9-2013, ISO 4406, ISO 11171, NAS 1638, MIL-STD-1246C |
| Brand | PULUODY |
|---|---|
| Model | PLD-6010 |
| Origin | Shaanxi, China |
| Detection Principle | Light Obscuration (LO) / Dual-Laser Narrow-Beam Particle Counting |
| Sensor Generation | 8th-Generation 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) |
| Flow Control | Precision metering piston pump + ultra-precise electromagnetic flow control system |
| 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 |
| Environmental Operating Temp | −15–50 °C |
| Compliance | FDA 21 CFR Part 11 (audit trail, e-signature, 5-level user权限, data backup/recovery, power-fail protection), GLP/GMP-ready |
| Calibration Standards | JJG 1061, ISO 21501-4, NIST-traceable latex spheres |
| Regulatory Alignment | ChP 2015/2020 <0903>, USP <788>/<789>/<797>, EP 10.0/9.0, BP 2019, JP 17, WHO IntPh IV, YBB 00272004-2015, GB 8368, ISO 21510, ISO 11171, NAS 1638, ISO 4406, ASTM D6786 |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PLD-601C |
| Instrument Type | Optical Liquid Particle Counter |
| Detection Principle | Light Obscuration (LO) / Dual-Laser Narrow-Beam Sensor |
| Measurement Range | 1–450 µm (optional 0.03–3000 µm) |
| Channel Count | 1000 adjustable channels |
| Flow Control | Precision Metering Piston Pump + High-Accuracy Electromagnetic Flow Regulation |
| Calibration Standards | ISO 21501-4, USP <788>, EP 2.9.19, ChP 0903, GB/T 11446.9-2013, ISO 11171, JJG 1061 |
| Software Compliance | FDA 21 CFR Part 11, Audit Trail, Electronic Signature, 5-Level User Permission Management |
| Sample Compatibility | Aqueous & non-aqueous sterile solutions, lyophilized powders, ophthalmic preparations, vaccines, WFI, medical packaging, infusion devices, CMP slurries, ultrapure water |
| Operating Temperature | 0–80 °C (fluid), 0–50 °C (ambient) |
| Sampling Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Accuracy | ±5% typical (per ChP/USP), ±1% volumetric precision |
| Coincidence Limit | ≤5% at 1000 particles/mL |
| Resolution | >95% (ChP-aligned), <10% (ISO 21501/USP-aligned) |
| Brand | PULUODY |
|---|---|
| Model | PLD-601D |
| Instrument Type | Optical Particle Counter (Light Obscuration Method) |
| Detection Principle | Dual-Laser Narrow-Beam Light Obscuration |
| Sensor Generation | 8th-Generation Dual-Laser Sensor |
| Channel Count | 1000 Adjustable Channels |
| Minimum Detectable Size | 0.01 µm (c) |
| Measurement Range | 1–450 µm |
| Sample Flow Rate | 5–150 mL/min |
| Accuracy | ±5% typical |
| Sampling Precision | <±1% |
| Coincidence Limit | 1000 particles/mL (5% coincidence error) |
| Resolution | >95% (per ChP 2015/2020), <10% (per USP/ISO 21501) |
| Compliance | USP <788>, <789>, <797> |
| Brand | PULUODY |
|---|---|
| Model | PLD-601D |
| Instrument Type | Optical Particle Counter |
| Detection Principle | Dual-Laser Narrow-Beam Light Obscuration |
| Sensor Generation | 8th-Generation Dual-Laser Sensor |
| Flow Control | Precision Metering Plunger Pump + Ultra-Precise Electromagnetic Flow Control System |
| Detection Range | 1–450 µm (customizable sub-ranges: 1–100 µm, 4–70 µm(c), or 0.1 µm(c)) |
| Channel Resolution | 1000 adjustable channels |
| Accuracy | ±5% typical |
| Sampling Precision | <±1% |
| Coincidence Limit | 1000 particles/mL (5% coincidence error) |
| Resolution | >95% (calibrated per ChP 2015/2020), <10% (per USP/ISO 21501) |
| Operating Fluid Temperature | 0–80 °C |
| Ambient Temperature | 0–50 °C |
| Compliance Standards | ChP 2015 & 2020, USP <788> & <789>, Ph. Eur. 2.9.19, BP, GB 8368, ISO 21501-4, JJG 1061 |
| Calibration Reference | NIST-traceable latex standards or ISO 21501-compliant reference materials |
