RFI No. 42426-RD CLARIFICATIONS 2 PNNL RESPONSE).xlsx
XLSX spreadsheet 14 KB Posted
- Solicitation number
- 42426-RD
- Issued by
-
Department of Energy
About this file
This file is a Request for Information (RFI) clarifications document containing PNNL's responses to 15 vendor questions regarding mid-energy electron beam (eBeam) systems for medical device sterilization. The RFI seeks to define specifications for an anticipated RFP soliciting proposals for a self-shielded eBeam system deployable at end-of-line (EOL) facilities with optional inline capability.
Key clarifications provided include: (1) the 2.0 MeV energy specification refers to most-probable energy rather than average energy; (2) end-of-line systems are positioned away from production lines to accommodate multiple products and achieve higher throughputs, while inline systems integrate directly into continuous workflows; (3) end-of-line is emphasized as the primary objective due to broader factory integration potential, with inline considered an ultimate target requiring greater customization; (4) initial units will be purchased by government and integrated by medical device manufacturers at their own expense, with future commercial sales expected; (5) pricing information is not requested in the RFI response; (6) the eBeam vendor will provide recommended tray designs subject to customer approval prior to release for construction drawings; (7) cleanroom and GMP requirements, product range accommodations, product securement considerations, and conveyor specifications remain to be detailed in the RFP; (8) the RFP will specify applicable ISO/ASTM standards for radiation processing and dosimetry; (9) the medical device manufacturer hosting the equipment assumes regulatory responsibility with necessary vendor support for Installation Qualification (IQ), Operational Qualification (OQ), and Process Qualification (PQ); and (10) maximum product envelope dimensions and mass will be provided in the RFP rather than the initially specified 1-meter scan width to minimize labyrinth size and complexity.
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| File | Type | Posted |
|---|---|---|
| RFI No. 42426-RD [CLARIFICATIONS PNNL RESPONSE].xlsx | XLSX spreadsheet | |
| RFI No. 42426-RD - [Mid-Energy Electron Beam (eBeam) Systems].pdf |
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RFI – No. 42426-RD Questions
| ID# | Question | PNNL Response |
| 1 | Please state whether the 2.0 MeV energy refers to the most-probable energy or the average energy, as defined in the section 3.1.10 of ASTM/ISO 51649. | In the RFI, 2.0 MeV refers to the most-probable energy (i.e., the peak of the energy distribution) rather than the average energy (i.e., the mathematical mean of all energies). For LINACS, this average energy would be consistently lower than the most-probable energy since LINAC beam energy spectra are asymmetric, with greater numbers of electrons carrying lower energy than carry the most probable energy. However, for systems which create a beam of high energy electrons by accelerating them through one or more high voltage potential drops to reach a target energy, the result is a monoenergetic beam arriving on the vacuum side of the foil. In such a system, the energy of each electron is both the most-probable energy and the average energy, since there is no distribution of energies (until the electrons begin to transit the window foil). |
| 2 | The terms end-of-line and in-line are used to differentiate the scope of work. However, these terms are not defined here or in any standard. For the purpose of the RFI, can PNNL provide differentiating definitions? | An inline eBeam system is integrated directly into the continuous, moving workflow of a production line, meaning parts move automatically from previous process steps into and through the self-shielded eBeam machine. An end-of-line eBbeam system (essentially, it is an off-line system) is placed away from any single product's manufacturing process line, requiring transfer from manufacturing process line(s) to the end-of-line eBeam machine for processing. The end-of-line machine therefore allows one or more different products to be transferred to it and processed through it, whether those products are partially or fully assembled, whether they are in primary or secondary packaging. |
| 3 | It appears that end of line is the primary objective of this RFI. Is that correct? Is that because the sponsor has assessed that the primary market is end of line, or because there is a specific need for an end of line system for a certain application? | End-of-line is emphasized with the assumption that it will be more easily integrated into a greater number of factories to process a larger variety of products through the self-shielded eBeam system than would be possible if the product-handling of the eBeam machine was customized to fit into any specific in-line manufacturing process. The end-of-line system may also achieve higher throughputs than an in-line machine, when compared to those in-line production processes which cannot utilize the eBeam system's full capacity. In-line is considered the ultimate target for production lines with throughputs which can justify acquisition of a dedicated self-shielded eBeam system, but they likely will require greater customization. |
| 4 | Please clarify the intended procurement model. Would units be purchased by the government? For use in government facilities? Or is this intended for commercial sales? | Initial unit(s) are envisioned to be purchased by government, to be integrated by medical device manufacturer(s) at their expense. The intention of the program is to catalyze increased commercial sales of future units apart from government involvement. |
| 5 | For inline configurations, details about the interface, handoff, and communication scheme will significantly affect the pricing. How should we reflect the price for the various options? | The purpose of the RFI is to help define specifications for the anticipated RFP. Insight into configuration, interface, and communication aspects that should be prioritized in the RFP specifications is welcome in response to the RFI. Pricing information is not requested in response to the RFI. |
| 6 | For inline and end of line configurations, the cleanroom and GMP requirements will significantly affect the pricing. How should we reflect the price for the various options? | The purpose of the RFI is to help define specifications for the anticipated RFP. Insight into configuration, cleanroom, and GMP requirement aspects that should be prioritized in the RFP specifications is welcome in response to the RFI. Pricing information is not requested in response to the RFI. |
