Certification of Biological Safety Cabinets

Job Description

Terms of Reference

for Certification (validation) of Biological Safety Cabinets (BSCs) in TB laboratories in the Kyrgyz Republic

I. Background

The USAID “Cure TB” project is a five-year initiative (2019-2024) implemented by JSI Research & Training Institute, Inc. (JSI) in partnership with the University Research Co., LLC (URC) and the U.S. Pharmacopeia (USP) and aims to provide technical support to the Kyrgyz Republic to improve diagnosis and treatment of people with drug-resistant tuberculosis (DR-TB). The Cure TB Project works closely with the National TB Control Program (NTP) under the Ministry of Health of the Kyrgyz Republic (MoH) and national partners and is implemented with the participation of four non-governmental organizations, the project sub-grantees.

The U.S. Pharmacopeial Convention (USP) is a scientific non-profit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. USP’s focus on global public health extends to lower and middle-income countries with work in over 20 countries through donor-funded programs.

USP is a partner in the “Cure TB” program led by JSI and supports the following objectives:

- Objective 1: Improve TB detection by strengthening the TB laboratory system

- Objective 2: Improve TB drug management

The network of TB laboratories in the Kyrgyz Republic (KR) consists of the National Reference Laboratory (NRL) of the National TB Program under the Ministry of Health KR (MoH) and 103 TB laboratories at city, region, and district levels across the country.

The following laboratories have biosafety cabinets in their facilities:

№, Destination Point, Name of the laboratory, Number of BSCs, pcs. Note

1, Bishkek city, NRL NTP MoH, 4

City TB Center 1

Laboratory Chuy Regional TB Center 1 (City of Tokmok).

2, Osh city, Osh Inter-Regional Laboratory, 5

Laboratory Jalal-Abad Regional TB Center, 2 (Jalal-Abad city)

FMC Suzak, 1

3, Batken, Laboratory Batken Regional TB Center, 2

4, Naryn, Laboratory Naryn Regional TB Center, 2

5, Balykchy, Laboratory Issuk-Kul Regional TB Center, 2

6, Talas, Laboratory Talas Regional TB Center, 2

Total, 22

All procedures in these laboratories must be conducted in Biological Safety Cabinets (BSCs) designed to protect laboratory personnel and the environment from aerosols generated from suspected Mycobacterium tuberculosis bacteria samples when using the BSCs. The BSCs removes pre-filtered air from the working chamber of the cabinet into the atmosphere. See Appendix 1 for a summary of the specifications of all the BSCs installed in the laboratories.

BSCs can guarantee the safety of the personnel only if they are regularly certified and routinely maintained to ensure proper functioning. The functioning of each BSC is certified according to a national or international standard and / or manufacturer’s specifications upon installation as well as after any relocation, repair, and filter replacement. In addition, the BSCs shall be certified (validated) annually by qualified personnel as per national or international standards and/or manufacturer’s specifications. The BSCs listed in Appendix 1 were purchased and installed from 2010-2015, with the last inspection/certification in 2020.

USP is seeking a company to certify the biosafety cabinets at NRL and regional TB laboratories, as per Attachment 1, during 2Q 2022.

II Scope of Work:

Objective: Certification (validation) of biological safety cabinets in the National Reference Laboratory and regional TB laboratories in Osh, Jalal-Abad, Batken, Naryn, Issyk-Kul, Chui and Talas regions (oblasts) and in the laboratory of the Bishkek City TB Center for compliance with the standard Biotechnology Technical Requirements for Microbiological Safety Cabinets, such as:

• EN 12469, Europa, and/or
• ГОСТ Р ЕН 12469-2010, Russia, and/or
• NSF/ANSI 49, USA

• selected company will perform the following task:

• Verify the protective effectiveness of the cabinets in accordance with the applicable standard.
• Issue an appropriate certificate of conformity and test report. The report should include the following sections:

· Checking the filters for leaks

· Measurement of air velocity in the working aperture and inside the cabinets

· Visualization of airflow to determine the direction of steady airflow

· Determination of air flow into and out of the box

· Ambient light test

· Vibration test

· Noise level test

• In case the BSC does not pass the certification, there should be a written report - why and how to fix the problems.
• Provide a final report describing the condition of each BSC and recommendations for elimination of detected deficiencies and further maintenance.

III Expected results and timeline:

Deliverables, Estimated timeframe, Review and approval (Specify the person who will supervise and confirm the results)

1. 4 units BSB tested and certified in NRL, Bishkek, April 2022

NRL Laboratory Specialist, URC Laboratory Specialist

Consultant - USP Technical Coordinator

2. 1-unit BSB tested and certified in Bishkek TB-center, April 2022

3. 8 units BSB tested and certified in Osh and Jalal-Abad regional laboratories, April 2022

4. 2 units BSB tested and certified in ТВ center Batken, April 2022

5. 7 units BSB tested and certified in TB centers Chuy, Issyk-Kul, Naryn and Talas, April – May, 20, 2022

6. Report on performed activities, within 2 weeks of works completion

IV Qualification requirements:

• To be accredited to BSC certification to any of the above listed standards in the Objectives section by an independent national or international agencyOR have at least one specialist in the company’s team trained and having a certificate on the above listed standards in the Objectives section of this document;
• To have at least 3 years of experience in BSC certification;
• Provide a list of qualified employees who will certify BSCs and scanned copies of the employees’ documents confirming their education, experience and qualifications to provide these services;
• To have all necessary instruments and devices, which will be used during certification (validation) of BSC in accordance with the requirements of the standards specified in the Objectives section of this document;
• Provide valid certificates of calibration of the equipment to be used for BSC certification;
• Experience in BSC certification in Central Asia is an advantage
• Have Russian-speaking specialists;
• Issue the certificate in any of the three languages: Kyrgyz, Russian or English.

V Duration:

April-June 2022

VI How to apply:

Please send your Technical & Cost Proposal/Bid (Hourly Rate in US$), CV and 3-References to ATTN: Masoud Azam, Senior Procurement Specialist, at GPH_Procurement@USP.org by the closing date of March 30, 2022 When submitting your application/Proposal, write “Certification of Biological Safety Cabinets” in the email Subject Line.

About the Organization

The U.S. Pharmacopeial Convention (USP) is a scientific non-profit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. USP’s focus on global public health extends to lower and middle-income countries with work in over 20 countries through donor-funded programs.