FDA 21 CFR-11 Laboratory LPC Liquid Particle Counter system Water Injections Testing

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:

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.