PWS

Glassware Washer System

CIN/ALP: OC-OCS-26-C-7997/OC-2026-132532 1

PERFORMANCE WORK STATEMENT (PWS)

Glassware Washer System

Food and Drug Administration (FDA)

San Juan Medical Products Laboratory (SJNLMP)

1. Background

The Food and Drug Administration (FDA), San Juan Medical Products Laboratory (SJNLMP), performs a large variety of analytical methods to analyze a wide range of drug products. These methods require the use of a broad range of analytical glassware that must be routinely cleaned using specific washing and rinsing conditions to remove chemical residues and particulate buildup.

The San Juan Laboratory requires replacement of an existing obsolete glassware washer with a new system incorporating modern technology and capabilities. Replacing the existing unit will maximize productivity, improve laboratory operations, support a safer and greener work environment, reduce operating costs, and improve operational efficiency.

2. Objective

The objective of this requirement is to acquire and install one (1) laboratory-grade glassware washer to replace an obsolete unit currently in service.

The replacement system shall provide large-capacity washing capability for laboratory glassware used in analytical testing operations. The system shall improve productivity by accommodating multiple glassware sizes and reducing the number of wash cycles required to meet daily laboratory needs.

3. Scope

The Contractor shall provide all personnel, equipment, materials, transportation, supervision, and other resources necessary to furnish, deliver, install, test, validate, and place into operation one (1) large-capacity laboratory glassware washer and all associated accessories described herein.

CIN/ALP: OC-OCS-26-C-7997/OC-2026-132532 2

The Contractor shall provide installation supervision, operational verification, training, documentation, warranty support, and all required services necessary for a complete and fully operational system.

Government-Furnished Information and Support

The Government will provide reasonable facility access and coordination necessary to perform delivery, installation, testing, validation, training, and acceptance activities associated with this requirement.

4. Performance Requirements

4.1 Glassware Washer System Requirements

The Contractor shall provide one (1) Glassware Washer System that meets or exceeds the following minimum specifications:

Physical Dimensions

• Glassware washer dimensions shall fit within the available installation space of:

o Width: 42 inches o Height: 80 inches o Depth: 33 inches

Chamber Capacity

• Minimum chamber load capacity:

o Width: 26 inches o Height: 25 inches o Depth: 26 inches

System Features

The system shall:

• Include a 316L stainless steel washing chamber.

• Accommodate two (2) loading accessories simultaneously.

• Include a programmable touchscreen controller with deviation alarms.

• Include an internal chamber light.

CIN/ALP: OC-OCS-26-C-7997/OC-2026-132532 3

• Include a USB port for transfer of usage data and audit trails.

• Include a programmable vented drying system.

• Include a drain discharge cool-down system.

• Include a loading shelf.

• Include a thermal printer.

• Include a non-recirculated heated pure water rinse system.

• Include an integrated detergent drawer capable of holding two (2) one-gallon containers with a minimum of:

o Two (2) pickup tubes; and o Two (2) low-level sensors.

• Include two (2) additional chemical pumps for chemical injection during treatments, including:

o Minimum 50 feet of tubing;

o Electrical wiring;

o Pickup tubes; and o Low-level sensors.

• Include six (6) stainless steel flanges to seal the opening between the washer and wall.

Accessories

The system shall include:

• One (1) 32-piece spindle header (up to 3 inches).

• One (1) 18-piece spindle header (up to 3¾ inches).

• One (1) Teflon glassware protective mesh.

• One (1) single-level transfer cart and assembly.

• One (1) bottom rotary spray header with:

o General-purpose basket and cover;

o Test tube rack; and

CIN/ALP: OC-OCS-26-C-7997/OC-2026-132532 4

o Petri dish rack.

• One (1) pipette header capable of washing all types of pipettes from 0.1 mL through 25 mL and accommodating up to 90 pipettes.

5. Installation and Training Requirements

The Contractor shall:

• Provide installation supervision.

• Perform system startup activities.

• Verify proper installation and operation of the system.

• Provide onsite familiarization training for two (2) to three (3) Government users.

• Provide shipping and installation services to San Juan, Puerto Rico.

• Provide inside delivery.

• Remove and properly dispose of all shipping materials, including pallets, cartons, plastics, wood, and related packing materials from Government premises.

6. Trade and Service Requirements

The Contractor shall provide equipment that is:

• Newly manufactured;

• Free from defects;

• Not used;

• Not refurbished; and

• Not previously utilized as demonstration equipment.

The Contractor shall provide all supplies, accessories, and materials necessary for installation, startup, and operation.

Upon installation, the Contractor shall demonstrate that the system meets or exceeds all performance specifications identified in the Contractor's quotation and accepted by the Government.

