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Request for Information (RFI) Eppendorf 120L Bioreactor/Fermenter for Good Manufacturing Practice (GMP) Usage General Information: This is an RFI as defined in FAR 15.201(e) to ascertain whether a com... Request for Information (RFI) Eppendorf 120L Bioreactor/Fermenter for Good Manufacturing Practice (GMP) Usage General Information: This is an RFI as defined in FAR 15.201(e) to ascertain whether a commercial item exists that provides the capabilities described herein. This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI will be treated as business confidential information. Nonetheless, submitters should properly mark their responses if the information is confidential. Responses to the RFI will not be returned. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expense associated with responding to this RFI. RFI Response and due date: 13 June 2024 10:00 AM EDT Instructions to Responders: Responses from all capable and qualified sources are encouraged to respond to this request. White papers should adhere to the following formatting and outline instructions: 1. All submissions shall be made electronically and be in one of the following formats: Microsoft Word or Adobe PDF. 2. Cover Page (1page) • Title • Organization • Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses) • Topic area(s) addressed • NAICS Code 3. Interested parties are asked to respond to this RFI and submit a capabilities statement that supports the focus of this RFI as detailed below. Please review the place of performance requirements. Please submit written responses via email in Microsoft Office 2000 or 2007 format. All responses should be complete: in 12-point font; and not to exceed 3 pages total, including graphics, tables, and appendices. No hardcopies shall be accepted. No written solicitation document is available at this time. Telephone requests will not be honored, and no bidders list shall be maintained. No inquiries regarding any potential future acquisition activities shall be entertained. Potential offerors are requested to direct all questions via email to the Point of Contact listed below. Responses are due to the Point of Contact, Ms. Rebecca Wisner at email: rebecca.c.wisner.civ@health.mil no later than 10:00AM EDT, 13 June 2024 Specifications: The requirement for 120 L Bioractor Fermentor for GMP Usage manufactured by Eppendorf includes the following specifications: The fermenter must function in a way as to not disrupt ISO 8 clean room criteria. The fermenter tank shall have a working volume that ranges from 45L to 120L, at a minimum. Metallic product-contact surfaces and distribution piping shall be 316L stainless steel. Non-metallic product-contact surfaces, such as gaskets or elastomers, shall be constructed of USP Class VI materials and be suitable for the processing conditions. Materials shall not shed particles, or any contaminates that could contaminate product or materials within the vessel. All product-contact connections shall be of a sanitary/hygienic type, tri-clamp or owner-approved alternate. The materials of construction shall be capable of withstanding steam sanitization, chemical cleaning and passivation. All construction materials that are normally exposed to the environment shall be compatible with 70%IPA and Sporklenz The fermenter shall be equipped with two sight glasses and a light. Sight glasses shall be mounted in the side and head of the vessel. All pressure rated equipment (fermenter, jacket, heat exchanger, etc.) and assemblies associated with the fermenter shall comply with the latest ASME codes and standards. Chamber and jacket shall be stamped with ASME Section VIII stamp. Electrical housings shall be produced according to NEMA 4X standards and certified by Underwriter Laboratories or analogous standard. Major equipment and control wiring shall be labeled and identified. Tag numbering shall be consistent between the devices and all corresponding documentation. Name plate shall be attached to the 100-Liter Fermenter Skid frame located in an accessible and visible location. The plate shall include, at a minimum: • Manufacturer’s name • Model number • Serial number • Year of manufacture • Operational and safety ranges • Utility services information Wetted surfaces shall have a surface finish of ?20 µ” RA ID and shall be free of pits, burs, scratches, or similar surface defects. The fermenter shall be provided with a sanitary rupture disk and a burst disk indicator. The discharge shall be piped to a safe location near the floor. The fermenter shall be equipped with an exhaust line condenser. System shall be equipped with redundant filter housings equipped with steam heaters with temperature control to prevent damage to the filter. Exhaust gases shall pass through a redundant, parallel 0.2um steam jacketed exhaust filters prior to leaving sterile equipment boundary. Access ports shall be provided near 0.2µ hydrophobic housings points to allow for filter integrity testing without disassembly of the equipment. The fermenter shall be equipped with three Rushton turbine impellers. The impeller positions shall be adjustable along the agitator shaft. The system shall be equipped with four (4) fixed-speed peristaltic pumps with adjustable addition rates via tubing diameter and capable of interfacing with, at a minumum, two (2) external peristatic pumps. System shall be capable of providing a start/stop signal as well as a setpoint (% Full Speed) to the external pumps. The fermenter shall be equipped with a sample valve assembly for in-process sample acquisitions. Sample valve shall be sterilizable by steam with no dead leg to be used for in-process and final fermentation aseptic sampling. The Fermenter shall be capable to be operated and fully maintained in space with 9’0” ceiling height. Fermenter and associated piping shall be adequately sloped and without dead legs to support complete system draining. The agitator seal shall be constructed of material suitable for use in a GMP Fermenter that will be cleaned with clean in place (CIP) / sterilize in place (SIP) processes. The fermenter lower side wall shall be equipped with a minimum of four 25 mm ports (ingold style). The fermenter upper side wall shall be equipped with at least four steam sterilizable addition ports. The head plate shall be equipped with ports for foam sensing, pressure sensing, CIP