Sources sought -121770A.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN

INFORMATION ONLY. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR

PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT.

NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH

PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY

FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE

ACCEPTED REQUESTING AN RFQ PACKAGE OR SOLICITATION. THERE IS NO RFQ

PACKAGE OR SOLICITATION. IN ORDER TO PROTECT THE PROCUREMENT

INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS

ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF

CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS

WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the New York Laboratory Medical Products (NYLMP) in order to determine if there are existing small business sources capable of providing one isolator.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Nina.Montgomery@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background

The U.S. Food and Drug Administration (FDA), New York Laboratory Medical Products (NYLMP) in the Office of Regulatory Science (ORS), Office of Medical Products and Specialty Lab Operations (OMPSLO), located at 158-15 Liberty Avenue, Jamaica, NY, 11433 is experiencing a significant growth in the demand for sterility testing. As part of NYLMP commitment to maintaining the highest standards of quality cGMP/cGLP, ISO/IEC 17025-2005, ISO 9001:2008, and 21 CFR 11, which are crucial for meeting accreditation requirements, there is a recognized need to enhance NYLMP’s infrastructure by incorporating isolators. The recent surge in demand has strained the lab’s existing resources, potentially causing bottlenecks in our analytical processes.

To effectively address this challenge and continue to deliver accurate and timely results, it is imperative to acquire one isolator to enhance NYLMP analytical capabilities. This strategic move will not only alleviate the current strain on resources but also enhance NYLMP’s capabilities in sterility analysis, ensuring continued adherence to the highest industry standards

Purpose mailto:Yolanda.rankin@fda.hhs.gov

As a Medical Products Laboratory, the New York Laboratory Medical Products requires a diverse range of analytical instrumentation that provide the versality needed to perform a wide variety of analytical methods. The purpose of this contract is to acquire one isolator, specifically designed to enhance and support sterility analysis processes within NYLMP. These isolators will play a crucial role in maintaining a controlled environment for handling and analyzing sterile materials, ensuring the precision and reliability of sterile testing. The acquisition of these isolators aims to streamline NYLMP’s sterility analysis workflow, thereby optimizing operational efficiency. This improvement will allow our skilled personnel to shift their focus from labor-intensive tasks to more critical aspects such as data interpretation and quality assurance.

Scope

The Contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). The Contractor shall provide one isolator that support current United States Pharmacopeia USP <71> Sterility Testing of Pharmaceutical Products.

I. MINIMUM SALIENT REQUIREMENTS

All the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government prior to purchase.

**Offerors’ quotes shall address and meet or exceed each of the salient requirement to be considered for award**

• The Isolators shall comply with the following requirements:

o Specifications

Modular rigid-wall with fast bio-decontamination solutions Full traceability and compliant with FDA 21 CFR Part 11 Upwards opening door with optional transfer hatch and main chamber Validated process control providing connectivity and traceability Safe and easy access to the chamber and hatch One (1) 4-Glove Rigid Isolator with attached hatch, equipment shall be equivalent to the Getinge 4-glove Isoflex R with BioDecon Hatch isolator.

Fitted with a decontamination system with integrated H2O2 generator capable of producing and delivering vaporized hydrogen peroxide to decontaminate work surface, at minimum, by a 6 log reduction of spores.

Fitted with a Glove Leak Tester with glove extenders.

Equipped with a viable particle counter.

Ability to easily remove solid waste through a passage.

Equipped with a port to connect to a liquid waste collection vessel.

Must be able to produce and store alarm reports with can be transferred by a USB device, or similar.

120 Volt, 30 amp voltage FDA 21 CFR Part 11 compliant User training

• Comprehensive user manuals and training for at least four personnel using the isolators, emphasizing proper aseptic techniques and maintenance procedures. Training may be provided at our laboratory or at manufacturer facility.

• Suppliers and consultants shall be shadowed by NYLMP Micro team to enable enough knowledge to be accumulated to assure the safe routine operation and requalification of the system. This knowledge should then be cascaded to all people routinely involved.

• Emergency protocols for power failures or other unexpected events, ensuring the safety of personnel and the preservation of sterile conditions.

Installation

• Setup, configure, and install all components of instrument delivered to include installation qualification and Operation Qualification by vendor

Workstation software and license – Data compatible with lab’s Enterprise Lab Notebook

Air Handling and Filtration

• High-efficiency particulate (HEPA) filters used to remove particles from the incoming air

• Unidirectional or turbulent airflow to prevent the ingress of contaminants

• Adequate air filtration to maintain aseptic conditions

• Ability to test HEPA filters for leaks

Glove System

• Integral glove system with a smooth, easily cleanable surface

• Gloves made of materials that do not shed particles and are resistant to disinfectants

• Ensure the integrity of gloves used in the isolators, with regular checks and easy replacement procedures to prevent breaches

Validation and Compliance

• Ensure that the isolators are designed, installed, and validated according to relevant regulatory standards and guidelines (e.g., GMP, ISO standards)

• Performance Qualification protocol Integration with analytical Equipment

• Provide integration capabilities for analytical equipment to be used inside the isolators, ensuring a seamless workflow for sterility analysis, for example rods, hooks, and shelves.

• Fitted with a Millipore Steritest Symbio ISL pump with foot switch and accessories to perform USP <71> Sterility analysis using the Millipore Steritest system.

