Attachment I - Statement of work .pdf

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ATTACHMENT I

STATEMENT OF WORK (SOW)

Semiautomatic Aerosol Propellant Filler for pMDI Two- Stage Formulation

A. Background The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Testing and Research (OTR), conducts research to advance pharmaceutical manufacturing technologies that improve product quality, manufacturing reliability, supply chain resilience, and patient access to safe and effective medicines.

One of FDA's research priorities is the evaluation and implementation of advanced pharmaceutical manufacturing technologies, including inhalation drug delivery systems and spray-dried pharmaceutical products. To support this mission, FDA requires a semiautomatic aerosol propellant filler system capable of filling pressurized metered-dose inhalers (pMDIs) utilizing both traditional and next-generation propellants.

The Government intends to acquire a Parmasol Semiautomatic Aerosol Propellant Filler System distributed through Aerosol Machinery Solutions, LLC, or an equal product that meets all requirements identified in this Statement of Work (SOW).

B. Objective The objective of this requirement is to procure a complete semiautomatic aerosol propellant filling system, including associated accessories, installation, validation support, training, and warranty services, for use in pharmaceutical inhalation product development and manufacturing research.

The resultant contract shall be a Firm-Fixed-Price (FFP) purchase order.

C. Scope of Work

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The Contractor shall furnish all labor, materials, equipment, transportation, supervision, and other resources necessary to provide a complete and operational semiautomatic aerosol propellant filling system meeting the requirements of this SOW.

The Contractor shall deliver, install, test, and provide user training for the equipment at the FDA facility identified herein.

D. Salient Characteristics and Technical Requirements D.1 Pressure Filler System The pressure filler shall be suitable for pharmaceutical manufacturing applications and shall meet the following minimum requirements:

Mechanical Configuration

• On-column design with base plate

• Stainless steel pneumatic control enclosure

• Adjustable dosing cylinder capable of dispensing from 0.5 mL to 20 mL

• Diaphragm shut-off valve

• Oil-free operation

• Quick-change product aggregate assembly

• Quick-release couplings on hose connections and filling nozzle

Materials

• All product-contact components shall be manufactured from AISI 316L stainless steel

• Material certificates compliant with EN 10204-3.1 shall be provided for all product-contact stainless steel components

Accessories

The pressure filler shall include:

• Filling head insert for one 20 mm valve type

• Container centering device

• Two-hand safety protection guard

• Set of special tools

• Set of spare parts

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D.2 Crimper Assembly The system shall include a pharmaceutical manufacturing crimper meeting the following requirements:

Configuration

• On-column design with base plate

• Stainless steel pneumatic control enclosure

• Large crimping head (2002/740 equivalent) suitable for 20 mm valves

• Oil-free operation

Adjustability

• Adjustable crimp height

• Adjustable crimp diameter

• Adjustable container height

• Adjustable container diameter

Accessories

The crimper shall include:

• Crimping tong and valve stop suitable for one 20 mm valve type

• Two-hand safety protection guard

• Container centering device

• Set of spare parts

• Set of special tools

D.3 Crimp Height Measuring Gauge The Contractor shall provide a crimp height measuring gauge meeting the following requirements:

• Suitable for measuring crimp height on aerosol containers with 20 mm openings

• Digital display

• Suitable for use in a safe area environment

• Calibration piece included

• Calibration certificate included

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D.4 Propellant Pump Assembly The Contractor shall provide a propellant pump meeting the following minimum requirements:

Performance

• Capacity up to 15 liters per minute

• Maximum outlet pressure of 2,000 kPa (20 bar)

• Pneumatic control system

Materials

• Product-contact components manufactured from AISI 304 stainless steel

• Pressure gauge and applicable product-contact components manufactured from AISI

316L stainless steel where specified

Compatibility

The pump shall be compatible with liquified propellants including:

• Hydrofluoroalkane (HFA)

• Liquefied Petroleum Gas (LPG)

• Dimethyl Ether (DME)

Included Components

The Contractor shall provide:

• Inlet filter with 150-micron mesh

• Outlet pressure gauge

• Set of special tools

• Set of spare parts

• Hose and connection kit

• Filter unit with:

o 5-micron pre-filter o 0.1-micron sterile filter

• Filter cartridge (5 micron)

• Filter cartridge V12640-01 or equivalent (0.1 micron)

• Pressure gauge V12632/01 or equivalent

E. Contractor Responsibilities

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The Contractor shall:

1. Provide all packaging, handling, transportation, and shipping.

2. Deliver all equipment to the Government facility.

3. Install all equipment and accessories.

4. Perform operational testing and startup activities.

5. Provide Factory Acceptance Test (FAT) documentation.

6. Provide validation documentation.

7. Provide validation execution support.

8. Provide user/operator training.

9. Provide all manuals, operating instructions, and maintenance documentation.

10. Provide warranty support as specified herein.

F. Delivery Requirements The Contractor shall deliver all equipment within:

90 Calendar Days After Award

Delivery shall be coordinated with the Contracting Officer's Representative (COR).

G. Place of Performance U.S. Food and Drug Administration

Center for Drug Evaluation and Research

Office of Testing and Research

10903 New Hampshire Avenue

Laboratory WO64, Room 1083

Silver Spring, MD 20993

H. Training Requirements

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The Contractor shall provide onsite operator training following installation.

Training shall include:

• System operation

• Safety procedures

• Preventive maintenance

• Troubleshooting procedures

• Cleaning and maintenance requirements

Training materials shall be provided in electronic format.

I. Warranty Requirements The Contractor shall provide a minimum one-year warranty commencing upon Government acceptance.

The warranty shall include:

• Parts

• Labor

• Travel

• Onsite repair services

• Technical support

The Contractor shall respond to warranty service requests within two business days.

J. Deliverables Deliverable Due Date

Equipment Delivery Within 90 calendar days after award Installation Completion Within 10 business days after delivery Factory Acceptance Documentation At Installation Validation Documentation At Installation Operator Training Within 5 business days of installation Warranty Documentation At Acceptance Operations and Maintenance Manuals At Installation

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K. Inspection and Acceptance The Government shall have thirty (30) working days following installation and operational testing to inspect and verify the equipment.

Acceptance shall occur when the Government determines that:

• Equipment is operational;

• Equipment meets all contract requirements;

• Training has been completed; and

• Required documentation has been received.

L. Period of Performance The period of performance shall begin upon contract award and continue through completion of all warranty obligations.

The anticipated term of the resultant contract shall be:

Date of Award through One (1) Year After Award

M. Contract Type The Government anticipates the award of a:

Firm-Fixed-Price (FFP) Contract for the supplies and services identified in this Statement of Work.

N. Program Administration Contracting Officer Technical Representative ** To Be determined **

Contracting Officer - Michele Jackson Michele.jackson@fda.hhs.gov mailto:Michele.jackson@fda.hhs.gov

N. Program Administration