June 6, 2023

UPDATED NOVEMBER 4,2024 ​

 

This RFP is being re-opened for responses. 

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​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

RFP 2024 EXTENSION 

• QUESTIONS on RFP Due to ETC: December 6, 2024

• RFP RESPONSES DUE to ETC: January 10, 2025

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

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• Question 1: The specifications in sections 2.3.1 and 2.3.2 request counting the number of particles and measuring their characteristics for particles over 100 μm and smaller than 50 μm, respectively.

  • 1-1. Is it correct to assume that measuring these values is not required for particles in the 50–100 μm
    range?

    • ANSWER: This is not correct. The specifications in section 2.3.1 is ≥ 100 µm. The specification in section 2.3.2 is ≥ 50 µm.

  • 1-2. What level of resolution is required to accurately determine particle size?

    • ANSWER: 1 µm resolution is acceptable.

  • 1-3. Are the required data quality for each parameter (i.e., size and potentially morphology, solution behavior, optical properties) identical for both ranges?

    • ANSWER: Yes. 

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• Question 2: What is the final required outcome for this analysis? Should the result be a report listing the required values, or a pass/fail determination? If it is the latter:

  • 2-1. What are the criteria for pass/fail?

    • ANSWER: The results should be a report listing the required values including particle count, and particle morphology/information for each individual particle, and particle images. The pass/fail criteria for each individual container will be user defined (e.g., fail on "x" particles counted). 

  • 2-2. Should failed samples be automatically eliminated?

    • ANSWER: Failed samples should be segregated from passed samples to allow for further testing.

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• Question 3: Is there flexibility to modify or select the sample container if it impacts the measurement process?

  • ANSWER: The instrument should be capable of handling different container types (e.g., vial vs pre-filled syringes) and sizes (e.g., 1-mL vs 2-mL pre-filled syringe). It is not possible to change the primary container type of a sample if it impacts the measurement.

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• Question 4: Could you provide detailed specifications for the sample container, including materials, hardware design and whether it is supplied with or without additional packaging and labeling?

  • ANSWER: The containers will be supplied nude/naked (i.e., without a label). The containers will include common containers used in the pharmaceutical industry (e.g., R2 vial, etc) but also container types/sizes specific to an industry member. Containers can be made out of glass or transparent plastic.  

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• Question 5: Is it permissible to meet the requirements of sections 2.3.1 and 2.3.2 using multiple instruments?

  • ANSWER: Yes, this might be permissible in certain situations. For example, you can have one instrument to count particles (requirement from section 2.3.1) and a different instrument to classify particles based on orthogonal technology other than particle imaging (requirement from section 2.3.2).

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• Question 6: Are there any limitations on the light source or detection technologies (e.g., UV, laser, fluorescence, Xray) to prevent potential negative impacts on the sample?

  • ANSWER: The measurement should be non-destructive and should not have a negative impact on the sample. Light sources, intensity, and duration that can potentially negatively impact the molecule should be avoided. 

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• Question 7: Are there any risks to the samples associated with the use of ultrasonication?

  • ANSWER: Potentially, ultrasonication is not recommended. 

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• Question 8: What specific temperature range should be maintained?

  • ANSWER: The temperature range should be similar to those encountered in a typical lab or manufacturing environment; 15C - 25C. 

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• Question 9: Should vibration and physical shock during the measurement process be managed to prevent any impact on the samples? If so, what is the acceptable level?

  • ANSWER: Samples can be rotated to make particles move in solution because they could have settled. Excessive force such as ultrasonication or vortexing should be avoided as it can cause protein precipitation.

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• Question 10: How many samples should be measured per hour and per day?

  • ANSWER: This is supposed to be a lab based system for development labs. There are no strict requirements on throughput but it should be on the order of 10s to a few hundred per day.

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• Question 11: Are all samples measured, or are a representative subset randomly selected for measurement?

  • ANSWER: All samples should be measured. 

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• Question 12: What is the purpose of using AI/ML in this process?

  • ANSWER: As described in section 2.3.2, the purpose of AI/ML is to aid in particle classification (i.e., image analysis). 

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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.)​​