Copley Inhaler Testing Kit

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform the potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement, to determine the method of acquisition, and availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. For equipment/supply requirements, responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule). Background: The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting, and making medical discoveries that improve people's health and save lives. Many programs within NCATS enable research collaborations to advance candidate therapeutics for both common and rare diseases into clinical testing. One of the focuses of the DPI, TDB, is to partner with researchers to generate preclinical data and clinical-grade material for use in Investigational New Drug (IND) applications to a regulatory authority. To accomplish these goals, a brand-new formulation laboratory dedicated to preclinical research was opened in the fall of 2023. In the new laboratory, scientists will research formulation and manufacturing processes to optimize products composition, dosage form, and delivery system to ensure that they are safe, stable, and effective. Specialized instruments essential for formulation development include equipment for formulation preparation, analytical assay, and stability studies. Moreover, the newly established formulation laboratory will be responsible for producing small-scale engineering batches of the studied drugs. The expertise and insights gained from these manufacturing processes and analytical tests will be shared with our collaborators to ensure the successful production of high-quality, GMP-compliant formulations suitable for human consumption in clinical trials. Furthermore, this system will be used to assist in the formulation development of lead APP candidates and other drug substances into phase I clinical trials. Inhalation therapy has become a cornerstone in the management of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis. It has also been utilized to deliver centrally acting medication such as pain analygesic and endocrine compounds. The efficacy and safety of inhalation products heavily depend on the performance of the inhaler device itself. Therefore, investing in comprehensive inhaler testing kits, such as those offered by Copley Scientific Limited, is crucial for ensuring the quality, reliability, and regulatory compliance of these essential medical devices. Purpose and Objectives: The purpose of this requirement is to acquire a Copley Inhaler Testing Kit. Specific Requirements: The specific requirements are listed below: - HCP6 High Capacity Pump 120V/60 Hz: designed for use in the testing of MDIs, DPIs, nebulisers and nasal products in accordance with the specifications laid down in the Ph. Eur. and USP. - Critical Flow Controller TPK 100i Rev Uni Voltage: designed to measure the pressure drop across the device and control the flow conditions during testing. - Flow Meter DFM 2000, 200L/min Air O2 N2 110V: Capable of measuring volumetric flow and calibrated for exit flow as opposed to inlet flow. - ADAPT 4043/DFM2000 to IP/DUSA (MSP): Adaptor for Flow Meter DFM 2000 - "NGI+" Next Gen Impactor: high performance, precision cascade impactor suitable for the APSD characterisation of all types of OINDPs. Ideal for testing at all flow rates specified in the relevant pharmacopoeias. - Induction Port NGI USP Type: Designed for the measurement Adapter can be placed between the inhaler and the NGI induction port to measure the pressure drop (P1) over the inhaler under test in the absence of a DUSA for DPIs. - Cup Set/8 (2Lrg/6Sm) for NGI: Sample collection cups - NGI Cup Tray Standard: For the convenient storage of a full set of NGI Cups, protecting the critical surfaces from inadvertent damage and dust collection when not in use. - Preseparator NGI Nickel-Coated Insert: to catch any powder boluses and large non-inhalable particles. Offeringhigh capacity, high efficiency, two-stage separation, the NGI Preseparatorprovides a sharp and reproducible cut-point of between 10 and 15microns depending on flow rate. - Adapt OInhal RS01 MOD7 DPI to IP/DUSA: Adaptor for IP/DUSA tube. - GENTLE ROCKER GR200I: Agitates the NGI Collection Cup Tray in a controlled, repeatable manner to ensure complete dissolution of the active drug prior to analysis. - DOC IQ/OQ GENTLE ROCKER GR200i: Performance test and qualification. - Kit DUSA-DPI Tecapro PTC Silic: Dose Uniformity Sampling Apparatus measurestotal amount of drug emitted from the drug device that is available to the user, when the device is actuated correctly. - Tub DUSA-DPI w/o P1 w/oCapTec: DUSA accessories - Cap Rins DUSA-DPI Tec Silic: DUSA accessories - Inhal Test WorkSta-Baseplate and Upright: Baseplate to support Inhaler Testing Workstation. - Holder Inhal Test Worksta DPI DUSA: holder for Inhlation Testing Workstation. - Holder Inhal Test Worksta DFM2000: holder for Dose Flow Meter. - DUSA Shaker w/o Coll Tubes DTS100i Univ: Holding up to 21 MDI DUSA collection tubes, the DUSA shaker automates the internal rinsing of the tubes to ensurefull, fast and repeatable drug dissolution and drug recovery from internal surfaces. - Doc IQ/OQ DUSA Shaker: Performance and qualification for the shaker - Doc IQ/OQ Inhaler Test Systems: Performance and qualification for the Inhaler test system - Trav IQ/OQ Dom 1st Day Inha Prod: Travel for performance, qualification testing, and training for day 1 - Trav IQ/OQ Dom 2nd/Sub Day Inha Prod: Travel for performance, qualification testing, and training for day 2 - Throat Albert Ideal ADULT Alum: Adult throat and lung simulator - Adapt FlowMeter to AIT Adult: Adaptor for Albert Idealised Throat - Inlet Cap/Outlet Adapt AIT Adu: Adaptor for inlet and outlet for the adult Albert Idealised Throat - Throat Albert Ideal CHILD Alum: pediatric throat and lun simulator - Adapt FlowMeter to AIT Child Version: Adaptor for pediatric Albert Idealised Throat - Inlet Cap/Outlet Adapt AIT Chi: Adaptor for inlet and outlet for the pediatric Albert Idealised Throat - Glass Fiber Filters, 47 mm, Pkg 100 - Sftwr Inhalytix 3-User License - PC: Inhalytix Software licence for three user Anticipated Delivery Date period of performance: 8-14 weeks after receipt of award In case domestic sources are available and capable of fulfilling the Government's need, and a future solicitation is published, the Government will use evaluation preferences in accordance with FAR 25. Buy American Clauses: - FAR 52.225-2, Buy American Certificate (Oct 2022) Capability statement /information sought: Companies that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2 x 11 paper size, with 1 top, bottom, left and right margins, and with single or double spacing. The information submitted must be in an outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Morgen Slager, Contract Specialist, at e-mail address Morgen.Slager@nih.gov. The response must be received on or before July 15, 2024, at 2:00 pm, Eastern Daylight/Standard Time. - Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).