The ETC is seeking information from companies intera
Organic electrochemistry has the potential to have significant technical and economic benefits for the synthesis of APIs. Electrochemical synthesis uses electrons as a reagent, which can enable more efficient transformations than the use of traditional chemical reagents, and can result in safer, more cost effective processes that have less waste generation, use fewer chemical raw materials, and result in a more streamlined chemical synthesis.
Electrochemistry is used widely in the chemical industry. However, existing manufacturing equipment generally is not suitable for the types of reactions of interest for the pharmaceutical industry. This lack of equipment availability is a major hurdle incorporating the technology into pharmaceutical processes. For electrochemistry to gain wide applicability in the pharmaceutical industry, it requires equipment infrastructure that is safe and robust to a range of reaction types and conditions, at a scale relevant to API manufacturing. For this reason, the ETC is interested in partnering to design and build lab and manufacturing scale electrochemical reactors that meet the safety, robustness and productivity needs of the pharmaceutical industry.
Download the Request for Information and submit your response.
RFP ISSUED JULY 16, 2020
QUESTIONS on RFP DUE AUGUST 10, 2020 – Latest Q&A (Updated Aug 11, 2020)
RFP RESPONSES DUE AUGUST 31, 2020
ested in supplying a commercially viable, automated instrument for the analysis of “visible particles” that are 100 µm and above in size. This instrument must allow non-invasive, non-destructive (no impact on the sample quality and property) measurement of particles and robust data analysis of particle size, number, and potentially shape/morphology.
Download the Request for Proposal and submit your response.
RFP ISSUED: June 6, 2023
QUESTIONS on RFP DUE to ETC: June 20, 2023
RFP RESPONSES DUE to ETC: July 14, 2023
Q&A – Note see FAQ document for answers to common questions
Section 2.2
Please clarify the request for an “automated instrument.” The document states that “fully automated systems detect particles by light reflection and transmission with subsequent image analysis to distinguish particles from container defects.” Beyond that, is there a requirement or desire for the system to automatically analyze multiple samples continuously without operator intervention (and if so, is there a target for the number of samples or throughput)?
Answer: The system should be capable of analyzing multiple product units of the same presentation (approx. 10 – 100) continuously without operator intervention; operator intervention including system reconfiguration is allowed when switching between sample types. Sample throughput (i.e., time required per sample analysis) is not a major requirement (if this stays within reasonable time limits e.g., a few min per sample).
Section 2.3.1
Please clarify the requirement for the testing to be “non-destructive.” For example, does this mean that sealed containers must remain intact, that the sample should not be removed, and that nothing should be put inside the container (such as by piercing the septum)?
Section 2.2 states that the system must “allow non-invasive, non-destructive … measurement” but “non-invasive” is not mentioned in Section 2.3.1 as a requirement. Please clarify.
Section 5.2 does not seem to mention “non-destructive” or “non-invasive.” Please clarify
Answer: The requirement is for the system to be non-destructive and non-invasive. The integrity of the container closure and the API should not be impacted by the automated inspection system.
Section 5.2
Regarding “Handling vials with volumes between 1-30mL” – will the consumable format be fixed within a run (i.e. using only a single vial size or PFS)? Is user intervention acceptable between runs to adapt the instrument to hold different vials/PFS?
Answer: The container closure format (e.g., vial, PFS, etc.) can be fixed within a run. User intervention is allowed for switching between different container closure systems (e.g., from vial to syringe, different size vials, to cartridges etc.).
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