Incoming Materials in Pharmaceutical€¦ · –The technology is proved to be highly effective for...

“See Through Raman identification of

Incoming Materials in Pharmaceutical

Warehouses”

10/2017 1

Dr. Enrique Lozano

Business Development Manager

International Sales Director

Handheld Solutions Potential• Handheld is the preferred option for warehouses and field analysis.

• Robustness, accessibility and performance are key parameters in their design….without forgetting: weight, shape, battery lifetime, etc.

• Mobility and sample accessibility is preferred to static options. Raman is one of the faster (and broader) implemented handheld techniques

• Raman introduces capability to read samples through most packages.

• Raman has proved to be a perfectly suitable tool for pharmaceutical warehouses.


• Existing operational protocols. Making “changes” too complex

and costly to introduce the new technologies

• Expertise. Projects are often delay or incomplete due to lack of internal

expertise

• Overestimate capability. Customer ideas doesn’t match physics!

• Ownership. Often introduction of such technologies involves transfer of

responsibilities

• Others


Handheld Solutions Restrictions

If standard Raman works, why develop the ST technology?

• Some customers need more:

– Sampling restrictions, e.g. access to sampling chamber

– Sample stability, thermal stability…

– Operation protocols

– Others, e.g. they want to use the unit for more…


Ideal scenario with Raman and LIBS for material identification in warehouses


85%

4%

7%4%

Raman 785

Raman 1064

LIBS

other

API

Excipients, solvents,

inorganics…

High fluorescents

samples…

NaCl, KCl,

counter ions,

Metals…

Diluted samples,

herbal extracts,

black, amorphous…

Reality check for material identification in the warehouse


80%

2%

7%11%

REAL Material ID

Raman785

Raman1064

LIBS

other

Real operation conditions

impossibilities to do more

Raman 785 Raman 1064

LIBS other

Theoretical material ID

Portable Raman, i-Raman PRO ST

• Some materials require higher performance for its identification

• Real operation conditions require it


11%

REAL Material IDRaman 785

Raman1064

LIBS

other

Does label

match content?

Chemical

without label

Sucrose in paper bag

See Through Raman Technology


• Illuminates and collects Raman scattered light coaxially from a larger sample area with decreased power density

• Specially designed with improved excitation and collection efficiency over larger sampling area

• High throughput spectrometer

• Advanced algorithms that isolate the Raman signal of the sample from the container

• identification against a spectral library

i-Raman® Pro ST StrengthsThe portable i-Raman Pro ST delivers rapid material screening and identification with immediate onscreen results, providing:


1. The ability to make Raman measurements through opaque, diffusely scattering surfaces

2. Larger sampling area for more representative measurements and repeatable results for heterogeneous materials such as powder blends, tablets, and natural products.

3. The lower power density allows the measurement of dark samples and samples that could suffer damage with conventional Raman, such as photo-labile and thermo-labile materials, and tissues.

4. Versatility with sample accessories for configurations for a range of applications including microscopy and stand-off Raman

Identify Samples Without Opening Them.• Chemical and pharmaceutical resellers can measure

and identify material samples in tamper-resistant sample bottles (glass or plastic) and avoid sample contamination

• Identify unknown liquids in colored plastic bottles –identify hazards and risks with minimum exposure

• Logistics companies: rapidly scan many samples without opening plastic bottles, envelopes

• Avoiding solvent exposure e.g. ATEX environments


Seeing More with the i-Raman Pro ST• Expanding Raman Technology to measure through barrier

layers: nondestructive, non-invasive testing• Expanding Raw Material testing to measure with even less

need for sampling – now ID can be done through opaque packaging

• Measure through white and other light colored plastics; fiber sample sacks, envelopes, thick amber glass bottles


• A high-throughput spectrometer, with larger penetration depth and larger sampling area, coupled with advanced identification algorithms for through container material ID

What the ST can Read Through


Thru Most of the polymers used as primary and secondary liners

We can read thru Glass (within logic!!!)

Some paper/cellulose liners

What we cannot…in fact, nobody can


Why? Raman signature of the

content will be far too diffused or

blocked.

