PHARMACEUTICAL PROCESSING | JANUARY/FEBRUARY 2015 33 n
and 21 CFR Part 11 compliant electronic signature capabilities. By introducing the new generation of handheld
Raman technology into the RMID workflow, companies
can work towards overcoming these challenges and
achieve leaner manufacturing processes, lower costs per
analysis and increased inspection rates without compromising quality.
Raman spectroscopy is a non-destructive, reliable, efficient and cost effective method for raw material identification. With a minimal need for sample preparation, the
availability of handheld instrumentation, and the ability to
measure samples through containers, the Raman technique
offers significant advantages for biopharmaceutical applications. The next generation in handheld Raman spectroscopy could enable the rapid characterization and quality
control of complex cell culture media.
In the past, users of handheld Raman devices with
785nm or 532nm visible range extraction lasers were
unable to identify colored substances, materials through
colored containers or samples with high fluorescence
The Progeny’s 1064nm excitation laser enables users to
broaden their analysis range thanks to minimal fluorescence. The combination of longer excitation wavelengths
with a portable handheld device is set to revolutionize raw
material identification by allowing analysis to take place
quickly and efficiently on site, while simultaneously generating more accurate, reliable results.
These advances in quality control allow those involved
in the manufacturing process to have increased control
over the quality of cell culture media.
Figure 1: Comparison of 785nm (red) and 1064nm (blue) excitation
Raman spectra of cell culture medium
changes in the sample being measured. However, 1064 provides much clearer results. When using 1064nm excitation
laser, most cell culture media materials do not fluoresce
and can therefore be quickly and reliably identified using
handheld Raman spectroscopy. This development in handheld Raman technology means that closely related materials can be distinguished with higher quality data.
Improving QC and Efficiency with Raman
With this drive towards 100 percent inspection and lean
manufacturing, handheld Raman optimizes the RMID process in a number of ways. Handheld Raman devices provide the ability to analyze, identify and qualify materials
against specific criteria on the spot.
This removes the delay in waiting for lab results, improving cycle time, optimizing material movement, and the
need for quarantine. Handheld Raman instruments can
also identify substances through bags and other types of
packaging, thus eliminating the risk of compromising the
integrity of the contained materials. All these factors result
in an improved workflow, reduction in space and inventory,
as well as time and cost savings.
Ease of use is a key consideration for the new generation
of handheld devices, and the Progeny has been engineered
to be quickly and easily implemented into customized
RMID workflows. Features include a touchscreen user interface inspired by modern smartphone, one-handed operation and an angled display. This means that the device can
quite literally ‘point and shoot’ at the container being analyzed while the user simultaneously checks the measurements on screen.
In order to ensure accurate data entry tracking and
compliance, Progeny has an integrated digital camera
Figure 2: Raman spectra collected with 1064nm laser excitation of two
slightly different cell culture media