Draft_SOW_CDER-2025-126411.pdf

DRAFT

Statement of Work (SOW)/Performance Work Statement (PWS)

A. BRIEF DESCRIPTION OF REQUIREMENT/STATEMENT OF NEED:

CDER’s Office of Pharmaceutical Quality Research (OPQR) requires the purchase of rapid microbial limit detection equipment capable of confirming the presence of bioburden contamination for microbial quality control testing using membrane filtration with ATP detection. This system will expand our current capabilities to test the microbial quality of purified bulk drug substance and final formulated drug product as well as support research into the robustness of rapid/alternative microbial detection methods used by industry. OPQR currently owns and operates a 2nd gen Milliflex Oasis filtration pump (MMSYSTMM2) which uses specific filter funnels and microbial culture accessories to fit the pump head. The reqired membrane filtration + ATP detection system - Milliflex Rapid System 2.0 (Millipore Sigma)-must have an autospray station and detection tower compatible with this existing pump and filter membranes.

B. SYSTEM DESCRIPTION:

System must have standard 110V/60Hz U.S. plugs.

Item Part # Quantity

HARDWARE & ACCESORIES

Milliflex Rapid 2.0 Detection System kit

(inl. 1xMXRP2SPRKT and

1xMXRDP2DT00) without power supply

MXRDP2KT01 1.00

MFR 2.0 & sprayer power supply - US MXRPWRSPUS 1.00

Milliflex Oasis® filtration pump without filtration head WITH power supply (US)

MMSYSTMM2 1.00

Milliflex Oasis filtration head, 2nd generation

MHEADMM2 2.00

Stainless steel tool used to perform control test of Milliflex Rapid hardware system

P0SIC0NT1 1.00

Milliflex Rapid Cleaning/Decontamination

Kit. Includes: Rinsing agent (4 bottles/pk), Cleaning agent (4 bottles/pk), Decontamination agent (1 bottle/pk), Luer-Lock caps (10/pk), Vial adapters

(9/pk). For 20 cleanings and 2 decontaminations.

MXRPCLKT1 1.00

Milliflex Rapid Reagent Kit (100 tests) MXRPBLRST 1.00

Milliflex Oasis® rapid - 100 mL funnel,

0.45 μm white plain, PVDF Durapore® membrane (24)

MMHVMFX24 4.00

Milliflex Oasis® media plate prefilled with

TSA Agar (48)

MMSMCTS48 2.00

Milliflex Oasis membrane support removal tool

MMSUPREMV 1.00

Milliflex Oasis internal flow sanitization kit MMSANKIT1 1.00

Installation IQ/OQ, training

Milliflex Rapid V2.0 with Milliflex Oasis e-Protocol Service for IQ & OQ

MXRPIQOQEP 1.00

On-site Milliflex Rapid System IQ/OQ and

PQ consulting+ training (up to 3 days) on equipment use and maintenance

RSVALID11 1.00

On-site Milliflex Oasis pump IQ/OQ + training on equipment use and maintenance.

BSVALID11 1.00

Delivery & Installation 1.00

C. PERFORMANCE PERIOD:

Period of performance will be one year from the delivery and installation of the instrument.

D. PERFORMANCE REQUIREMENTS:

To meet the purpose and objective of this requirement, the Contractor shall provide the following:

General Service Requirements:

• Only certified field technicians must be used for installation and training

• Scheduling must be Monday-Friday between the hours of 9am-4pm.

• Scheduling to be coordinated through the TPOC on the contract

• All technicians must have a valid U.S. Driver’s license for entry through security

E. DELIVERY REQUIREMENTS

Receipt of all equipment, accessories, installation, and training must be guaranteed <45 days after award date unless otherwise postponed by the FDA.

a. Accessories and warranty

i. Proposal should include all necessary starter kits, pumps, tubing, and consumables required for initial use

b. Delivery, Installation, and Training:

i. On-site training and installation should be included in price

1. Installation will include setting up machine and performing installation and operational qualification (IQ/OQ).

2. Training to include on-site application training or no more than 3 days

3. Period of Performance should cover all parts and installation for at least 1 year after completion of all IQ/OQ.

ii. The vendor shall provide shipping, handling and inside delivery to the individual(s) and delivery location outlined below in Section 5

Shipping/Destination.

iii. End user applications training should be delivered at the time of installation by a qualified individual. Training should not be unnecessarily delayed or postponed by the Contractor.

iv. At least 2 weeks prior to anticipated delivery date, a pre-installation planning meeting between FDA laboratory staff receiving the equipment and person(s) responsible for delivery, installation, IQ/OQ, and equipment training should take place to confirm tasks, deliverables, and schedules of both parties.

F. SHIPMENT/DESTINATION:

on-site at CDER’s facilities in:

10903 New Hampshire Ave

Building 72, Second floor labs

Silver Spring, MD 20993

The FDA’s Technical Point of Contact (TPOC) will approve all tasks and deliverables.

For all on-site maintenance, the Contractor’s personnel are required to report to the security guards at the White Oak Building 75, 10903 New Hampshire Ave, Silver Spring, MD 20993, who will contact the TPOC or his or her designated FDA employee. The Contractor’s personnel must be escorted by the TPOC or his or her designated FDA employee at all times while working on-site under this order. The Contractor shall perform all on-site maintenance service during the hours of 9:00 am to 5:00 pm ET, Monday through Friday, unless otherwise indicated by the TPOC.

The TPOC will be responsible for determining the acceptance of the work that is completed.