75F40124Q00265-01_Q_A_FINAL.pdf

Question Response

1. Regarding IQ/OQ spec c.i, will manufacturers site acceptance testing (SAT) procedures and documentation, which are based on manufacturers factory acceptance testing, suffice for this requirement?

The manufacturer shall perform and provide IQ/OQ documentation that demonstrates the instrumentation meets the required technical requirements after installation is completed.

2. We are able to offer a co-localized SEM-Raman solution that can work with any SEM manufacturer and avoids the compromises in Raman performance that are inherent to physically combined SEM-Raman solutions. Typically we recommend that SEM and Raman are not physically combined in one system because it leads to a reduction in Raman imaging lateral/confocal spatial resolution, a loss in sensitivity for Raman signal, and a lack of flexibility due to the Raman component being locked into the SEM chamber. Instead, we can offer a separate Raman microscope with our co-localized microscopy platform—the NanoGPS (brochure attached). This allows for perfect co-localization of SEM and Raman information on their respective platforms without compromising Raman sensitivity or Raman spatial resolution. This also allows for full flexibility for the Raman, as both cryo-SEM-Raman work and ambient Raman work will be possible. If there are collaborations between the FDA and other locations, nanoGPS allows for shuttling of the sample from one laboratory to another, and return to the exact same analysis location on the sample. This solution is already compatible with all major SEM manufacturers.

Our solution is compatible with and superior to all the requirements listed in section (iii) of the required specifications. It will interfere with neither SEM performance nor Raman performance. It requires no modification to the SEM and can be fully retracted. It will provide Raman mapping and imaging with a spatial lateral resolution of <0.5 microns and confocal performance of less than 2 microns. 532 and 785 nm lasers with software controlled switching are available. Multiple Raman imaging modes are available, and the spectral range is from 50 cm-1 to 4000 cm-1 for both 532 and 785 nm. The spectral resolution will be better than 1.2-1.3 cm-1.

With this solution, would the FDA be interested in a sole submission for just the Raman portion, and allow for separate addition of the FDA’s preferred SEM manufacturer?

The offered solution would need to retain the ability to perform Raman analysis on cryogenic samples with suitable cryo-transfer methods if the samples are removed for Raman analysis from the cryogenic SEM chamber. Additionally, the requested solicitation is for a Cryogenic Scanning Electron Microscope Raman System and thus a sole submission for just Raman capabilities will be considered non-response.

3. Would a better lateral spatial resolution (down to <0.5 microns) and better confocal performance (<2 microns) be useful for the FDA’s work?

The listed specs meet or exceed the ones outlined in the solicitation and thus will meet the requested specified requirements

4. Would spectral resolution (down to 1.2-1.3 cm-1) be useful for the FDA’s work?

The listed specs meet or exceed the ones outlined in the solicitation and thus will meet the requested specified requirements

Cryogenic Scanning Electron Microscope Raman System (CDER-2024-121914)

RFQ 75F40124Q00265-01

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