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Onsite installation services shall include all labor, travel, transportation, and delivery costs.

The Contractor shall provide validation of the instrument at the time of installation.

7. Warranty Requirements

The Contractor shall provide a minimum twelve (12) month warranty covering parts and labor beginning upon formal Government acceptance.

Warranty coverage shall include:

• Unlimited telephone and email technical support.

• Onsite repair services when required.

• Factory-certified replacement parts.

• Engineer labor.

• Travel costs.

• Software updates.

• Software notifications.

• Installation of replacement components.

The warranty shall include a minimum of one (1) preventative maintenance visit to ensure optimal system performance.

The Contractor shall provide access to a technical support call center Monday through Friday, at no additional cost to the Government. Technical support personnel shall possess sufficient expertise to troubleshoot and support the system.

8. Qualification and Documentation Requirements

The Contractor shall provide:

• Installation Qualification (IQ) documentation.

• Operational Qualification (OQ) documentation.

• Instrument manuals.

• User training certificates.

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• Trainer certification documentation.

The Contractor shall provide IQ/OQ certification reports that include:

• Applicable standard operating procedures;

• Manufacturer-established operating limits;

• Calibration documentation; and

• Qualification and verification reports.

All qualification and verification reports shall be submitted to the COR for review and approval.

9. Repair Service Requirements

The Contractor shall repair or replace defective components covered under warranty at no additional cost to the Government.

For warranty repairs:

• Parts shall be delivered using the fastest available method.

• Service shall be scheduled within seventy-two (72) business hours following receipt of parts and COR approval.

All replacement parts shall:

• Be supplied by the original manufacturer; and

• Be installed according to manufacturer specifications.

Upon completion of any warranty or contracted service, the Contractor shall provide a written service report to the COR or designated representative. The report shall include:

• Date of service;

• Type of service performed;

• Equipment model number;

• Equipment serial number;

• Name of field service technician;

• Description of work performed; and

CIN/ALP: OC-OCS-26-C-7997/OC-2026-132532 7

• Calibration certificate(s) for any reference standards utilized.

10. Deliverables

Deliverable Quantity Due Date

Glassware Washer and Accessories 1 Within 6–8 Weeks After Award

Installation and Startup Verification 1 Within 6–8 Weeks After Award

IQ/OQ Documentation 1 Within 6–8 Weeks After Award

User Training and Completion Certificates 1 Within 6–8 Weeks After Award

Instrument Manuals 1 Within 6–8 Weeks After Award

Inside Building Delivery and Unpacking 1 Same Day as Delivery

Disposal of Shipping Materials 1 Same Day as Delivery

11. Delivery Location and Place of Performance

Food and Drug Administration San Juan Laboratory 466 Fernández Juncos Avenue San Juan, PR 00901-3223

The Contractor shall contact the Government Point of Contact at least forty-eight (48) hours prior to delivery.

Deliveries shall be made Monday through Friday, excluding Federal holidays, between the hours of 8:00 a.m. and 4:00 p.m. local time.

Any delivery scheduled on a Federal holiday shall occur on the next business day.

Delivery shall include inside placement at the designated installation location.

Inspection and Acceptance

Inspection and acceptance shall occur at the FDA San Juan Medical Products Laboratory upon successful delivery, installation, operational verification, completion of required training, submission of required documentation, and Government determination that all contract requirements have been satisfactorily fulfilled.

CIN/ALP: OC-OCS-26-C-7997/OC-2026-132532 8

The Government reserves the right to inspect all supplies and services provided under this contract to ensure compliance with the requirements of this Performance Work Statement (PWS). Acceptance shall be made by the Contracting Officer's Representative (COR) or designated Government representative.

This keeps the PWS cleaner and avoids renumbering Sections 12–14. For this type of requirement, that's the approach I would use.

12. Government Points of Contact

Contracting Officer (CO) Name: Iris Johnson Office: (301) 796-3353 Email: Iris.Johnson1@fda.hhs.gov

The Contracting Officer's Representative (COR) information will be given at the time of award.

13. Hours of Availability

Contractor personnel performing onsite services shall be available during normal Government business hours:

Monday through Friday 8:00 a.m. – 4:30 p.m. Local Time

The Government is closed on all Federal holidays unless otherwise authorized by the

COR.

14. Period of Performance

The Period of Performance shall begin upon contract award and continue through completion of all required deliverables and warranty support.

The glassware washer system shall be delivered, installed, tested, validated, and operational within six (6) to eight (8) weeks after contract award.

Warranty coverage shall continue for a minimum of twelve (12) months following formal Government acceptance or longer if offered by the manufacturer.

mailto:Iris.Johnson1@fda.hhs.gov