Attachment 1 - SOW.pdf

Statement of Work Dual Dissolution Bath with Autosampler System for the San Juan Medical Products Laboratory

Background

The Food and Drug Administration (FDA), San Juan Medical Products Laboratory (SJNLMP) needs to replace existing obsolete model dissolution baths used for routine sample analysis with a new dissolution bath system. The system in use needs to maintain cGMP/cGLP, ISO/IEC 17025-2017, ISO 9001:2008, and 21 CFR 11 standards for use as analytical equipment under the current accreditation.

The system is used to analyze medical product samples using specific protocols and methods established by USP, internal FDA programs, DOD SLEP, and the FCC program.

As a Medical Product Specialty Laboratory, the laboratory uses dissolution technology to analyze a variety of drug samples. The San Juan Laboratory needs to update the existing dissolution bath system to newer models with modern capabilities that include extended-release testing, profile sample analysis, programming and traceable reporting. The new requested system is bathless, and includes and autosampler, PC workstation, controller software, and modern serialized instrument components. The older dissolution bath system has been discontinued by the manufacturer.

Objectives

To obtain a fully functional modern dissolution system controlled by software with improved analytical capabilities to replace an existing obsolete system more than 15 years old.

Scope

The Contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). Dual dissolution bath system with autosampler and software to replace an older dissolution system.

Requirements

All the following system requirements are minimum requirements:

• The dissolution system shall comply with the following quality requirements:

o ISO/IEC 17025-2017 https://www.iso.org/standard/39883.html, https://www.iso.org/standard/66912.html o ISO 9001:2008 https://www.iso.org/standard/46486.html o 21 CFR Part 11 Compliance Features Available https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm o USP, cGMP/cGLP https://login.usp.org/cas/login?service=http%3A%2F%2Fonline.uspnf.com%2Fcas%2Flo gin

• The dissolution system shall include the following salient requirements:

o Two bathless 115V dissolution instruments that contain:

https://www.iso.org/standard/39883.html,%20https:/www.iso.org/standard/66912.html https://www.iso.org/standard/39883.html,%20https:/www.iso.org/standard/66912.html https://www.iso.org/standard/46486.html https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm https://login.usp.org/cas/login?service=http%3A%2F%2Fonline.uspnf.com%2Fcas%2Flogin https://login.usp.org/cas/login?service=http%3A%2F%2Fonline.uspnf.com%2Fcas%2Flogin

Six spindle drives Color touch screen display Quick change paddles and baskets Automatic height adjustment Twelve wireless resistance temperature detector (RTD) shaft assemblies, serialized and with certification Two RTD power packs for 6 positions Twelve paddle blades serialized with certification Vessels 1L amber glass, serialized with certificate Twelve vessel covers o Dissolution system 115V autosampler

Uses precision syringe pumps for accurate sampling Optimized pathway <5 mL internal volume Capability of sampling from two dissolution baths Capability of sampling from the same or different (independent) methods Configuration with six positions Includes media replacement and recycling 100 method storage Multiple user security Time point sampling as soon as 5 minutes Audit trail o Autosampler filter system

Two filter systems (one for each bath) Capable of utilizing 25 mm syringe filters Two 8 position test tube racks for sample collection Two 8 position HPLC vial racks for sample collection Two Connection cables (RS-232) Twelve sample probes for use with filters Twelve 90-degree elbow fitting for sample probes 2 pack (100 each) filter disks 45 µm 2 pack glass test tubes 16 mm x 100 mm o Controller Software and Workstation

PC Station and Monitor Win 11 One License Capable of controlling dissolution baths, autosampler and programming Capable of reporting results 21 CFR Part 11 compliant USB Communication Hub and Cables (USB and RS232) for all connections o The system shall include the current Instrument Controller Software

Instrument License Current Instrument Firmware

• Delivery, Installation and Service o Onsite installation of the entire system shall be included and inclusive of labor, delivery, and travel costs.

o System installation shall occur no later than 90-days from the date of award.