We will not see if we are analysing

the sample or “air”

Some resins and pigments absorb

the radiation… no light – no

Raman

Raw Material ID Through Fiber Bags

• Larger sampling depths make it

possible to make measurements

through multi-layer fiber bags with the i-

Raman Pro ST


Identify Samples through White Plastic Bottle

• Bulk chemicals, as well as medicines, are commonly packaged in titanium dioxide filled polyethylene bottles, a diffusely scattering plastic


• The See Through i-Raman Pro ST, with its large effective sampling depth, allows materials inside the bottle to be identified

Larger Area - More Reproducible Results• Excedrin Migraine tablet has 3 active

ingredients – aspirin, acetaminophen, and caffeine

• The i-Raman Pro ST measures a larger area, and therefore provides more consistent ID results

• With conventional configuration of ~ 100 micron spot see large variability, and with this, and varying ID results including many false negatives


(a) overlay of 15 spectra acquired with conventional Raman configuration; (b) histogram of 43 HQI values with conventional Raman configuration. (c) overlay of 15 spectra acquired with ST Raman configuration; (d) histogram

of 17 HQI values with ST Raman configuration.

Can be used for something else?

• Yes

– The technology is proved to be highly effective for final QC control

– Bio-applications

– And “traditionally difficult” samples


Measure through coating on tablets• Tablets are often coated with

sucrose, TiO2 and colorants

• The i-Raman Pro ST technology, with its deeper penetration depth, and larger sampling size can measure the content through the coating


• With standard Raman confocal configuration, the coating is measured with little or no penetration to the medicine underneath

Identification of final products in final container


Used in e.g. clinical trials

See Through Raman Uses DecreasedPower Density

• The ST technology spreads the laser power over a large sampling area, thus minimizing sample damage so can measure dark samples.

• The decreased power density with the See Through probe expands the capability of Raman to identify sensitive samples such as gun powder – not recommended with conventional Raman, and even here tested in small quantity.


i-Raman Pro ST spectrum of gun powder: main peaks of sulfur and nitrate are evident.

Measurement through manila envelopes

• The See Through technology can effectively measure through paper envelopes –white, manila and other light colors


• As an example D-(+) glucose is readily identified when measuring through a manila envelope

• With a regular confocal Raman configuration, only the signature of cellulose is observable on top of a fluorescence background

D-(+) glucose through manila envelope

D-(+) glucose in manila envelope with standard config.

D-(+) glucose measured directly

Identify Materials Inside White Plastic Bottles

• Bulk chemicals, as well as medicines, are commonly packaged in titanium dioxide filled polyethylene bottles, a diffusely scattering plastic.


• The See Through i-Raman Pro ST and specialized algorithms account for container signature, so that materials inside the bottle can be identified.

Raman Spectra through White Plastic Bottles• Using the ST probe, with greater

penetration depth, a spectrum of material inside package is measurable.

• The contribution from the package is part of Raman spectrum.

• With STID algorithm get positive ID of material inside the plastic bottle.


STID: Match dextrose HQI =99.5

Standard and See Through Measurement: in Tyvek Envelope


Match HDPE, HQI=98.94

Match Sodium bicarbonate, HQI=99.70

Sodium bicarbonate measured directly

Larger Sampling Area - Better Sampling• The larger sampling area of the i-Raman Pro ST Raman makes the

measurement less sensitive to sample heterogeneity that is common in solid mixtures and natural products

• The spot size of several mm provides more consistent measurements over the sample area leading to more repeatable analysis results.

• A tablet with several active ingredients can give point to point differences when using the standard probe spot size of ~ 100 microns, reflecting the inhomogeneity of the sample composition.


The i-Raman Pro ST – Versatile Sampling• The i-Raman Pro ST system can be used with the Surface

Focus Adaptor, which optimizes measurements for a conventional Raman configuration of ~100 µm spot several mm from the probe tip – direct measurement of solid or sample in clear plastic bag

• Focus adaptor is best for liquids in glass bottle, solids in thick (double layer) glass container

• The high throughput i-Raman Pro ST has the adaptability to be used for conventional Raman measurements with other accessories such as video microscope, zoom lenses, industrial probes


Surface Focus Adaptor

Focus Adaptor

Dr Enrique Lozano

[email protected]

+447730871095

www.bwtek.com


mailto:[email protected]

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