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. In 2022, USP provided technical support to NTP in certification and validation of 22 biosafety cabinets of the national TB diagnostic laboratory network.
In 2023, the following laboratories, which have biosafety cabinets in their facilities, were selected for re-certification of 7 biosafety cabinets in total:
№
Destination Point
Name of the laboratory
Number of BSCs, pcs.
Note
1
Bishkek city
NRL NTP MoH
3
2
Osh city
Osh Inter-Regional Laboratory
2
Laboratory Jalal-Abad Regional TB Center
1
Jalal-Abad city (100 km from Osh)
3
Karakol city
Laboratory Issuk-Kul Regional TB Center
1
Total
7
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 Annex 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 the Annex 1 were purchased and installed from 2010-2015, with the last inspection/certification in 2022.
USP is seeking a company to re-certify the biosafety cabinets at NRL and regional TB laboratories, as per Annex 1, during the period October 1 – 31, 2023.
II Scope of Work:
Objective: Re-certification (validation) of biological safety cabinets in the National Reference Laboratory in Bishkek and regional TB laboratories in Osh, Jalal-Abad and Issyk-Kul regions (oblasts) for compliance with the standard Biotechnology Technical Requirements for Microbiological Safety Cabinets, such as:
The selected company will perform the following tasks:
1) Verify the protective effectiveness of the cabinets in accordance with the applicable standard.
2) 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
3) In case the BSC does not pass the certification, there should be a written report - why and how to fix the problems.
4) 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)
October 2023
NRL Laboratory Specialist, URC Laboratory Specialist
Consultant - USP Technical Coordinator
October 2023
October 2023
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 agency OR 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:
October 1- 31, 2023
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 July 28, 2023 When submitting your application/Proposal, write “Certification Services of Biological Safety Cabinets” in the email Subject Line.
Annex 1
A list of BSBs in TB laboratories in the KR
№
Place of location
Manufacturer,
model
S/N
Technical
parameters
Year of manufacture
Quantity
Date of last service
1
NRL NTP
Thermo Safe 1,5
Thermo Scientific
s/n: 41404992.
s/n:41404993
Voltage: 230 VAC~, class: II,
frequency: 50 Hz,
European standard :
EN 12469
2013
2
2020
Thermo Safe 1,8
Thermo Scientific
s/n: 41404995
Voltage: 230 VAC~, class: II,
frequency: 50 Hz,
European standard :
EN 12469
2013
1
2020
2
Osh ТВ-center
Model: Scanlaf Mars
Manufacturer: Germany
s/n:L08110599
s/n:L05110424
Voltage: 230 VAC~, class: II,
frequency: 50 Hz,
European standard:
EN 12469
Сurrent: 6,7 A
2011
2
2017
3
Jalal-Abad TB-center
БМБ-II- «Laminar-C» - 1.2
ЛабСоюз, Russia
s\n:221.120.00.3312
Voltage: 230 VAC~, class: II,
frequency: 50 Hz,
European standard :
EN 12469
2014
1
2017
4
Issyk-Kyl TB-Center
БМБ-II- «Laminar-C» - 1.2
ЛабСоюз, Russia
s\n:221.120.00.1837
Voltage: 230 VAC~, class: II,
frequency: 50 Hz,
European standard :
EN 12469
2014
1
2017
Total:
7
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