| 7 | Is the tray to be designed by the provider of the sterilization system? Or by the customer? | Since the tray design and the conveyance system through the eBeam cannot be designed independently, it is expected the eBeam vendor will provide a recommended tray design. Prior to RFC (release for construction) drawings, the tray design and conveyance design solutions must be approved as adequate for the products to be processed. |
| 8 | Should the system be designed for one specific product, or be able to accommodate a range of products? If the system should be designed to handle multiple products, how frequently would different products go through? Would it be changed hourly, daily, weekly, monthly, etc.? | The intent of the program is to consider system(s) for highest impact in terms of adoption of the technology. Insights into these considerations in response to the RFI are welcome to inform preparation of specifications to be included in the anticipated RFP. |
| 9 | Should it be assumed that product is well secured and can be moved without risk of jostling or changing the arrangement? | Insight into the consideration of product securement in response to the RFI is welcome to inform preparation of specifications in the anticipated RFP. |
| 10 | Should we assume that the product will be able to go up and down inclined conveyors? If so, is there a maximum allowed slope? | Insight into consideration of conveyor incline in response to the RFI is welcome to inform preparation of specifications in the anticipated RFP. |
| 11 | What kind of traceability is desired? Should it be at the tray, lot, package, or some other level? Will identification be on the product when supplied to the irradiation system, or do we need to affix? | Insight into this consideration in response to the RFI is welcome to inform preparation of specifications in the anticipated RFP. |
| 12 | Which ISO/ASTM and medical-device sterilization standards should we assume must be supported? | It is beyond the scope of the RFI to comprehensively identify all of the relevent ISO/ASTM standards for radiation processing and dosimetry of medical device sterilization such as ISO 11137, ISO/ASTM 52628/E268, etc. For the eBeam system to meet the needs of medical device manufacturers in the USA, the RFP will define these. Therefore, recommendations in this regard, in response to the RFI, are welcome to inform preparation of specifications in the anticipated RFP. |
| 13 | Who will be responsible for PQ and regulatory engagement: the equipment vendor, PNNL, end user, or a third party? | The medical device manufacturer to host the equipment is responsible to the regulatory engagement regarding their manufacturing facility, sterilization process, and products. Support from the Ebeam vendor is necessary. Therefore, recommendations for the vendor's support requirements for all of Installation Qualification (IQ), Operational Qualification (OQ), Process Qualification (PQ), in response to the RFI, are welcome to inform preparation of specifications in the anticipated RFP. |
| 14 | Scan width is specified at 1m, but the only product described is 45cm by 45cm. The conveyance and scan horn have to be designed around the largest product to go through, and the maximum width will drive the size and weight of the shielding, through both the size of conveyance turns and the size of the accelerator head. What maximum product size should we design for, and can the scan horn be set to be appropriate for that width, rather than the specified 1m? | Details on this point are to be determined. A maximum envelope of the product's three dimensions and mass will be provided in the RFP, in order to minimize labyrinth size and complexity. Description of considerations regarding conveyance and scan horn dimension with regard to maximum product dimensions is welcome in response to the RFI to inform preparation of specifications in the anticipated RFP. |
| 15 | Section 3.2 provides a dose uniformity requirement of <= 1.5. Should we assume this is the requirement for any product being irradiated? For instance, in Section 3.5 the DUR is not specified, but if it is a requirement, it will affect the throughput. | Section 3.2 requests to describe penetration and the maximum product thicknesses for two stated densities, for a product with dose uniformity requirement of equal to or less than 1.5. This is to characterize penetration of the vendor's beam for one possible set of product requirements. |
Section 3.5 is for characterizing throughput. For the homogeneous-density products in section 3.5, each with its dimensions and density given, the minimum dose in the product is a requirement. The DUR is a result, not a pre-defined requirement.
| 16 | Our current limit for a self-shielding Electron Beam Processing System (“EPS”) is below 1MeV. Our 2MeV models have the option of a conventional full concrete enclosure or a hybrid enclosure, thus resulting in a stationary unit (see below). Are either of these options acceptable to PNNL? | Feedback on the flexibility of specifications in the antipicated RFP to enable the program goal of increased use of eBeam technology by the medical device industry are welcome in response to the RFI. |
| 17 | For your information, we can design and build a self-shielded vault for a larger unit, however, we found the cost-effective point between a metal vault and a concrete vault (the pictures below) to be units of 1MeV – 1.5MeV. The thickness and weight of the steel to construct such a unit and then break it down for shipment is a large portion of the cost calculation. Also to consider is the additional reinforcements to the floor structure that would be necessary to properly support such a structure. | In spite of some vaults being the more cost-effective shield alternative for some eBeam installations, the RFP is anticipated to the preference of metal shielding for the procurement due to the need for the targeted eBeam system(s) to be adaptable to a wide variety of facilities, in which case the smaller size of a metal shield may be an important requirement. Responses to the RFI that inform these considerations in drafting the RFP are welcome. |
| 18 | Is there a reason PNNL is targeting energies at or around 2 MeV? Standard self-shielded units currently deployed and operational at med device manufacturing facilities, although capable of operating at 2 MeV, typically operate at 7 MeV. | As stated in Section 1.2, the anticipated RFP is expected to focus on self-shielded unit(s) deployable at end-of-line with optional in-line capability. A 7 MeV solution, though far more adaptable to thicker product, packaging, and presentation options, would be a much different integration challenge for compact end-of-line and in-line opportunities. The versatility of placing 2 MeV eBeams in highly variable (sometimes very limited-footprint) production environments is critical to this program. The lower maximum energy, therefore, is targeted, while being aware of its product and throughput limitations. |
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