| Software | V8.9 Integrated Analysis Software (PC & embedded) with 5-level user权限 management, audit trail, electronic signature, and 21 CFR Part 11 compliance |
| Display | Color LCD touchscreen + optional wireless keyboard/mouse |
| Metrology Support | Accredited calibration by NWMS (National Northwest Metrology & Testing Center) and DFSC No. 116 Station (CNSA Grade-I Particle Metrology Lab) |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PLD-601G |
| Instrument Type | Optical Light-Blockage Particle Counter |
| Detection Principle | Light Obscuration (LO) / Single-Particle Optical Sizing (SPOS) |
| Calibration Standards | ISO 21501-4, USP <788>, EP 2.9.19, ChP 2020 Edition 0903, GB/T 11446.9–2013, GB 8368 |
| Channel Resolution | 1000 user-definable channels from 0.01 µm to 450 µm (extended range up to 3000 µm optional) |
| Flow Control | Dual-precision volumetric piston pump + electromagnetic flow regulation |
| Accuracy | ±5% typical (per ChP 2020/USP <788>) |
| Sample Volume Precision | <±1% |
| Coincidence Limit | ≤2.5% error at 1000 particles/mL |
| Counting Resolution | >95% (ChP-calibrated), >90% (ISO 21501-4 calibrated) |
| Flow Rate | Sampling 5–150 mL/min |
| Fluid Temp Range | 0–80 °C |
| Operating Ambient | −15–50 °C |
| Software Compliance | FDA 21 CFR Part 11, ALCOA+ data integrity, audit trail, electronic signature, 5-level user permission management |
| Regulatory Documentation Support | GMP/GLP-compliant test reports, IQ/OQ documentation templates, traceable calibration certificates (JJG 1061, ISO 21501-4, NIST-traceable latex standards) |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PLD-601J |
| Instrument Type | Optical Light-Blockage Particle Counter |
| 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, Audit Trail, Electronic Signature, Role-Based 5-Tier User Access |
| Calibration Standards | ISO 21501-4, JJG 1061, NIST-Traceable Latex Spheres |
| Channel Resolution | 1000 Adjustable Channels (Down to 0.01 µm), Configurable Size Ranges (e.g., 1–100 µm, 4–70 µm(c), 0.1 µm(c)) |
| Measurement Range | 1–450 µm (Extended Options: 0.03–3000 µm) |
| Sample Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Temperature Range (Fluid) | 0–80 °C |
| Ambient Operating Range | −15–50 °C |
| Accuracy | ±5% typical (per ChP 2020 & USP <788>) |
| Repeatability | <2.5% coincidence error at 1000 particles/mL |
| Resolution | >95% (ChP-calibrated), >90% (ISO 21501-4 calibrated) |
| Regulatory Alignment | ChP 0903 (2015/2020), USP <788>, <789>, <797>, EP 10.0, BP 2019, JP 17, WHO IntPh IV, YBB00272004-2015, GB 8368, ISO 21510, ISO 11171, NAS 1638, ISO 4406 |
| Brand | PULUODY |
|---|---|
| Model | PLD-601jc |
| Origin | Shaanxi, China |
| Sensor Technology | 8th-generation dual-laser narrow-beam particle detection |
| Flow Control | Precision metering piston pump + ultra-precise electromagnetic flow control |
| Detection Range | 1–450 µm (optional: 0.03–3000 µm) |
| Resolution | 1000 user-definable channels down to 0.01 µm |
| Accuracy | ±5% typical (per ChP 2015/2020) |
| Counting Threshold | Customizable channel thresholds from 1–100 µm or 4–70 µm (c), including 0.1 µm (c) mode |
| Sample Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Fluid Temperature Range | 0–80 °C |
| Ambient Operating Temperature | 0–50 °C |
| Compliance | FDA 21 CFR Part 11 (audit trail, electronic signature, role-based 5-level access), GLP/GMP-ready |
| Calibration Standards | JJG1061, ISO 21501, NIST-traceable latex spheres |
| Software | PULUODY V8.9 Analysis Suite (PC & embedded touchscreen) |
