Objectives

The primary objective of this tender is to acquire a Real-Time Cell Analysis (RTCA) system for Onderstepoort Biological Products (OBP). The system aims to enable label-free, impedance-based monitoring of cell cultures in real time to support vaccine research, process optimization, and virological investigations. It will facilitate continuous monitoring of cell growth, viability, and cellular responses, thereby enhancing research productivity, improving process development for vaccines, and strengthening analytical capabilities within the organization.

Scope

The scope of the tender includes the procurement of an RTCA system capable of:

• Performing label-free, real-time impedance-based monitoring of cell cultures in standard microplate formats (preferably 96-well plates).
• Operating within a standard CO₂ incubator with specified dimensions and environmental conditions.
• Providing associated hardware, software licenses, training, installation, validation, warranty, and local maintenance support.
• Supporting applications such as cell proliferation, characterization, cytotoxicity assays, immune-cell killing assays, and virus-induced cytopathic effects.
• Ensuring compatibility with South African electrical standards and providing UPS support for up to 4 hours during power outages.

Technical Requirements

The technical specifications for the RTCA system include:

• Equipment must accommodate a minimum of 4 x 96-well plates.
• Dimensions: External (660x660x906mm), Internal (505x535x633mm).
• Operating temperature: 20 to 40°C; Humidity: up to 90% RH.
• Power supply: 240V, 50Hz with UPS support (1.5–2 KVA).
• Warranty: 36 months; Maintenance: 2 years with local support.
• Software features: Live and endpoint plots including resistance, capacitance, impedance magnitude, barrier index, % cytolysis, area under the curve, kill time50, EC50/IC50, with capabilities for real-time and endpoint analysis, curve fitting, data export, and system diagnostics.
• Compliance with FDA 21 CFR Part 11 standards.
• Delivery, installation, and commissioning to be handled by the supplier, with development and execution of IQ and OQ protocols.

Skills Requirements

The supplier must demonstrate:

• Relevant experience and capabilities in supplying RTCA systems.
• Ability to handle delivery, installation, and commissioning at the final site.
• Development and execution of installation and operational qualification protocols.
• Provision of comprehensive user manuals, technical documentation, and maintenance guides in English.
• Training for users, including onsite training and technical support for at least 3 months post-installation.
• Local service support and maintenance capabilities.