June 6, 2023 ​

 

​The ETC is seeking information from companies interested 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.

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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

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Q&A - Note see FAQ document for answers to common questions​​​

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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).

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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.

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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.).