SOW.pdf

A. INTRODUCTION:

To follow USP Chapter 797/800 and CETA guidelines, Whiteriver Pharmacy’s Cleanroom, Laminar Flow Hood and Barrier Isolator require biannual certification.

B. BACKGROUND:

USP Chapter 797/800 provides guidance to be followed for the preparation of compounded sterile preparations (CSP). Whiteriver currently practices under CSP Category 2 which requires more stringent controls and testing but allows for longer beyond use date (BUD). These controls/testing in accordance to USP 797/800 is required every 6 months.

C. SCOPE OF REQUIREMENT:

Pharmacy Cleanroom Each Cleanroom shall be tested in accordance with ISO Standard 14644, IES-006 and Industrial Ventilation Guidelines. Below are the individual tests to be provided.

1. Each Cleanrooms shall be particle counted to meet its’ air cleanliness classification level at ISO Class 7 at ≥0.5μm particles. Per USP 797, the room shall be in the “Dynamic” state or a simulated “Dynamic” state during the testing.

2. The total supply airflow shall be measured at each air register or Terminal HEPA filter. Based on the total airflow of each room, the air exchange rates will be calculated.

3. A total of seven (7) Terminal HEPA filters shall be integrity tested for leakage.

4. The differential pressure will be measured at each doorway to verify the Cleanroom is properly pressurized in relation to its’ adjacent area.

5. Viable air testing shall be performed in each Cleanroom. A total of ≥1 sample location shall be tested in the room for both bacteria and fungi. The incubation and processing of the agar samples shall be forwarded to and processed by an independent accredited laboratory.

6. Viable surface testing shall be performed in each Cleanroom. A total of ≥1 sample location shall be tested in the room for both bacteria and fungi. The incubation and processing of the agar samples shall be forwarded to and processed by an independent accredited laboratory.

Laminar Flow Hood (Pharmacy) The laminar flow hood shall be tested in accordance with IES-002, ISO 14644 and manufacturer’s specifications. Below are the individual tests to be provided.

1. The hood shall be particle counted to meet ISO Class 5 specifications at ≥0.5μm particles. Per USP 797, the hood shall be in the “dynamic” state or a simulated “dynamic” state during the testing.

2. Primary testing to be performed on each hood includes an air velocity profile, calculated average outflow velocity and integrity testing of the HEPA filter(s).

3. An airflow visualization profile shall be provided over the work area.

4. Viable air testing shall be performed in the work area of each hood. A total of

≥1 sample location shall be tested in the unit for both bacteria and fungi. The incubation and processing of the agar samples shall be forwarded to an independent accredited laboratory for processing.

5. Viable surface testing shall be performed in each Cleanroom. A total of ≥1 sample location shall be tested in the room for both bacteria and fungi. The incubation and processing of the agar samples shall be forwarded to and processed by an independent accredited laboratory.

Barrier Isolator (Pharmacy) The Barrier Isolator shall be tested in accordance with ISO 14644, CETA and manufacturer’s specifications. Below are the individual tests to be provided.

1. Each Barrier Isolator shall be particle counted to meet ISO Class 5 specifications at ≥0.5μm particles. Per USP 797, the hood shall be in the “dynamic” state or a simulated “dynamic” state during the testing. The particle counting shall be performed in both the Main and Pass-Through Chambers.

2. Primary testing to be performed on each Isolator includes an air velocity profile, airflow smoke pattern testing and integrity testing of the HEPA filter(s).

3. Pressure testing shall be performed for each chamber with the doors being opened and closed as well as the gloves being inserted and retracted.

4. Viable air sampling shall be performed in both the Main and Pass through Chambers of each Isolator. A total of ≥1 sample location shall be tested in each Chamber for both bacteria and fungi. The incubation and processing of the agar samples shall be forwarded to an independent accredited laboratory for processing.

5. Viable surface sampling shall be performed in both the Main and Pass through Chambers of each Isolator. A total of ≥1 sample location shall be tested in each Chamber for both bacteria and fungi. The incubation and processing of the agar samples shall be forwarded to an independent accredited laboratory for processing.

Biological Safety Cabinet (Laboratory) The Class II biological safety cabinet in the Laboratory shall be tested in accordance with NSF Standard 49 and manufacturer’s specifications. Below are the individual tests to be provided for the hood.

