FDA 21 CFR-11 Laboratory Liquid Particle Counter Water Injections
Testing
BN-LE100 intelligent particle detector is mainly used for the
detection of insoluble particles such as injections, infusions,
sterile powders, etc. in the 2015 edition of the Chinese
Pharmacopoeia, as well as the detection of particle contamination
of medical devices such as infusion equipment, anesthesia
equipment, and pharmaceutical packaging materials. It can be used
for particle detection in organic, colored and transparent,
oil-based and other liquid samples.
The instrument meets the standards of the 2015 edition of "Chinese
Pharmacopoeia" and United States Pharmacopoeia USP788. Built-in a
variety of dedicated testing standards and user-defined standards
to meet the requirements of different industries for liquid
particle pollution testing. The instrument provides more
specialized and intelligent service functions, stronger
compatibility and better operability. The unique LE-Assistant
software complies with 21 CFR-11 "Electronic Records and
Signatures" rules in the FDA. Provide professional paperless print
report output, equipped with intelligent automatic calibration
function.
Applications:
Injections testing under CP, USP, EP, JP and other standards
Cleanliness detecting of medical equipment / parts
Filtration efficiency detection
Laboratory water testing
Features:
1, Built-in special testing standards for the 2015 edition of
"Chinese Pharmacopoeia", GB 8368-2005, anesthesia appliances, etc.
2, Precise syringe sampling device, accurate sampling volume and
stable speed
3, Built-in calibration curve, in line with ISO-21501 instrument
calibration requirements
4, Intelligent automatic detection and automatic calibration
functions, instrument performance judgment and calibration
5, Magnetic stirring method, adjustable stirring speed
6, USB interface directly export data, paperless electronic
printing report
7, Powerful application software development support. Conveniently
connect to external equipment such as laboratory information
management system
8, LE-Assistant software realizes PC control and provides
professional data processing
9, Comply with 21 CFR-11 "Electronic Records and Signatures" rules
and standards in FDA and user classification management
Specifications:
| detection range | 2-400 μm |
| detection channel | 2~100μm |
| max sample concentration | 10000 particles/ml |
| accuracy | ±10% |
| repeatability | RSD<2%(partice counting>1000P/ml,5mlsample) |
| resolution | >90%(2015Chinese pharmacopoeia),<10%(USP,ISO21501) |
| syringe | 1ml,5ml,10ml*,25ml |
| sample flow rate | 20ml/min* |
| sample volume precision | ±1% |
| min sample volume | 0.2ml** |
| stirring method | magnetic stirring |
| power | AC 100~240V,50/60HZ |
| sensor material | 316 stainless steel,quartz glass,PTFE,NBR |
| data output | RS232;USB;thermal printer |
| Display | 7-inch LCD |
| dimension | 320(L)×309(W)×394(H) mm |
| weight | 11.0 kg |
| environment | T10-40 ℃;H0 ~ 95%,no condensation |
| software | LE-Assistant |
FAQ 1. Are you a factory or trading company?
We are a factory.
FAQ 2. Can you supply OEM?
OEM is available.
FAQ 3. What's the MOQ ?
(1). MOQ is 1 piece. The disposable supplies order usually at least
1 box.
FAQ 4. How about the order processing and lead time?
After order confirmation and receive the advance payment, we will
prepare the machines and goods. Usually could ready within 10
working day, when dispatch, will inform client and send the
documents for client making import customs clearance.
FAQ 5. What quality will be ensured?
100% new and quality inspection before delivery from factory.
Stable export box for good package.
FAQ 6. Can you guide the working?
The machine will deliver with English display, English manual and
video for installation and operation.
FAQ 7. How can your engineer replace parts if they are not beside
the machine?
Bonnin’s engineer could provide the solutions by email and video.
In warranty period, we can send spare parts for free and life-time
technical support for spare supply.