| Regulatory Alignment | USP <788>, <789>, <797> |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PLD-601L |
| Instrument Type | Optical Liquid Particle Counter |
| Detection Principle | Light Obscuration (LO) / Single-Particle Optical Sizing (SPOS) |
| Sensor Generation | 8th-Generation Dual-Laser Narrow-Beam Sensor |
| Flow Control | Precision Piston Pump + Ultra-Precise Electromagnetic Flow Regulation |
| Calibration Standards | JJG1061, ISO 21501-4, USP <788>, EP 2.9.19, ChP 2020 Vol. IV <0903> |
| Particle Size Range | 1–450 µm (optional extended range: 0.03–3000 µm) |
| Channel Count | 1000 configurable size channels |
| Sampling Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Sample Temperature Range | 0–80 °C |
| Ambient Operating Temperature | −15–50 °C |
| Accuracy | ±5% typical (per ChP 2020) |
| Coincidence Limit | ≤2.5% at 1000 particles/mL |
| Resolution | >95% (ChP-calibrated), >90% (USP/EP-calibrated) |
| Compliance | ASTM F312-22, ISO 11171:2016, ISO 4406:2017, NAS 1638 Class Code, GB/T 14039–2002, YBB00272004–2015, GB 8368–2018 |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Manufacturer Type | Authorized Distributor |
| Product Category | Domestic |
| Model | PLD-601M |
| Instrument Type | Optical Particle Counter |
| Sensor | 8th-Generation Dual-Laser Narrow-Beam Particle Detection Sensor |
| Software | V8.9 Integrated Analysis & PC Software |
| Detection Principle | Light Obscuration (LO) / Single-Particle Optical Sizing (SPOS) |
| Calibration Standards | JJG1061, ISO 21501-4, USP <788>, EP 10.0, ChP 2020 <0903> |
| Measurement Range | 1–450 µm (customizable sub-ranges: 1–100 µm or 4–70 µm(c) |
| Sampling Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Sample Temperature Range | 0–80 °C |
| Ambient Operating Temperature | 0–50 °C |
| Accuracy | ±5% typical |
| Volume Precision | <±1% |
| Coincidence Limit | 1000 particles/mL (≤5% coincidence error) |
| Resolution | >95% (ChP 2015/2020 calibrated), <10% (USP/ISO 21501 calibrated) |
| Channel Count | 1000 user-definable channels (4/6/8/16/32/64/128 bin configurations supported) |
| Compliance | FDA 21 CFR Part 11 (audit trail, electronic signature, role-based 5-level access, data backup/recovery, power-fail protection), GLP/GMP-ready |
| Brand | PULUODY |
|---|---|
| Model | PLD-601MZ |
| Instrument Type | Optical Particle Counter (Light Obscuration Principle) |
| Detection Range | 1–450 µm (optional extension to 0.03–3000 µm) |
| Channel Count | 1000 customizable size channels (down to 0.01 µm resolution) |
| Flow Control | Dual-precision piston pump + ultra-precise electromagnetic flow regulation |
| Accuracy | ±2.5% typical (per ChP 2020 & USP <788>) |
| Repeatability | <2.5% coincidence error at 1000 particles/mL |
| Calibration Standards | ISO 21501-4, JJG 1061, NIST-traceable latex spheres |
| Software Compliance | FDA 21 CFR Part 11, ALCOA+ data integrity, 5-level user permission architecture, full audit trail, electronic signature, auto-backup & restore |
| Operating Temperature | 0–80 °C (fluid), 0–50 °C (ambient) |
| Sample Compatibility | Aqueous & organic solvents, sterile injectables, ophthalmic solutions, vaccines, WFI, USP-grade water, pharmaceutical packaging extracts, infusion devices, filter challenge media |
| 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, YBB 00272004-2015, GB/T 11446.9-2013 |
| Brand | PULUODY |
|---|---|
| Model | PLD-601P |
| Instrument Type | Optical Particle Counter (Light Obscuration Method) |
| Detection Principle | Dual-Laser Narrow-Beam Light Obscuration |
| Sensor Generation | 8th-Generation Dual-Laser Sensor |
| Channel Resolution | 1000 Adjustable Channels |
