The
MSLE100SWISS Liquid Particle Counter is designed for precise detection of
insoluble particles in various liquid samples, particularly in the
pharmaceutical and medical fields. Here are its key features, applications, and
technical parameters:
Features:
- Built-in USP
Testing Standards: Ensures compliance with
industry-standard particulate matter tests.
- Precision
Syringe Sampling: Provides accurate sampling
volumes with stable speed.
- Built-in
Calibration Curve: Meets ISO-21501 calibration
requirements.
- Automatic
Detection and Calibration: Includes
intelligent functions for performance judgment and calibration.
- Magnetic
Stirring: Adjustable stirring speed for
efficient sample mixing.
- USB Interface:
Allows direct data export with paperless electronic print report
capability.
- Software Support:
Easy integration with laboratory information management systems, supported
by LE-Assistant software for PC control and professional data processing.
- FDA 21 CFR Part
11 Compliance: Meets "Electronic Records
and Signatures" standards, ensuring secure user management.
Application:
- Injection
Testing: Compliant with CP, USP, EP, JP,
and other standards.
- Medical
Equipment Cleanliness Detection: Detects
contamination in medical devices and components.
- Filtration
Efficiency Testing: For verifying filtration
performance.
- Laboratory Water
Testing: Ensures particle detection in
laboratory water samples.
The
MSLE100SWISS is mainly used to detect insoluble particles in injections,
infusions, and sterile powders as per USP <788> “Particulate Matter in
Injections.” It also assesses particle contamination in medical packaging,
infusion equipment, anesthesia equipment, and oil-based liquid samples. The
instrument complies with USP <788>, <789>, and other standards,
offering intelligent, user-friendly features and robust operability.
Technical Parameters:
- Particle Size
Range: 2-100 μm
- Particle Size
Channels: 24
- Maximum
Detection Concentration: 10,000
particles/ml
- Accuracy:
± 10%
- Repeatability:
RSD <2% (for particles >1000/ml in 5ml sample)
- Resolution:
<10% (as per U.S.P, ISO 21501)
- Syringe
Specifications: 1ml, 5ml, 10ml*, 25ml
- Sampling Speed:
20 ml/min*
- Sample Volume
Accuracy: ± 1%
- Minimum Sampling
Volume: 0.2ml** (with 1ml syringe),
0.4ml (with standard configuration)
- Sensor Material:
316 stainless steel, quartz glass, PTFE, NBR
- Power Supply:
AC 100~240V, 50/60Hz
- Mixing Method:
Magnetic stirrer with adjustable speed
- Data Output:
RS232 port, USB, built-in thermal printer
- Display:
7-inch LCD color touch screen
- Size:
320(L)× 309(W)× 394(H) mm
- Weight:
11 kg
- Operating
Environment: Temperature 10-40°C; RH 0-95%
non-condensing
- Software System:
LE-Assistant for professional data handling
Standard configuration
Under 1ml syringe specifications the minimum sampling
volume is 0.2ml, under the standard configuration, the minimum sampling volume
is 0.4ml
The
MSLE100SWISS ensures compliance, accuracy, and ease of use in laboratory
settings.