May 5, 2022

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The ETC is seeking proposals from companies to develop of a commercially available scale-up reactor that meets the needs of the pharmaceutical industry. The project involves designing, building, and characterizing a commercially available pilot-plant scale photoreactor. Characterization is expected to include light characterization (photon count and spectral irradiation) and reactor characterization (material of construction, chemical compatibility, pressure rating, mixing, residence time distribution, heat transfer, scaling factor, etc.). The unit is expected to comply with the electrical hazard rating requirements of pharmaceutical manufacturing settings and be suitable for GMP qualification. 

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Download the Request for Proposals and submit your response.

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RFI ISSUED:  May 5, 2022

QUESTIONS on RFI DUE to ETC:  June 1, 2022

RFI RESPONSES DUE to ETC:  July 18, 2022

Q&A Received (last update July 8, 2022):  

1. We have been developing photoreactors and we could provide a proposal for your RfP. It is not clear what minimum volume is required for the reactor. Could you please give me more details? 5L 10L? 

   • We do not have a minimum volume requirement since it would depend on the reactor design and operation mode. We instead provided an expected productivity in the RfP as follows: Minimum 10 kg/day output (assuming pharmaceutically relevant photochemical reactions** with dilution of 10 L/kg, quantum yield of 0.5, and product molecular weight of 350 g/mol). 
     
     ** references to some pharmaceutically relevant photochemical reactions can be found in the RfP. ​

2. Page 6: “Characterization is expected to include light characterization (photon count and spectral irradiation)” does this refers to the light source, i.e., what is emitted by the LEDs, or to the reactor, what is effectively reaching the reaction mixture (actinometric characterization)? The characterization techniques required would be very different and it is important for us to understand how the different proposals will be compared and what should be included.

   • Characterization should include total number of photons or irradiance reaching the reaction mixture or at a minimum at the outer surface of the reactor that is exposed to light (if reaction material of construction transmittance data is provided as well). These could be performed either via actinometry or spectrometry. Additionally, the wavelength distribution (spectral irradiance) of the light source should be provided.​

3. Page 15: “Is compatible with safety requirements of manufacturing facilities. Electrical design should be compatible for safe handling of processes with flammable materials.” Are specific certifications or norms required, as these can vary from region to region? Is it specifically for the use in the US, Europe or another part of the world?​

   • Ability to certify for Class I Div I (Groups C and D) for the US clients and ATEX zone 1 IIB (minimum) or ATEX zone 1 IIC (optional) for the European clients. In addition, ability to have CE (Europe) and UKCA (UK) and EX marking showing compliance with the ATEX regulations for the European clients.​

4. Page 15: “Safety control in place for auto shutdown under excursions from operating conditions” does the operating conditions refer to the light source (the LED are exceeding a specific temperature) or to the chemical process (temperature/pressure/flow rate of the chemicals is outside of process parameters)?​

   • Light source: Shutting down of the LEDs if the LED temperature is exceeding a specific temperature or if the chiller fluid stops flowing to prevent damage to the light source. Additional controls could include shutting down of the LEDs if the light blocking cover is opened to prevent operational light exposure hazards.

   • Chemical process: Optional: Warning signals when process is outside the operating parameters

5. ​Page 15: “Safety control in place for auto shutdown under excursions from operating conditions” is it the electrical power of the LED that should shut down, or the full system, including the cooling of the LED?

   • Power to the LED should shut down while continuing to cool the LEDs ​
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