SOW Cleanroom.pdf

NATIONAL INSTITUTES OF HEALTH Office of Research Facilities

Division of Facilities Operation and Maintenance

Bldg. 13, Rm. B1E65G, 9000 Rockville Pike, Bethesda, MD 20892

STATEMENT OF WORK

Perform cleanroom certification

Work Order # C108399

PROJECT DESCRIPTION

The contractor shall provide cleanroom certification of the National Institutes of Health, NIH, Interim - Intravenous Admixture Unit, 1-IVAU, 2J Cell Processing, and 1B42 Viral Vector Lab. Certification will include ISO certification of the Immunotherapy Preparation Room and initial certification of a new biologic safety cabinet (BSC3). The contractor shall furnish all labor, materials, equipment, and supervision necessary to accomplish the work. The contractor shall ensure that all personnel are qualified, trained, and experienced in the types of equipment and cleanrooms, requirements, and processes as described herein. The contractor shall follow all facility requirements, e.g. facility entry standard operating procedures. Work may be after-hours and/or multiple mobilizations.

The contractor shall coordinate a kick-off meeting and provide sample deliverables as indicated in the Deliverables and Schedule section.

The contractor shall coordinate and provide clean room testing and certification report to include the fo11owing and as detailed in the Deliverables and Schedule section. The testing shall be performed in an At- Rest-Facility condition or Operating-Facility condition as coordinated with the APF End User. The contractor shall perform all testing and provide test result documentation in accordance with ISO Standards 14644- 1:2015, 14644-2:2015, and 14644-3:2005. Testing for the biologic safety cabinet will also include ce1tification requirements as set forth in current version of NSF Chapter 49. If any testing is found non-compliant, the contractor shall notify the APF End User and the Project Officer immediately at conclusion of testing. ISO Classified Zones include the ISO Classified Room (see attached diagram) and ISO Classified and Biosafety Cabinet (BSC) (see attached table).

1. Particulate count testing, and documentation of each ISO Classified Zone (Rooms and BSCs tested to ISO 14644-1:2015)

2. Air changes per hour (ACH) testing and documentation of each ISO Classified Zone (Acceptance

Criteria provided by NIH)

3. Air velocity testing and documentation of each ISO Classified LFW and BSC

4. HEPA filter integrity testing and documentation of each ISO Classified LFW and BAC (Test to IEST-RP-CC006.3)

The contractor shal1 provide a certification report as detailed in the Deliverables and Schedule section.

The contractor shall provide all support qualification and process documentation as detailed in the Deliverables and Schedule section.

Deliverables and Schedule

5. The contractor shall coordinate a kick-off meeting to occur within 2 days of award. At the time of the kick-off meeting, the contractor shall provide sample test result documentation and certifications to be included in Cleanroom Certification Report as detailed below.

6. The contractor shall schedule a meeting with the APF End User and perform all testing by the dates coordinated with the APF End User. The contractor shall complete and submit work planning documentation as required by the APF End User.

4. The contractor shall submit the Cleanroom Certification Report and report of testing (if applicable) within 3 days of completion of testing. If airflow visualization studies are performed a report shall be included.

The Cleanroom Certification Report shall meet ISO Standards 14644-1:2015, 14644-2:2015, and 14644-3:2005 for test result reporting requirements and also include the following:

A) Include Cleanroom Certification Report cover sheet, including the following:

i) Facility Name

ii) Date(s) of Test Perfom1ance

iii) Company Performing Test

iv) Name of Technician

v) Name of Reviewer

B) Include individual test result documentation for each ISO Classified Zone, including the following:

i) Room Number

ii) Make, Model, Serial Number as applicable

iii) ISO Classification Level

iv) State during Testing of Facility: At-Rest-Facility condition or Operating-Facility condition

v) Date of Test Performance

vi) Test Performed

vii) Test Results

viii) Diagram of Zone with Test Locations and Results, including room dimensions

ix) Reference Instrument Used

x) Requirements by ISO Classification of Space

xi) Name, Signature, Date of Technician

xii) Name, Signature, Date of Reviewer

C) Include NIST traceable standards for all reference instruments. Provide training certificates for staff.

D) Include individual cleanroom certification for each ISO Classified Zone, including the following: ·

i) Room Number

ii) Make, Model, Serial Number as applicable

iii) Statement indicating compliance of zone to requirements, including the following:

( l) ISO Classification Level

(2) ISO Standards for Requirements

(3) Tests Performed

(4) ISO Standards to which tests were performed

(5) Date(s) of Test Performance

iv) Name, Signature, Date of Reviewer

5) Any failed HEPA filters or failed acceptance criteria for ACH, particulate, dP customer will be notified right away. The contractor shall provide field documents upon completion. The contractor shall provide qualification documentation of technician performing testing and of reviewer certifying test results and certification report within 5 business days of completion of testing along with Cleanroom Certification Report.

Working Hours/Duration:

This project task shall be performed during SPECIFIC AVAILABLE HOURS provided by end user staff with the specific day/schedule(afterhours) to be coordinated with DFOM staff. Multiple deployments may be required to complete the work.

The sched u le must be submitted and roved by the Project Officer in advance of work to be performed.

Notify Project Contracts Team, prior to beginning work for verification of location, scheduling, and posting of required (WORK AREA) signs. All SOS and PPE shall be work at all times as required. A system shutdown requires a minimum of 14 days advance notice which must be coordinated and approved by Facility Manager before work can begin. Notify the Project Officer at the conclusion of the project for final inspection. Clean all debris from site and dispose of properly.

Facility

Location

CNC

(sf)

IS0-8

1S0-7

Unit

Total

Hoods

(BSC/LFW)

Terminal HEPA

Filters

DTM-

2J

Bldg. 10- 2N307 811 363 2,659 3,833 10 39

1-IVAU

Bldg. 10 - 1(166 1,589 479 1,182 3,250 6 39

Viral Vector Facility

Bldg. 10 -