Drug Photostability Tester
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| Brand | Bunkoukeiki |
|---|---|
| Origin | Japan |
| Model | NIJI-2 |
| Light Source | 150 W Xenon Arc Lamp |
| Spectral Range | 300–1150 nm |
| Bandwidth Options | 5, 10, or 20 nm (FWHM) |
| Irradiance | ≥1 mW/cm² (≥40 μmol·m⁻²·s⁻¹) |
| Illuminated Area Diameter | ≥Φ3 mm |
| Optical Delivery | SMA-coupled Φ3 mm Fiber, 1 m Length |
| Calibration Sensor | Integrated Silicon Photodiode Detector |
| Control Interface | Embedded LED Indicator + Manual Shutter |
| Dimensions (W×D×H) | 230 × 295 × 414 mm (excluding protrusions |
| Compliance | Designed for ICH Q1B, ISO 10993-12, and USP <1107> photostability protocols |
| Brand | RenKe |
|---|---|
| Origin | Shandong, China |
| Manufacturer Type | Manufacturer |
| Origin Category | Domestic |
| Model | RS-GZ-DC |
| Pricing | Upon Request |
| Accuracy | ±7% (at 25°C) |
| Illuminance Range | 0–65535 lux |
| Long-term Stability | ≤5%/year |
| Response Time | 1 s |
| Output Signal | Radio Frequency (RF) Wireless Transmission |
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | SHH-100GD |
| Pricing | Available Upon Request |
| Light Intensity | 4500 ± 500 lux (compliant with ChP 2020 <9001>) |
| Light Source | High-Efficiency LED Array |
| Noise Level | ≤35 dB(A) |
| Data Recording | Built-in thermal printer with adjustable print interval |
| Temperature Range | Ambient +5°C to 60°C |
| Humidity Range | 10–85% RH |
| Chamber Volume | 100 L |
| Dimensions (D×W×H) | 500 × 500 × 400 mm |
| Safety Features | Independent overtemperature protection, compressor overload protection |
| Environmental Operating Conditions | Ambient temperature 5–35°C, ambient humidity ≤85% RH |
| Validation Support | IQ/OQ documentation and execution services available |
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | SHH-100GD-2 |
| Pricing | Upon Request |
| Dimensions (D×W×H) | As specified per configuration |
| Operating Power | Measured at 25°C steady-state |
| Ambient Operating Conditions | 5–35°C, ≤85% RH |
| Compliance | ICH Q1B, USP <115>, Chinese Pharmacopoeia 2015 Ed. (Chemical Drug Stability Guidance), FDA Guidance for Industry — Photosensitivity Testing |
| Data Recording | Dual-channel — thermal printer (adjustable interval) + PC-based RS485 logging |
| Safety Protections | Independent chamber overtemperature cutoff, refrigeration compressor overload protection |
| Validation Support | IQ/OQ protocol documentation and on-site execution available |
| Warranty | 12 months post-acceptance, lifetime technical support |
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | SHH-100GD-2F |
| Pricing | Upon Request |
| Dimensions (D×W×H) | Not specified in input |
| Illuminance Compliance | ≥1.2×10⁶ lux·hr (total visible), ≥200 W·hr/m² (near-UV) |
| Control Architecture | Centralized PC-based control supporting up to 30 units |
| Data Logging | Dual-mode — thermal printer (adjustable interval) + real-time digital recording via RS485 |
| Safety Protections | Independent chamber overtemperature cutoff, refrigeration compressor overload protection |
| Environmental Operating Range | 5–35°C ambient temperature, ≤85% RH |
| Warranty | 12 months from commissioning, lifetime technical support |
| Qualification Support | IQ/OQ documentation and execution services available |
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | SHH-200GD |
| Pricing | Upon Request |
| Light Intensity | 4500 ± 500 lux |
| Light Source | High-Efficiency LED Array |
| Noise Level | Ultra-Low (Quiet Operation) |
| Data Recording | Built-in Thermal Printer with Adjustable Print Interval |
| Temperature & Illuminance History Logging | Yes |
| Warranty | 12 months from commissioning, lifetime repair support |
| Validation Support | IQ/OQ Documentation and Execution Services Available |
| Safety Protections | Independent Chamber Over-Temperature Protection, Compressor Overload Protection |
| Operating Ambient Conditions | 5–35 °C, ≤85% RH |
| Chamber Dimensions (D×W×H) | Not Specified in Input |
| Power Consumption | Measured at ~40 °C / 75% RH with Single Refrigeration Unit Active |
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | SHH-200GD-2 |
| Pricing | Upon Request |
| Dimensions (D×W×H) | 600 × 750 × 1800 mm |
| Illumination Uniformity | ±10% across chamber volume |
