SOW_.pdf

Class 100,000 Clean Room at FCI Beaumont

Scope of Work

SECTION A

Contractor shall provide all labor, materials, and equipment to build out an ISO 14644 compliant Clean Room as described below. Contractor will be responsible for complying with all regulations, policy, laws, standards, etc., of federal, state and local governments that apply to the construction of a Clean Room. SITE VISIT WILL BE

MANDATORY. The contractors will be responsible for integrating the clean room into the existing space in accordance with BOP Technical Design Guidelines (available on request), including but not limited to: integrating ventilation, fire suppression, fire detection, electrical, lighting.

SECTION B

SUPPLIES OR SERVICES AND PRICES/COSTS

All local, state and federal codes are to be complied with. Construction shall meet BOP Technical Design Guidelines, ADA {American Disabilities Act) and NFPA (National Fire Protection Association) requirements.

Preliminary drawing is attached.

WORK HOURS / SITE CONDITIONS

The Contractor shall be responsible for all labor costs, and any overtime will be paid for by the contractor . Normal work hours are 7:00 a .m. to 3:30 p.m., Monday through Friday, excluding Federal Holidays.

Accommodations may be made, with a three day advance written request to the COR, for performance of work on weekends without additional cost to the Government.

The Contractor shall perform all work in accordance with all applicable Federal, State, and Local building construction and health codes. All work shall conform to applicable BOP Technical Design Guidelines, OSHA (Occupational Safety and Health Administration), ANSI {American National standards Institute), ASTM (American Society for Testing and

Materials) standards / regulations, and latest versions of IBC (International Building Code).

All construction material / tools shall be stored in a designated area mutually agreed upon between the Contracting

Officer’s Representative and the contractor. The storage area will be a secure lockable gang box or similar, size to be determined by the contractor and the Contracting Officer’s Representative. The gate/door to the storage box will be secured by a chain and or double locked with a contractor lock and BOP lock. All materials / tools stored within the storage box/container will be neat and stored in a safe manner. Materials cannot be stored at a height that would create a fall hazard. All tools will be inventoried prior to entering the institution. At the start of each work day all tools will be inventoried out on a daily tool inventory sheet and at the end of the work day all tools will be inventoried back in to ensure accurate accountability of all tools at the end of each work day.

Removal and disposal of all related construction materials must meet all applicable Federal, State, and Local regulations.

The contractor shall be responsible for the submission of all construction waste manifests if waste is deposited in landfills.

Additionally, the Contractor shall strictly adhere to all UNICOR security procedures at all times.

QUALITY ASSURANCE

The Contractor shall only use new materials and apparatus of specified design and manufacture, and furnishes all materials with the latest UL (Underwriters Laboratories) standards and other applicable codes/standards. Energy efficient design and equipment shall be utilized in order to comply with Executive Order 13514, dated October 5, 2009, and with

Executive Order 13423, dated January 26, 2007. The Contractor shall use Energy Star or FEMP (Federal Energy

Management Program) designated equipment where available. The Contractor shall comply with recycled content per section 6002 of the Resource Conservation and Recovery Act {RCRA) for new equipment. The Contractor shall use environmentally preferable products. The Contractor shall avoid the use of ozone depleting compounds.

CLEAN-UP

The Contractor is responsible for the removal and disposal of all associated construction debris. The Contractor shall comply with Executive Order 13423 and recycle or salvage at least 50% of the non hazardous, construction demolition materials where markets or onsite recycling opportunities exist. The Contractor shall be responsible for the delivery and disposal of dumpsters as needed. Clean-up shall be performed as required to prevent accidents to personnel, protect all work in place, and to effect completion of the project in a timely and orderly manner. Frequent clean-up and removal of all garbage, rubbish, scrap materials, etc. shall be performed to ensure a neat, orderly and safe work site is maintained.

Final cleanup shall be performed immediately prior to the Contractor’s request for final inspection and payment.

SAFETY

During the execution of all work performed under this contract, the Contractor shall be required to conform to all safety and health regulations as set forth by OSHA. The Contractor shall be required to adhere to all EPA (Environmental

Protection Agency) requirements in reference to recovery and or disposal of all environmentally hazardous materials and/or chemicals. The contractors superintendent must be have 30 Hour OSHA Training for Construction. All mechanics and general laborers must have 10 Hour OSHA Training for Construction.

