Draft SOW Pharmacy Testing-Certification of Sterile Compounding Areas final.doc

Pharmacy Testing/Certification of Sterile Compounding Areas Overton Brooks VA Medical Center

510 E. Stoner Avenue

Shreveport, LA 71101-4295

Statement of Work (SOW) Contractor shall furnish all labor, equipment, tools, materials and travel necessary to test, inspect and certify Government Owned equipment and pharmacy clean rooms to ensure proper operation of the pharmacy primary engineering controls (PECs) and secondary engineering controls (SECs) to include Compounding Aseptic Containment Isolator (CACI), Compounding Aseptic Isolators (CAI), Laminar Air Flow Workbench (LAFW), Biological Safety Cabinet (BSC), Containment Segregated Compounding Area (C-SCA), and pharmacy cleanroom suite per USP 797/800, CETA-CAG, and manufacturer’s requirements. Contractor shall provide Controlled Environment Testing Association (CETA) certified technician to perform all testing, inspections, and certifications. This SOW will cover base year + 4 option years.

CERTIFICATION OF CLASSIFIED AREAS is to be performed under dynamic conditions.

· Certification to include:

· Airflow Testing

· HEPA filter integrity testing (PECs) and (SECs)

· Dynamic airflow pattern smoke testing

· Total particle count testing in all classified areas (including total particle count in each pass through of the SECs)

· Site installation assessment testing

· Viable air sampling

· Viable surface sampling CERTIFICATION OF CLASSIFIED AREAS is required to be completed every six months. The LAFW and BSC must be certified on a different schedule than the CAI and CACI (ideally 3 months apart) due to operational requirements. The required certifications are:

· LAFW, BSC, and cleanroom suite (Hazardous Buffer, Non-Hazardous Buffer, and Anteroom) certification Semi-annually.

· CAI, CACI, and C-SCA certification Semi-annually.

· DCA Smoke Study on LAFW, BSC, CAI and CAIC with certification semi-annually.

· HD Surface Wipe Samples must be done on the Hazardous Buffer room cart, bottom of chemo pass through, the floor of the anteroom just outside the door of the Hazardous Buffer Room, below the BSC, on the cart in the C-SCA next to the CACI, and on the floor below the CACI pass through door. These samples must be taken during the certification of the PECs semi-annually.

CALIBRATION OF MONITORS AND AIR DEVICES

All temperature, pressures, humidity monitors, and air control devices must be tested and calibrated within each zone, space, and at the equipment. The Contractor shall provide qualified technicians employed directly by the contractor (i.e. Control System Engineer, Testing and Balance Agent, Commissioning Agent) as needed to perform the work.

List of devices and sensors

A. Cleanroom suites (1E95k, 1E95H, 1E95L)

1. Temperature/humidity Monitor (3 monitors)

a. NS-BHB-7001-0 (Discontinued)

1) Replacement Part #NSB8BHN240-0

2. Pressure Monitor (3 monitors)

a. LB-RPM1611-0

3. Phoenix Control valves (5 devices)

a. Calibrate and certify each Phoenix Control Valves

b. Test each Air Valve with calibrated velometer at each grill in each room

c. Verify correct integrated reading on the JCI building management computer

B. 1E300 (C-SCA)

1. Pressure Monitor (1 monitor)

a. LB-RPM1611-0

ENVIRONMENTAL SAMPLING

· Performed under dynamic conditions.

· Performed in locations identified in the facility sampling plan.

· Air Sampling - Impaction volumetric air sampling under dynamic conditions with a sample size of at least 1000 liters in each location. Two samples in the direct compounding area (DCA) of the LAFW and the BSC. One sample on the cart in each of the buffer rooms (2); one sample in each of the DCAs of the CAI and CACI; one sample in each of the antechambers of the CAI and CACI; one sample in each of the pass-throughs located in each SEC; one sample in the ante room on the clean side of the line of demarcation and six samples to be determined on work patterns. Total of 19 samples for bacterial and/or fungal contaminates.

· Surface Sampling – Sampling to take place at the end of the compounding activity prior to cleaning. Two samples in the DCAs of the LAFW and the BSC. One sample on the cart in each of the buffer rooms (2); one sample in each of the DCAs of the CAI and CACI; one sample in each of the antechambers of the CAI and CACI; one sample in each of the pass-throughs located in each SEC; one sample in the ante room on the clean side of the line of demarcation and six samples to be determined on work patterns. Total of 19 samples for bacterial and/or fungal contaminates.

· In-house surface sampling(monthly) – contractor to supply 40 media plates each month (as requested) and incubation, reading and results from surface sampling.

· Media plates - must be TSA supplemented with neutralizing additives (e.g., lecithin and polysorbate 80). If this media is not available, contractor must notify site to request approval for a different media that would meet USP <797> requirements.

· Media Incubation- media plates must be incubated at 30-35°C for no less than 48 hours, then 20-25°C for no less than 5 additional days.