spray balls. • Gasses Gases shall be introduced into the fermenter via a sparger system. The thermal mass flow controller (TMFC) shall meter the gases sparging into the system per batch recipes. Inlet gases to the sparger shall be equipped with two steam sterilizable 0.2µ filters in series. System shall permit integrity testing in situ. Fermenter shall be equipped with gas overlay with flow control via TMFC. • Temperature control Fermenters shall be provided with temperature transmitter, heat transfer jackets, and a heat exchanger, to maintain temperature setpoints. • CIP Skid The fermenter shall be designed and/or capable of interfacing with an existing Sanimatic CIP system (Ultra Flow Series 45). CIP connection, configuration and process control shall minimize the manual interaction required by the operator. This shall include the use of recipes, automated control valves, and actuated isolation valves in the Fermenter design to control the various flow paths during CIP. The unit shall be fitted with all necessary piping, drain lines, valves, spray ball, etc. necessary for reliable CIP set up and operation by a single operator. The spray ball wands shall have markings to indicate direction of orientation or other mistake-proofing method or marking. The spray ball shall provide coverage and cleaning during routine system operation. • Human-Machine Interface/Programmable Logic Controller HMI/PLC The fermenter shall contain a human-machine interface (HMI) connected to a programmable logic controller (PLC) for monitoring and control of all Fermenter functionality and parameters. The fermenter control system shall be capable of connecting to BioCommand SCADA application for data logging and supervisory control. The HMI and control system enclosures shall meet NEMA 4X standards and shall be hardened for industrial use. Real time data shall be displayed on the HMI (and PC if/w hen connected). The fermenter shall provide a graphical interface that includes pictograms of the process, including valves, pump, agitators and all key parameters. The system shall be capable of being connected to and remotely monitored from the site SCADA system (Rockwell Automation Factory Talk) via an Ethernet connection and OPC protocol. Monitored values would include all key parameters, and general status (on, off, faulted, e-stop, active alarm condition). The control system will include engineering-level maintenance screens, which will provide manual control of all I/O, process steps, etc. The system software and design shall be consistent with 21 CFR Part 11 requirements. The vendor shall provide a 21 CFR Part 11 assessment as part of the turnover package If back-up power fails, system will mechanically fail to a safe state and shall automatically restart upon power restoration and send an alarm to document the outage. The system shall be equipped with an E-Stop that removes all potential (electrical, pneumatic, hydraulic) power from the equipment and puts the fermentor in an idle state The E-Stop will be lockable and require manual operator intervention to release the E-Stop. The E-Stop shall be easily accessible by equipment operators. Upon release of the E-Stop, the system will automatically resume all critical operations and control from the recipe current step and time after restart. • Process Control Fermenter shall be capable of simultaneous controlling the addition of up to four gases (air, O2, N2, Auxillary / Redundacy) and be e capable of introducing and controlling gas flow at a specified rate of air and O2 for dispersion in the growth medium. The Fermenter shall be capable of monitoring Dissolved O2 via a optical O2 probe. The system shall be capable of redundant O2 probes that can be switched during the process The Fermenter shall be capable of monitoring pH over the range of the process. The system will be capable of redundant probes that can be switched during the process pH probes shall be connected to the fermenter controls via a VP8 connector. Fermenter shall be capable of controlling vessel process pressure between 0 and 50 PSIG The fermenter shall be capable of sensing high and high-high levels of foam and responding with addition of anti-foam. The fermenter shall automatically monitor and control the media temperature (range: 10 - 123 ºC ). System shall be able to heat 1 ºC per minute The fermenter shall be capable of measuring the mass of the fermenter contents for weight-based control (tolerance of ± 0.5kg, static) , including feed additions, acid additions, and base additions The fermenter shall be capable of sterilizing media in place across the working volume range (30-100 L), setpoint = 123 ± 1.0 ºC. The fermenter shall be capable of maintaining sterility for a minimum period of 10 days with daily sampling for sterility testing. The system shall be designed to shield the control system hardware and sensors from electromagnetic interference The system shall provide an interlock system that will stop agitation in the fermenter in the event that the agitator seal is not being lubricated sufficiently by steam The fermenter shall be designed and programmed for automatic vessel sterilization (SIP) System will be equipped with temperature monitoring at all SIP sampling locations to verify sterilization temeperature requirements have been met. The system shall meet the following key parameters: Parameter Range O2 Air supply 0.5 VVm +/- 2% Air supply 1 VVm +/-2% Operating Temperature 18 – 80 ºC +/- 2ºC Steam Sterilization temperature 123-130 ºC +/-2 ºC pH 2 – 14 +/- 0.3 Agitation 50 – 500 RPM Pressure 0 – 50 PSI (controllable) Dissolved Oxygen 0 – 200% Operational pressure 0 - 50 psig Weight Range = dry to maximum capacity, +/- 0.5 Kg (static, no agitation) (maximum and range to be evaluated by vendor) Anti-Foam Feed Rate 0 – 100% of potential output Pump Feed Rate(s) Pumps sizing shall be evaluated by vendor during design The system shall meet the following Utility Requirements: Parameter Range Power 480 VAC, 3ph, 60Hz 120 VAC, 1 – 3ph, 60Hz Generator Backup UPS Backup for 120 VAC circuits Clean Steam 35 PSIG Plant Steam 30 - 35 PSIG Process Chilled Water 55 PSIG @ 10°C Chilled Water Return 20 PSIG maximum backpressure Instrument Air 80-100 PSIG Clean Compressed Air 80 - 100 PSIG Full Pressure, 30 – 35 PSIG Regulated Oxygen 35 PSIG, Bulk O2 System CO2 40 PSIG, Cylinder, USP Grade Nitrogen 40 PSIG, Cylinder, USP Grade