| Particle Size Range | 1–450 µm (optional 0.03–3000 µm) |
| Sampling Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Sample Temperature Range | 0–80 °C |
| Ambient Operating Temperature | −15–50 °C |
| Accuracy | ±5% typical |
| Sampling Precision | <±1% |
| Coincidence Limit | ≤2.5% at 1000 particles/mL |
| Resolution | >95% (Chinese Pharmacopoeia 2015/2020 calibration), <10% (USP/ISO 21501 calibration) |
| Compliance Standards | ChP 2020 <0903>, USP <788>/<789>/<797>, EP 10.0, BP 2019, JP 17, ISO 21501, ISO 11171, GB/T 11446.9–2013, GB 8368, YBB 00272004–2015 |
| Software | V8.9 Regulatory-Compliant Analysis Suite with FDA 21 CFR Part 11 Support |
| Data Integrity Features | Five-Level User Permission Management, Audit Trail, Electronic Signature, Auto Backup/Restore, Power-Fail Recovery |
| Calibration Traceability | JJG 1061, ISO 21501, NIST-Traceable Latex Standards |
| Metrology Accreditation | National Northwest Metrology & Testing Center (CNAS CALIBRATION LAB) |
| Regulatory Certification | GLP/GMP-Aligned Architecture, Validatable System Design |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Manufacturer Type | Authorized Distributor |
| Regional Category | Domestic (China) |
| Model | PLD-601PTT |
| Instrument Type | Optical Light-Blockage Particle Counter |
| Detection Principle | Dual-Laser Narrow-Beam Light Obscuration (LO) |
| Sensor Generation | 8th-Generation Dual-Laser Sensor |
| Flow Control | Precision Metering Plunger Pump + Ultra-Precise Electromagnetic Flow Regulation |
| Software | V8.9 Integrated Analysis Suite (PC & Embedded Touch UI) |
| Compliance Standards | USP <788>, USP <789>, USP <797>, EP 10.0, BP 2019, JP 17, ChP 2015 & 2020 (Appendix 0903), GB/T 11446.9–2013, YBB00272004–2015, ISO 21501-4, ISO 11171, ISO 4406, NAS 1638, FDA 21 CFR Part 11 (Audit Trail, Electronic Signature, Role-Based 5-Tier Permissions), GLP/GMP Data Integrity Features |
| Calibration Traceability | JJG 1061–2010, ISO 21501-4, NIST-Traceable Latex Standards |
| Particle Size Range | 1–450 µm (customizable to 0.03–3000 µm per configuration) |
| Channel Resolution | 1000 adjustable channels (user-definable binning: 4/8/16/32/64/128/256/512/1000) |
| Sampling Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Sample Temperature Range | 0–80 °C |
| Ambient Operating Temperature | 0–50 °C |
| Accuracy | ±5% typical (per ChP 2020) |
| Counting Repeatability | ≤5% CV at 1000 particles/mL (coincidence error threshold) |
| Resolution | >95% (ChP-calibrated) |
| Display Interface | 10.1″ Capacitive Touchscreen + Optional Wireless Keyboard/Mouse |
| Data Management | Encrypted local storage, USB export, network backup, auto-recovery after power loss, full audit trail with timestamped operator actions |
| Brand | PULUODY |
|---|---|
| Model | PLD-601Q |
| Instrument Type | Optical Particle Counter |
| Detection Principle | Light Obscuration (LO) / Dual-Laser Narrow-Beam Sensor |
| Measurement Range | 1–450 µm (optional extension to 0.03–3000 µm) |
| Channel Resolution | 1000 adjustable channels (down to 0.01 µm bin width) |
| Sampling Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Accuracy | ±5% typical (per USP <788>, ISO 21501-4, ChP 2020) |
| Coincidence Limit | ≤5% at 1000 particles/mL |
| Temperature Range (Fluid) | 0–80 °C |
| Compliance | FDA 21 CFR Part 11, GMP/GLP audit trail, USP <788>/<789>, EP 10.0, ChP 0903, GB/T 11446.9–2013, GB 8368, ISO 21501-4, ISO 11171, NAS 1638 |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PLD-601S |
| Instrument Type | Optical Particle Counter (Light Obscuration Principle) |
| Detection Range | 1–450 µm (optional extension to 0.03–3000 µm) |