o Inside delivery, setup, and installation, cleanup (remove boxes and packing) of the area at the place of performance is required.

o The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

o Standard kits for operational qualification and performance verification (OQ/PV) shall be included.

o Installation of hardware and software shall be conducted by factory certified service personnel.

o The vendor shall demonstrate upon installation that the system meets or exceeds all performance specifications which have been included in the vendor’s response and/or used as evaluation criteria for award. The following shall be demonstrated at the time of installation:

The contractor shall demonstrate that all modules start up properly, are correctly installed and connected.

o Shall include Hardware IQ/OQ with Performance Verification.

o Shall include Software IQ/OQ and testing of basic functional specifications and Chapter

21 CFR part 11.

o The vendor shall provide IQ/OQ electronic documentation of Software and Hardware.

o The vendor shall include a minimum of one preventative maintenance visit for the KFT to ensure the instruments are functioning at peak performance.

• Warranty o The entire system shall be warranted for parts and labor for a minimum of 3-year limited warranty from date of formal government acceptance.

o The warranty shall include unlimited telephone/e-mail support for questions regarding operation. On-site response time for repairs during the warranty period shall be no more than 72 hours, if needed.

o Warranty coverage shall include all non-consumable items and parts supplied ensuring proper functioning.

o As needed, factory-certified replacement parts, engineer labor and travel costs, software updates, notifications, and installation shall be included in the warranty plan to ensure maximum system operational readiness.

o The warranty plan shall include a minimum of one subsequent preventative maintenance visit to ensure the instruments are functioning at peak performance.

• Training o Onsite familiarization training for 3-5 user shall include basic system operation and routine maintenance.

Trade and Service Specs

• Equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration.

• The Contractor shall provide a minimum of a three-year manufacturing warranty for all manufactured equipment and parts. The warranty shall be included with the equipment and not separately priced. The warranty shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an Original Equipment Manufacturer (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.

• Instrument operators shall have access to a technical representative call center at no additional charge, for technical assistance and troubleshooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

• The supplier shall provide training and validation of the equipment and software on site at the time of installation. Sufficient familiarization training for 3-5 users at onsite location will be provided, such that operators may independently operate the instrument and with increased familiarity and proficiency. The training shall include manuals and any consumables to be used during training.

• The Contractor shall provide installation qualification with an employee who can provide proof of installation qualification/operation qualification (IQ/OQ) certification. The qualification and verification report shall include the standard operating procedures and the allowed manufacturer limits for the instrument. A copy of the calibration report and the qualification and verification report(s) shall be reviewed and approved by an FDA representative before installation of the equipment and execution of protocols.

• Inside delivery, disposing pallets, boxes, and any associated garbage, and unpacking the equipment and inventory of parts with a lab representative.

Deliverables or Delivery Schedule

Deliverable Quantity Due Date Dual Bathless Dissolution System with AutoSampler and Software (system package)

1 Within 6-8 weeks after date of award

Installation and Operation Qualification documentation 1 Within 6-8 weeks after date of award

Familiarization Training 3-5 users Within 6-8 weeks after date of award

Instrument and Software User Manuals 1 Within 6-8 weeks after date of award

Place of Performance

Food and Drug Administration San Juan Medical Products Laboratory 466 Fernandez Juncos Ave, San Juan, PR 00901-3223

POCs: To be identified at time of award.

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). The contractor shall provide at least a 2 week notice for installation, set-up, and training date(s). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. Delivery must be inside the facility. Contractor staff must have photo ID to enter building. Unless otherwise specified, all reports or copies of service reports shall be delivered to the COR identified in each Order at time of service.

These reports shall detail services, locations of performance and dates performed.

Period of Performance

The Period of Performance begins the date of contract award execution and continues for three years (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.

Hours of Operation

The contractor is responsible for conducting business, between the hours of 8:00 AM – 4:00 PM Monday through Friday except Federal Holidays or when the Government facility is closed due to local or nation emergencies, administrative closings, increment weather, or similar Government directed facility closings.