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Tender for Supplying a Pharmaceutical Stability Chamber to FXB Rwanda

FXB Rwanda

FXB Rwanda started its work in 1995 under FXB International created in 1989. In 2012, FXB Rwanda was registered as a local Non-Governmental Organization and continued to be affiliated to FXB International.

Right in 1995, the organisation started implementing the programs which were to back economically the vulnerable families specifically due to increased vulnerabilities resulting from Genocide. FXB Rwanda partnered with government of Rwanda and other stakeholders in the process of helping the community and the country to recover from these effects

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Subject: Tender for Supplying a pharmaceutical stability chamber to FXB Rwanda
Tender Reference: 010/G/FXB/2024

Introduction

FXB Rwanda is a Rwandan Local Non-Governmental Organization (NGO) committed to addressing the root causes of poverty as a means of securing children’s rights to survive, grow, and develop. FXB strives to catalyze long-lasting, positive change for low- and moderate-income families affected by poverty and HIV/AIDS by supporting improvements in social, economic, and environmental conditions.

The Rwanda National Industrial Research and Development Agency (NIRDA) in partnership with FXB Rwanda are implementing a joint project aimed at producing and commercializing herbal medicinal products in Rwanda. The success of POSE project hinges on full compliance with the regulatory standards set by the Rwanda Food and Drugs Authority (FDA) including implementing the stability testing using a modern pharmaceutical stability chamber to assure the safety of produced phytomedicines.  To support these efforts, FXB Rwanda invites interested and qualified companies or individuals to submit bid documents for supplying a Pharmaceutical Stability Chamber.

Pharmaceutical Stability Chamber specifications

The specifications of pharmaceutical stability chamber are listed in the table below:

Feature

Specifications

Safety and Environmental Protection

Testing Capabilities

 

  • Accelerated test: 40ºC ± 2ºC / 75%RH ± 5%RH
  • Intermediate: 30ºC ± 2ºC / 65%RH ± 5%RH
  • Long-term: 25ºC ± 2ºC / 60%RH ± 5%RH or 30ºC ± 2ºC / 65%RH ± 5%RH
  • Special drug test: 40ºC ± 2ºC / 20%RH ± 3%RH

Safety Assurance

Dual protection with an independent temperature limit control system, compressor overheating, overpressure, and overload protection, as well as water shortage protection.

Operating Conditions

  • Ambient temperature ranges of 5ºC to 35ºC.
  • Desired temperature range (0ºC~65ºC) and humidity range (20%~95% RH).

Technical Parameters

 Model

Pharmaceutical Stability Test Chamber

Supply Voltage

AC 220V 50Hz 0°C

Temperature range

0°C~65°C/10°C~65°C

Temperature fluctuation/uniformity

±0.5°C/±2°C

Humidity range

20~95%RH/30~95%RH

Humidity deviation

±3%RH

Inner dimensions (mm)

550*520*900

External dimensions(mm)

720*720*1675

Cargo tray (standard)

3

Temperature and Humidity Control

 Programmable touch screen controller with PID automatic adjustment.

99 cycles * 30 segments, adjustable for 1 to 9999 hours or minutes.

Compressor and Refrigerant.

High-quality industrial compressor using environmentally friendly fluorine-free refrigerant (R404a) for energy savings.

Airflow Design

Low-noise imported roller fan and unique air duct design for even temperature and humidity distribution.

Cooling and Control System

Bypass cooling capacity control technology with a dynamic, precision constant temperature and humidity control system.

Humidification Stability

Built-in quick mixing device with automatic water level adjustment and alarm function for stable humidification and reliable long-term operation.

Sensors

High temperature- and humidity-resistant imported sensor with high sensitivity and low error margin.

Data management

 Print function and USB interface for data printing, backup, and real-time temperature and humidity recording.

Safety and alarm Systems:

Independent temperature-limiting alarm system for safe operation.

Convenience

25mm test hole on the left side for experimental operation and temperature measurement.

Equipment qualification requirements

The selected supplier must perform and provide the following:

Perform all required equipment qualifications including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to confirm that the equipment meets the specified standards and is fully operational.

  • Provide user manuals for the equipment
  •  Provide compliance certificates, ensuring the equipment complies with relevant regulatory and industry standards.

Qualification details

Bid documents in a sealed envelope, should be submitted to FXB Rwanda Coordination office, located in Kamonyi District, Runda Sector, Ruyenzi cell, Rubumba Village. The deadline for submission is Friday May 2, 2025 at 4:00 P.M. The bidder shall submit the following administrative documents:

  • Price schedule/quotations for all needed materials detailing prices that include and without VAT
  • Copy of the incorporation certificate;
  • Valid Tax clearance certificate from Rwanda Revenue Authority
  • Copy of clearance certificate from Rwanda Social Security Board (RSSB)

The selected supplier will deliver the pharmaceutical stability chamber to the NIRDA/FXB-POSE project at NIRDA-HUYE Research center located in HUYE District, Ngoma Sector.

Delivery period: 3 months.

Bidder should include his/her email address and phone number for feedback. Bidders without an email address and phone number will not receive updates on their application.

Done at Ruyenzi on April 25, 2025

Emmanuel KAYITANA

Executive Director

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