| Channel Resolution | 1000 adjustable channels (down to 0.01 µm bin width) |
| Flow Control | Precision metering piston pump + ultra-precise electromagnetic flow regulation |
| Calibration Standards | ISO 21501-4, USP <788>, EP 2.9.19, ChP 2020 Edition 0903, GB/T 11446.9–2013, JJG 1061 |
| Software Compliance | FDA 21 CFR Part 11 (audit trail, electronic signature, role-based 5-level access, data backup/recovery, power-fail protection) |
| Sample Compatibility | Aqueous & non-aqueous sterile solutions, lyophilized powders (after reconstitution), ophthalmic preparations, vaccines, WFI, medical packaging components, infusion devices, terminal filters |
| Operating Temperature | 0–80 °C (fluid), –15–50 °C (ambient) |
| Sampling Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Counting Accuracy | ±5% typical (per ChP/USP verification protocols) |
| Coincidence Limit | ≤2.5% at 1000 particles/mL |
| Resolution | >95% (ChP-aligned calibration), <10% (ISO 21501-4 aligned) |
| Regulatory Documentation Support | GLP/GMP-compliant test reports, validation templates (IQ/OQ/PQ), metrological traceability via NWMS (National Northwest Metrology Testing Center) and DFKW No. 116 Calibration Station |
| Brand | PULUODY |
|---|---|
| Model | PLD-601W |
| Origin | Shaanxi, China |
| Detection Principle | Light Obscuration (LO) / Dual-Laser Narrow-Beam Particle Sensing |
| Sensor Generation | 8th-Generation Dual-Laser Narrow-Beam Detector |
| Flow Control | Precision Metering Plunger Pump + Ultra-Precise Electromagnetic Flow Control System |
| Measurement Range | 1–450 µm (customizable sub-ranges: 1–100 µm or 4–70 µm(c) |
| Channel Count | 1000 adjustable channels |
| Sampling Flow Rate | 5–150 mL/min |
| Cleaning Flow Rate | 5–500 mL/min |
| Sample Temperature Range | 0–80 °C |
| Ambient Operating Temperature | 0–50 °C |
| Accuracy | ±5% typical (per ChP 2020 & USP <788>) |
| Coincidence Limit | ≤5% at 1000 particles/mL |
| Resolution | >95% (ChP-calibrated), <10% (USP/ISO 21501-calibrated) |
| Sampling Precision | <±1% |
| Compliance Standards | ChP 0903 (2015/2020), USP <788>, <789>, <797>, EP 10.0, BP 2019, YBB00272004-2015, ISO 21501-4, ISO 4406, NAS 1638, GB/T 11446.9-2013, JJG 1061 |
| Software | V8.9 Integrated Analysis Suite (PC & embedded touchscreen) with 5-level user权限 management, audit trail, electronic signature, and 21 CFR Part 11 compliance |
| Data Integrity | Auto-backup, restore, power-fail recovery, GLP/GMP-ready reporting |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PLD-601W |
| Instrument Type | Optical Particle Counter (Light Obscuration Principle) |
| Detection Range | 1–450 µm (customizable down to 0.1 µm with certified calibration) |
| Channel Resolution | 1000 adjustable size channels |
| Flow Control | Precision metering piston pump + ultra-precise electromagnetic flow regulation |
| Compliance | USP <788>, <789>, <797> |
| Software | V8.9 Integrated Analysis Suite (PC & embedded touchscreen) |
| Sample Temperature Range | 0–80 °C |
| Ambient Operating Range | 0–50 °C |
| Sampling Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Accuracy | ±5% typical (per ChP) |
| Overlap Error | ≤5% |
| Resolution | >95% (ChP-calibrated), <10% (USP/ISO-calibrated) |
| Calibration Standards | NIST-traceable latex spheres, JJG 1061–2010, or ISO 21501-4 reference materials |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | PLD-601X |
| Price | USD 26,500 (FOB) |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PLD-601X |
| Instrument Type | Optical Particle Counter |
| Detection Principle | Light Obscuration (LO) / Dual-Laser Narrow-Beam Sensor |