LOCATION

Beaumont FCI Medium, 5980 Knauth Road, Beaumont, TX 77705

REQUIREMENTS

12,000 square feet of Class 100,000, Clean Room space (see Table 1) built into existing factory building (see blueprint below)

Clean room plans and drawings shall be reviewed, stamped and signed by a Certified Fire Engineer.

Clean room plans and drawings shall be submitted to the BOP South Central regional office via Beaumont

Facilities for approval prior to construction.

Walls and ceilings shall be of sturdy construction utilizing metal studding/ framework.

All doors, windows and openings shall be metal framed.

Doors shall be 36”x78” and hollow metal construction.

Two windows shall be placed at even intervals on each newly constructed wall and shall be at least 31” x 60” with the bottom of the glazing 39” above finished floor.

For safety and security, ALL glazing provided on this project shall, if broken, exhibit the characteristics of safety glass, i.e., to prevent bodily injury or creation of weapons (shards).

Finished product opening shall be 36” x 39” located at 2d on drawing above a removable 21” x 39” wall panel.

Raw material opening shall be 57” x 77.5” located at 3 on drawing 21” above finished floor.

Control Access room shall be adjacent to the clean room located at 2c on drawing, 16’ x 16’ and contain 4 hand washing stations and associated plumbing as well as an air curtain on the door.

Changing room shall be adjacent to the Control Access room located at 2c on drawing, 16’ x 16’.

All wall corners shall be covered.

Flooring finish shall be high quality epoxy paint or vinyl covering suitable for a Class 100,000 Clean Room.

Wall and ceiling finish shall be suitable for a Class 100,000 Clean Room.

All objects within the footprint of the clean room shall be removed by the contractor. Support beams shall stay in place and may be used by the contractor for electrical and compressed air drops.

All material openings shall have air curtains.

Fire sprinklers shall be connected to existing sprinkler piping as directed by a Certified Fire Engineer.

Smoke/heat detectors shall be connected to existing fire alarm system as directed by a Certified Fire Engineer.

Lighting shall be sufficient to yield 100 foot candles at all work surfaces.

Ten 110V 15A electrical drops shall be installed evenly throughout the clean room. Existing support beams may be used.

Ten compressed air drops shall be connected to the existing compressed air system and installed evenly throughout the clean room. Existing support beams may be used. Unicor will provide air compressor.

Contractor shall connect to existing HVAC system to provide heat removal of at least 110,000 BTU/hr in clean room as well as providing ventilation and filtering suitable for a Class 100,000 Clean Room.

A thermostat shall be provided in the clean room and connected to existing HVAC system to control clean room temperature.

Clean room shall have a finished ceiling height of 9’. Current ceilings are about 19’ 9” from finished floor.

Electrical Raceways are about 12’ from finished floor.

SECURITY CLEARANCE/CONTRACTOR BADGES

All contractors/sub-contractors (no exceptions) working on the grounds of FCI Beaumont will be issued and required to wear a picture ID/contractor badge provided by the FCI. For security reasons, the badge will be worn in a visible manner as directed by the Contracting Officer’s Representative.

The contractor shall be responsible to comply with Homeland Security Directive (HSPD) 12. The contractor is responsible to obtain all required documentation from their employees and subcontractors, review for accuracy, and submit to the FBOP.

In the event a contractor’s employee does not pass the security clearance, it shall be the contractor’s responsibility to submit another employee for security clearance.

All security clearances shall be submitted to the Contracting Officer’s Representative, a minimum of fourteen working days prior to the start of work. Security clearances will be in effect for the term of one year, and prior to the time of expiration it is the responsibility of the contractor/worker to notify the Contracting Officer’s

Representative to have clearance conducted and a badge issued.

All contractors and sub-contractor employees will provide a check list of all employees on site-each day to the

Contracting Officer’s Representative, verifying the number of workers on site each day and that all workers are pre-approved to be on the site.

SUBMITTALS

90% first review and 100% design drawings to include all divisions of work

Final As Built Drawings

All applicable material submittals

Material samples

Safety Plan

Quality Plan

Site Setup and Site Access Plan

Personnel List

MSDS

Description of existing facility:

-concrete floors

-adequate power for running required air handlers and lighting

-see blueprint below

Table 1

Cleanliness

Grade

Airborne particles

(Particle count / m3)

Airborne microbe

（CFU/m3) Standard

Remarks

0.5µm 5µm Airborne microbe/m3

Settling microbe/¢ YY0033-2000 Good

Manufacturing Practice for Sterile

Medical Device 100,000 3,500,000 20,000 500 10 QA & Test

Report Standard