| Light Source | UV-A + visible spectrum fluorescent lamps (320–400 nm & 400–800 nm) |
| Total Illuminance Requirement | ≥1.2 × 10⁶ lux·h (per ICH Q1B) |
| Near-UV Energy Dose | ≥200 W·h/m² (320–400 nm) |
| Photometric Control | Digital irradiance sensor with real-time feedback loop |
| Temperature Setpoint Range | 15–30°C (typical photostability test condition: 25°C ± 2°C) |
| Humidity Control | Non-controlled (open-air design per ICH Q1B) |
| Cooling System | Air-cooled hermetic compressor with over-load protection |
| Safety Protections | Independent chamber over-temperature cutoff, compressor thermal overload relay, door interlock switch |
| Data Logging | Dual-channel — RS485-modbus RTU to PC (continuous .csv export), built-in thermal printer (adjustable print interval: 1–60 min) |
| Remote Monitoring | TCP/IP Ethernet interface |
| Compliance | ICH Q1B, USP <115>, Chinese Pharmacopoeia 2015 Ed. General Chapter 9001, FDA Guidance for Industry: Photosensitivity Testing (2022), ISO/IEC 17025-aligned validation support (IQ/OQ documentation provided) |
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | SHH-200GD-2F |
| Pricing | Available Upon Request |
| Compliance | ICH Q1B, USP <115>, FDA Guidance for Industry (Photostability Testing), Chinese Pharmacopoeia 2015 Edition (General Chapter 9001) |
| Illuminance Control Range | 4500 ± 500 lx (for visible light exposure) |
| Chamber Dimensions (D×W×H) | 600 × 600 × 1300 mm |
| Internal Volume | 200 L (2-layer illuminated shelf configuration, with one photosensitive shelf per layer) |
| Operating Temperature | 25 °C ± 2 °C (ambient-controlled environment required: 5–35 °C, ≤85% RH) |
| Cooling System | Hermetic Compressor with Overload Protection |
| Data Logging | Dual-channel — RS485 digital output to PC + built-in thermal printer (adjustable print interval) |
| Remote Monitoring | TCP/IP-enabled Ethernet interface |
| Safety Features | Independent chamber overtemperature cutoff, compressor thermal overload protection |
| Validation Support | IQ/OQ documentation package and on-site execution services available |
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | SHH-300GD-2 |
| Pricing | Upon Request |
| Dimensions (D×W×H) | Not Specified in Input |
| Illuminance Compliance | ≥1.2×10⁶ lux·h (total visible), ≥200 W·h/m² (near-UV) |
| Temperature Control Stability | 25°C nominal operating point |
| Environmental Operating Range | 5–35°C ambient temperature, ≤85% RH |
| Safety Protections | Independent chamber overtemperature cutoff, refrigeration compressor overload protection |
| Data Recording | Dual-mode — thermal printer (adjustable print interval) + real-time PC logging via RS485 |
| Remote Capability | Multi-unit centralized control & remote commissioning via LAN/internet (up to 30 units per host) |
| Validation Support | IQ/OQ documentation and execution services provided |
| Warranty | 12 months from acceptance, lifetime repair support |
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | SHH-300GD-2F |
| Pricing | Upon Request |
| Dimensions (D×W×H) | Not Specified in Input |
| Operating Power | Measured at 25°C Constant |
| Ambient Operating Conditions | 5–35°C, ≤85% RH |
| Compliance | ICH Q1B, USP <1191>, Chinese Pharmacopoeia 2015 Edition, FDA Guidance on Photosensitivity Testing |
| Data Logging | Dual-mode (RS485 + built-in thermal printer) |
| Remote Monitoring | TCP/IP-enabled, up to 30 units per host PC |
| Safety Protections | Independent chamber overtemperature cutoff, compressor overload protection |
| Warranty | 12 months post-commissioning, lifetime technical support |
| Qualification Support | IQ/OQ documentation and execution services available |
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Product Origin | Domestic (China) |
| Model | SHH-400GD-2 |
| Pricing | Upon Request |
| Chamber Dimensions (D×W×H) | 600 × 600 × 1200 mm |
| Illumination Uniformity | ±5% across sample zone |
| Light Source | UV-A + Visible LED Array (320–800 nm) |
| Total Illuminance | ≥1.2 × 10⁶ lux·hr (ICH Q1B compliant) |
| Near-UV Energy Dose | ≥200 W·hr/m² (λ = 320–400 nm) |
| Reference Illuminance Level | 4500 ± 500 lux (ChP 2015 General Chapter 9001) |
| Operating Temperature Range | 25 ± 2°C (ambient-controlled) |
| Ambient Conditions | 5–35°C, ≤85% RH |
| Power Consumption | 1.8 kW (at 25°C steady state) |