· Microbial Identification – contractor must provide microbial ID to the genus level of all CFUs identified. ID of microbes must be provided in a separate report labeled for Quality Assurance/Internal Use Only.

Frequency of testing

Environmental Sampling is to be performed quarterly. If a failure results, then retesting must be scheduled as soon as corrective actions have been completed. Vendor must be able to return to the site for retesting within 72 hours. Eight return visits for retesting must be allotted for each year in the contract.

The following information must be provided to the pharmacy for all equipment used in the certification and sampling process:

· Manufacturer

· Model

· Serial Number

· Equipment calibration date

· Calibration Due Date

· Acceptance criteria for each test

· Pass/Fail statement for each test and for the unit overall

· Pass/Fail refer to any appropriate industry standards.

· Type of engineering control

· Name of certifier (signed)

· Venting criteria – to room, to roof, exhaust fan, type of damper

· Type of agar use in sampling

· Lot and expiration date of all media used in sampling

· Certificate of analysis of media used in sampling to verify that the devices meet the expected growth promotion, pH and sterilization requirements.

SMOKE STUDY –

Smoke study to be performed and videoed bi-annually with certification of each PEC. Smoke study video must trace the airflow from the entrance plane (the HEPA filter diffuser screen) across the DCA to the exit plane. The entrance plane in a vertical-flow unidirectional PEC is the HEPA filter diffuser screen above the work surface which will traverse the entire entrance plane from front to back wall and side wall to side wall. The exit plane in a vertical flow PEC is the work surface. For example, the BSC vertical air must be traced from the diffuser screen, across the critical sites in the DCA, to and into the air grilles at the front and rear of the work surface. In a horizontal flow PEC, the entrance plane will be the entire diffuser screen against the back wall, from top to bottom and side wall to side wall. The smoke videos must also capture airflow around any equipment used within the PEC, such as Omnicell IVX. The smoke video must also capture simulated compounding in the DCA that closely resembles normal compounding. Each study video must be of adequate length for viewer to see the directional air flow completely. The smoke videos must be provided to the facility in a file format that will allow local storage and retention.

HAZARDOUS DRUG SURFACE WIPE SAMPLING –

Hazardous drug surface sampling to be performed semi-annually with certification of the BSC and pharmacy cleanroom suite. Sampling to be performed on the Hazardous Buffer room cart, bottom of chemo pass through, the floor of the anteroom just outside the door of the Hazardous Buffer Room, on the floor below the BSC, on the cart in the C-SCA next to the CACI, and on the floor below the CACI pass through door. These samples must be taken during the certification of the PECs semi-annually. These location may be changed if other areas of risk are identified.

Contractor shall provide written certification reports upon completion of testing to include the CETA certification certificate of the technician performing the test, inspection and certification. Written report will be provided within 15 days of completion of job. Written report must contain:

· Test results, media lots utilized for samples, comments indicating:

· Dynamic conditions were used

· Certificates of Analysis of media used

· Room number

· sketches depicting testing locations which must match facility sampling plan unless a decision was made by the facility subject matter expert(s) to change location(s).

· All calculations

· Number of staff present in each PEC and SEC during total particle count test and dynamic air flow smoke pattern test.

· A list of recommendations and discrepancies must also be provide with the report.

Written advisement will include any issues which will impact testing/certification. Contractor will also advise Shreveport’s Program Manager and COR of recommendations to resolve any issues related to the regulatory changes. Contractor will schedule any work required to meet certifications of equipment with the COR upon approval of funds, such as replacement of parts, installation of new HEPA filters, or any other deficiencies identified.

DELIVERABLES

After all work is completed, the Contractor is to submit in writing, a complete report of services performed for each item of equipment and must include the information listed above within 15 days of completion. The report shall have guidance on interpreting results, possible contamination pathways and proper corrective actions to remediate contamination. The contractor shall supply and place a certification sticker on every PEC that passes certification specifications. This sticker must include the expiration month and year of the certification. Lastly, a current copy of the CETA certificate of the technician that performed the test must be included in the report.

SPECIAL PROPOSAL CONSIDERATIONS BY THE CONTRACTOR:

None

SAFETY CONSIDERATIONS:

Contractor’s workmen shall provide and utilize any items required to ensure safety requirements are in accordance with OSHA regulations during all phases of the work.

NOTE:

Most work is to be performed during the duty hours of 7:30 AM and 4:30 PM, Monday through Friday, exclusive of Federal holidays. However, if any work is required to be performed outside of normal working hours approval of the COR will be required.

Contractor will not be allowed to use Government tools, materials, and/or labor for this project.

TIMELINE: Base plus 4 contract

Base:

October 1, 2025 to September 30, 2026 Option year 1 October 1, 2026 to September 30, 2027 Option year 2 October 1, 2027 to September 30, 2028 Option year 3 October 1, 2028 to September 30, 2029 Option year 4 October 1, 2029 to September 30, 2030