Primary testing to be performed on the BSC includes an air velocity profile, calculated average inflow velocity, airflow smoke pattern testing and integrity testing of the HEPA filter(s).

Listed on the following page are the associated costs to complete this service every 6 months. All prices include labor, materials and travel costs to complete the testing.

The cost for the viable sampling includes all lab fees. Per USP 797, any detected CFU(s) from the sampling shall be identified to the genus level by the lab.

Surface Sampling Agar plates are needed for monthly testing as well as in conjunction with media-filled testing to assess aseptic manipulation competency.

D. ESTIMATED ANNUAL QUANTITIES:

Estimated Annual Test Quantities:

Item Item Description Unit Cost

QTY Total

1 Clean Suite Testing (3 rooms)

- Particle Counts, Airflows, Pressure, Temp, RH

$ 2 $

2 In-Place Leak Testing of Terminal HEPA Filter $ 14 $

3 Certification of Laminar Flow Hood $ 2 $

4 Certification of Pharmacy Barrier Isolator $ 2 $

5 Certification of Biological Safety Hood (Lab) $ 2 $

6 Viable Air Test (Baceteria/Fungi) – 14 samples

- Cleanroom (6)

- Laminar Flow Hood (2)

- Control Sample (2)

- Includes Lab Fees/Genus ID

$ 28 $

7 Viable Surface Test (Bacteria/Fungi) – 14 samples

- Cleanroom (6)

- Laminar Flow Hood (2)

- Barrier Isolator (4)

- Control Sample (2)

- Includes Lab Fees/Genus ID

$ 28 $

8 Viable Sampling Retest if needed

- Ante Room Isolator Viable Samplings

- Includes Controls

- Includes Lab Fees/Genus ID

- Includes Travel Charges

$ 2 $

9 Agar Plates for Monthly Viable Surface Sampling for Bacteria / Fungi and for Gloved Fingertip Testing post garbing and post media fill required by staff delivered every other month

- 3 Cleanrooms (6 Total Samples)

- 1 Pharmacy Isolator (4 Total Samples)

- 1 Laminar Flow Hood (2 Total Samples)

- Controls (2)

$ 120 $

10 Shipping $ 6 $

11 Agar Plates for Monthly Viable Surface Sampling for Bacteria/Fungi` Gloved fingertip Testing post garbing and post media fill required by staff

$ 60 $

E. SHIPMENT:

Contractor shall identify the IHS purchase order number on all packing slips for tracking and payments purposes. Failure to list the IHS purchase order number may cause payment delays.

F. PERIOD OF PERFORMANCE:

The Contractor shall provide services 2x per year with follow up as needed. The Contractor will also provide supplies for purchase by Whiteriver Hospital.

G. DESIGNATED CONTRACTING OFFICERS REPRESENTATIVE (COR):

Brian Campbell, Telephone No. (928) 338-3553, email address:

brian.campbell@ihs.gov is hereby designated the COR to monitor the requirements of this order on behalf of the government.

1. The Contracting Officer shall designate the COR representing the

Government for the purpose of this contract in writing. Such designation will set forth the duties specifically delegated in regard to the performance of this contract. A copy of the designation will be provided to the contractor.

2. The major responsibility of the COR is to ensure Contractor accountability, monitor contract performance, and assist the Contractor in the resolution of program problems encountered during the performance of this contract.

3. The COR shall be responsible for:

a) Monitoring the Contractor’s technical progress, including the surveillance and assignment of performance and recommending to the contracting Officer changes in requirements;

b) Interpreting Statement of Work;

c) Performing technical evaluation as required;

d) Performing technical inspection and acceptance required by the contract;

e) Assisting the contractor in the resolution of technical problems encountered during performance.

The COR’s responsibilities will be to coordinate with the contractor the technical aspects of this service and the review of performance hereunder. The COR does not have the authority to change or alter the order amount, terms and conditions.

H. WRSU POINT OF CONTACT:

Amy Nguyen

Telephone: (928) 338-3508 Inpatient Pharmacy Email: amy.nguyen@ihs.gov

200 W Hospital Dr Whiteriver, AZ 85929

I. CONTRACTOR POINT OF CONTACT (TO BE DETERMINED):