| Safety Protections | Independent chamber overtemperature cutoff, compressor overload protection |
| Data Logging | Dual-channel — real-time RS485 digital export + thermal micro-printer (adjustable interval) |
| Remote Capability | TCP/IP-based Ethernet interface |
| Compliance | ICH Q1B, USP <1191>, ChP 2015 Vol. II 9001, FDA Guidance for Industry: Photosensitivity Testing (2022), ISO/IEC 17025-aligned validation support |
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | SHH-400GD-2F |
| Pricing | Available Upon Request |
| Dimensions (D×W×H) | 650 × 750 × 1850 mm |
| Illumination Uniformity | ±10% across test chamber floor |
| Light Source | UV-A + Visible LED Array (320–400 nm & 400–800 nm) |
| Total Illuminance Requirement | ≥1.2 × 10⁶ lux·hr (per ICH Q1B) |
| Near-UV Energy Dose | ≥200 W·hr/m² (320–400 nm) |
| Photometric Control Accuracy | ±500 lux (target 4500 lux per ChP 2015) |
| Operating Temperature Range | 25 ± 2 °C (ambient-controlled mode) |
| Ambient Conditions | 5–35 °C, ≤85% RH |
| Power Consumption | 2.8 kW (at 25 °C steady state) |
| Safety Protections | Independent overtemperature cutoff, compressor overload protection, door interlock |
| Data Logging | Dual-channel — real-time RS485 digital export + thermal printer (adjustable interval) |
| Remote Capability | TCP/IP-enabled |
| Compliance | ICH Q1B, USP <1191>, FDA Guidance on Photosensitivity Testing, ChP 2015 Vol. IV “Stability Testing of Chemical Drugs”, ISO/IEC 17025-aligned validation support |
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Product Origin | Domestic (China) |
| Model | SHH-GD Series |
| Pricing | Available Upon Request |
| Light Source | High-Efficiency LED Array |
| Illuminance | 4500 ± 500 lux (compliant with USP <9001> and ICH Q1B) |
| Temperature Range | Ambient +5°C to 60°C (typical operational range: 25–40°C) |
| Humidity Range | 10–85% RH (with refrigeration-assisted dehumidification) |
| Noise Level | ≤45 dB(A) |
| Data Recording | Built-in thermal printer with adjustable print interval (1 min–24 h) |
| Safety Protections | Independent chamber overtemperature cutoff, compressor overload protection |
| Environmental Operating Conditions | Ambient temperature 5–35°C, ambient humidity ≤85% RH |
| Power Consumption | ≤1.2 kW (measured at 40°C / 75% RH with single-stage refrigeration engaged) |
| Chamber Dimensions (W×D×H) | Varies by submodel (e.g., SHH-GD-150: 500×450×650 mm |
| SHH-GD-300 | 600×550×850 mm) |
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | SHH-GD-2 |
| Pricing | Upon Request |
| Illuminance Range | ≥4500 ± 500 lx (per Chinese Pharmacopoeia 2015) |
| Total Illuminance Dose | ≥1.2 × 10⁶ lx·h |
| Near-Ultraviolet Energy | ≥200 W·h/m² (per ICH Q1B) |
| Chamber Dimensions (D×W×H) | As specified per configuration (with optional light-sensitive shelf ×1) |
| Operating Power | Measured at stable 25°C setpoint |
| Ambient Operating Conditions | 5–35°C, ≤85% RH |
| Data Logging | Dual-mode — thermal printer (adjustable print interval) + real-time PC recording via RS485 |
| Remote Monitoring | TCP/IP-enabled, supports up to 30 units per host PC |
| Safety Protections | Independent chamber overtemperature cutoff, refrigeration compressor overload protection |
| Warranty | 12 months from commissioning |
| Qualification Support | IQ/OQ documentation and on-site execution available |
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | SHH-GD-2F |
| Pricing | Available Upon Request |
| Compliance | ICH Q1B, USP <1191>, Chinese Pharmacopoeia 2015 Edition (Chemical Drug Stability Guidance), FDA Guidance for Industry on Photosensitivity Testing |
| Illumination Requirements | Total illuminance ≥ 1.2 × 10⁶ lux·h |
| Visible Light Intensity | 4500 ± 500 lux |
| Control Architecture | Centralized digital control with remote monitoring capability |
| Data Logging | Dual-channel — thermal printer (adjustable print interval) + real-time PC-based recording via RS485 interface |
| Safety Protections | Independent chamber overtemperature cutoff, refrigeration compressor overload protection |
| Environmental Operating Range | Ambient temperature 5–35 °C |
| Dimensions (D×W×H) | As specified per configuration (standard unit includes one photosensitive shelf) |
| Power Consumption | Measured at steady-state 25 °C operation |
| Validation Support | IQ/OQ documentation and execution services available |