Manufacturer to provide one annual preventative maintenance visit with the option to add up to 4 additional years of service.

II. TRADE AND SERVICES SPECS

• The Isolators must be a newly manufactured unit, not used and refurbished or previously used for demonstration. The Government must be able to expect routine customer service and technical support to be available from the vendor during the equipment’s lifecycle.

• The government requires a minimum one-year Original Equipment Manufacturer’s warranty on electronic components which shall include at a minimum: coverage on all non-consumable items and parts supplied and unlimited on-site service visits.

All replacement parts, engineer labor and travel costs. The warranty begins on the date of formal government acceptance.

• The Contractor is responsible of doing the actual installation and dispose pallets, empty boxes, and any associated garbage off site of FDA facilities the day of the delivery.

• The vendor shall provide to the user documentation of the qualification upon installation.

• The vendor shall demonstrate upon installation that the system meets or exceeds all salient characteristics which have been included in the vendor’s response and/or used are evaluation criteria for award. The instrument shall not be accepted until those characteristics have been met.

• All solutions and accessories for instrument maintenance, calibration and qualification must be provided by vendor at time of installation.

• Contractor shall provide on-site familiarization introductory on-site training for 15 users.

• Installation and familiarization shall be performed by a certified and trained engineer. Contractor to provide any necessary manuals and/or consumables to be used during training.

Repair Service (during warranty period)

• The Service Technician under the service agreement shall repair or replace any part or parts that prove to be defective at no additional charge to the Government.

• The Contractor shall plan for the fastest delivery and will resume work upon receipt of parts within 72 business hours (3 days) or a mutually agreed upon time frame.

• All parts replaced will be new replacement parts which meet the original manufacturer's specifications (no refurbished or third-party parts).

• The Service Technician under the service agreement shall agree to unlimited repair service of any part or problem at no additional charge to the Government.

This includes replace any part or parts that prove to be defective at no additional charge to the Government and includes upgrading any software etc. so that the system maintains its original functionality and intended purpose.

• Equipment repair and maintenance work is performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts.

• Parts, labor, and travel/per-diem costs for PM and repairs shall be included in the price of the service agreement.

Documentation

• Equipment manuals and instructions are included with the unit.

• IQ/OQ documentation

• Documentation of vendor provided training.

• Performance Qualification protocol

Records and Reports

The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA PROJECT OFFICER and Contract Specialist, not later that the 5th workday following the end of each month, summarizing

Imboden, Louis Any training, repair and qualification documentation that will be required all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed).

Table 1. Deliverables/Schedule Base Year

Deliverable Quantity Due Date Isolator System 1 Within 35-40 working days after date of award. Minimum 35 acceptable working days

IQ/OQ/PQ 1 Within two (2) weeks after Government acceptance of delivered item Training 8 Within two (2) weeks after

IQ/OQ/PQ

Service Reports As needed At time of installation or immediately thereafter and only during months when warranty work is performed

One-year manufacturer’s warranty 1 Begins at Government acceptance of delivered item

Security

If the vendors are entering the building, the following information must be collected and given to security on a visitors form before their visit. Vendors should ensure they have a government issued ID to enter the facilities.

1. Company Completing the Delivery

2. Name of Visitors Entering Building

3. License Plate Number

4. Vehicle Make

5. Vehicle Model

6. Date of Arrival

7. Time of Arrival

8. Internal FDA Contact Number

Shipping Destination/Place of Performance

Food and Drug Administration New York Laboratory Medical Products 158-15 Liberty Avenue Jamaica, NY 11433

Vendor must call the Government POC at least 48 hours prior to delivery. Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays see below between the hours of 8:00 a.m. and 4:00 p.m. in accordance with the delivery location time zone (Eastern Time, Central Time, or Pacific Time). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. Delivery must be inside the facility.

If the vendors are bringing the equipment inside of the building, a certificate of insurance (COI) should be provided to the POC and forwarded to Hines. If the dimensions of the items are available that information should also be provided to Hines.

The COI should contain the following information.

Include the following on the certificate of insurance:

NAMED AS ADDITIONAL INSURED:

HINES GS PROPERTIES, LLC. & FDA QUEENS L.P

CERTIFICATE HOLDER SHOULD BE:

HINES GS PROPERTIES, LLC.

& FDA QUEENS, LP

158-15 LIBERTY AVE.

JAMAICA, NY 11433

ATTN: PROPERTY MANAGEMENT OFFICE

If the vendors are leaving the items on the loading dock and not entering the building a COI is not needed.

Period of Performance

The Period of Performance begins the date of contract award execution and continues for one year (or longer depending on how long the OEM offered warranty period is) from the date of formal government acceptance. Instrument to be delivered no later than 6-8 weeks after date of award.

Delivery of one system as outlined in the Delivery schedule.

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before August 25, 2024 by 10:00am (EST) at the Food and Drug Administration, Attn: Nina Montgomery, email nina.montgomery@fda.hhs.gov. Reference: 75F40124Q121770A.

mailto:nina.montgomery@fda.hhs.gov.

Imboden, Louis In the deliverable section it states deliver 30-45 days from date of award. Recommend breaking delivery and PMA, qualifications into different POP based on labs need.

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 pre‐solicitation synopsis and solicitation may be published in 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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.