| Channel Resolution | 1000 channels |
| Measurable Size Range | 1–450 µm (optional extension to 0.03–3000 µm) |
| Sampling Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Temperature Range (Fluid) | 0–80 °C |
| Accuracy | ±5% typical |
| Counting Precision (Coincidence Limit) | ≤5% at 1000 particles/mL |
| Resolution | >95% (calibrated per ChP 2015/2020), <10% (per USP <788> & ISO 21501) |
| Software Compliance | FDA 21 CFR Part 11, Audit Trail, Electronic Signature, 5-Level User Permission Management |
| Calibration Standards | JJG 1061, ISO 21501, NIST-traceable latex spheres |
| Regulatory Alignment | USP <788>, <789>, <797> |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PLD-601XJ |
| 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 + Electromagnetic Flow Regulation |
| Measurement Range | 1–450 µm (customizable sub-ranges: 1–100 µm or 4–70 µm(c) |
| Resolution | >95% (per ChP 2015/2020), <10% (per USP/ISO 21501) |
| Channel Count | 1000 user-definable size channels (e.g., 4/8/16/32/64/128/128+ bins) |
| Sampling Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Sample Temperature Range | 0–80 °C |
| Ambient Operating Temperature | −15–50 °C |
| Accuracy | ±2.5% typical |
| Volume Accuracy | ±1% |
| Coincidence Limit | ≤2.5% error at 1000 particles/mL |
| Compliance | FDA 21 CFR Part 11, ASTM D6786, ISO 21501-4, ISO 11171, USP <788>, <789>, <797>, EP 10.0, ChP 0903, GB/T 11446.9-2013, YBB00272004-2015, GB 8368, ISO 4406, NAS 1638, MIL-STD-1246C, JIS B 9933 |
| Software | V8.9 Analytical Suite (PC + embedded touchscreen), 5-level role-based access control, full audit trail, electronic signature, data backup/recovery, power-fail protection |
| Calibration Standards | NIST-traceable latex spheres, ISO 21501-4 reference materials, JJG 1061 certified |
| Metrology Support | National Northwest Metrology & Testing Center (CNAS-accredited), Defense Science & Technology Commission Level-1 Particle Metrology Station No. 116 |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PLD-601XY |
| Instrument Type | Optical Particle Counter (Light Obscuration Principle) |
| Detection Range | 1–450 µm (optional extended range: 0.03–3000 µm) |
| Channel Count | 1000 customizable size channels (down to 0.01 µm resolution) |
| Flow Control | Dual-precision metering piston pump + ultra-precise electromagnetic flow control system |
| Compliance | USP <788>, <789>, <797> |
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China |
| Model | PLD-601Y |
| Instrument Type | Optical Particle Counter (Light Obscuration Principle) |
| Detection Principle | Dual-Laser Narrow-Beam Light Obscuration |
| Sensor Generation | 8th-Generation Dual-Laser Sensor |
| Flow Control | Precision Metering Plunger Pump + Ultra-Precise Electromagnetic Flow Control System |
| Sample Introduction | Disposable Needle Sampling Probe |
| Channel Resolution | 1000 Adjustable Channels (Down to 0.01 µm) |
| Detection Range | 1–450 µm (Extended Options: 0.03–3000 µm) |
| Accuracy | ±3% (Typical), Calibration Traceable to JJG1061, ISO 21501, or NIST-Traceable Latex Standards |
| Counting Repeatability | ≤3% Coincidence Error at 1000 particles/mL |
| Resolution | >95% (Ph. Ch. 2015/2020 compliant), <10% (USP/ISO 21501 compliant) |
| Flow Rate | Sample: 5–150 mL/min |
| Rinse | 5–500 mL/min |
| Fluid Temperature Range | 0–80 °C |
| Operating Ambient | −15–50 °C |
| Software | V8.9 Integrated PC & Touchscreen Analysis Suite |
| Compliance | FDA 21 CFR Part 11 (Audit Trail, Electronic Signature, Role-Based 5-Tier Permissions), GLP/GMP-Ready Data Integrity Architecture |
| Standards Supported | USP <788>, <789>, <797> |