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NanoLIBS® Handheld Laser Induced
Breakdown Spectroscopy (LIBS)
for Rapid Identification of Incoming
Raw Material Salts
+1-302-368-7824
www.bwtek.com
[email protected]
Moving Toward 100% Raw Material Identification
NanoLIBS®: Faster, Easier, Safer
To date, 48 countries and bodies have come together under the Pharmaceutical Inspection
Co-operation Scheme (PIC/S) to improve and harmonize pharmaceutical standards and
regulations, with more expected each year. National regulatory bodies have begun to
formulate policies around PIC/S that involve, among other things, 100% inspection and
verification of incoming raw materials. This has led many pharmaceutical companies to turn
to technologies such as handheld Raman & laser induced breakdown spectroscopy (LIBS) to
meet their analysis needs.
B&W Tek developed the NanoLIBS® handheld LIBS analyzer using the same concepts and
workflows that pharmaceutical manufacturers already appreciate from the NanoRam to
help companies comply with 21CFR Part 11, GMP, regional Pharmacopeias, and local policies
based on PIC/S recommendations. When a
batch of salts is received, a sample less than
a gram can be quickly taken in the receiving
area and pressed into a tablet form on the
spot. With the tableted salt, the NanoLIBS
takes only seconds to give an identification
result of the salt based on the elemental
composition to notify the user whether the
sampled drum is what it is supposed to be.
Identification of Incoming Raw Material Salts: Ensuring Quality
While the complementary NanoRam Raman spectrometer gives users the ability to identify and
verify most pharmaceutical raw materials, LIBS allows users to identify monoatomic salts such as
KCl, KI, NaBr, and NaCl, which are outside the capabilities of molecular spectroscopic techniques.
This requires manufacturers of infusions, injections, and liquid delivery drugs that may utilize
hundreds of drums of salt per week to seek other methods to verify their raw materials. Current
methods such as titration or laboratory atomic spectroscopy methods require lengthy preparation
and analysis times and require precision and care when handling various other chemicals in the
preparation process. Fortunately, breakthroughs in (LIBS) technology now make it possible to
significantly reduce process times and the load on pharmaceutical labs while eliminating waste
associated with sample preparation.
www.bwtek.com
The NanoLIBS allows companies to quickly implement a ready solution for raw material salt
identification that is easy to use and understand. Data from the device can be transferred
via Wi-Fi or Ethernet to a secure database to generate reports that provide traceability. The
NanoLIBS gives pharmaceutical companies the complementary technology that they need to
save time in analysis and significantly decrease down-time where raw materials are tied up in
quarantine as they are tested.
www.bwtek.com
NanoLIBS: The Complete Solution
The NanoLIBS is an all-in-one device that is operated via the
built-in touchscreen, barcode scanner, and tablet holder to
simplify workflows. The device comes with a tablet press
for easy creation of tablets for analysis, two batteries and a
charging cradle to decrease down times, and a full suite of
support and services to ensure that companies have all the
paperwork and support necessary to keep regulators and
customers satisfied.
Services & Support
• Comprehensive Product Warranty
• Extended Warranty Options
• DQ/IQ/OQ/PQ Documents & Implementation
• Method Validation
• Library and Method Development Services
• Annual Instrument Performance Certification
• Educational Services
• Applications Development
• Implementation & Service
• Customized On-site training
• SOP Templates & Development
Contact Us
www.bwtek.com
+1-302-368-7824
[email protected]
Doc-Rev: 400000189-A (8/29/2016)