The Clinical PK Laboratory is equipped with state-of-the-art equipment and infrastructure designed to provide high-quality bioanalytical services that comply with ISO, GCLP and 21 CFR Part 11 standards. Our systems are specifically designed to ensure sample integrity, maintain operational continuity, and meet regulatory requirements, thereby supporting the generation of accurate and reproducible data for global clinical research. The laboratory operates within a Biosafety Level 2 environment.

Our laboratory is equipped with a diverse range of mass spectrometry and HPLC systems, along with computer systems validated software, to support high-sensitivity, regulatory-compliant bioanalysis across a broad spectrum of clinical and research applications.

• 1 x variable wavelength HPLC workstation
• 4 × Sciex API 4000 workstations
• 2 × Sciex API 5500 workstations
• 2 × Sciex API 3200 workstations
• 1 × Sciex API 3000 workstation
• 1 × Sciex high-resolution ZenoTOF 7600 -workstation

The Sample Management Facility is a secure, validated, environmentally monitored, and access-controlled unit dedicated to the safe storage and management of clinical samples in accordance with all international standards.

Our current cold storage capacity includes:

• 11 × -80°C ultra-low temperature freezers
• 3 × -20°C freezers
• 1 × 4°C refrigerator

All freezers are fully temperature-mapped to ensure compliance with regulated bioanalytical standards. The facility operates on an emergency power supply supported by a generator, and four −80°C freezers are connected to an inverter and battery backup system that provides approximately eight hours of additional runtime during power outages. Continuous temperature surveillance is maintained through a validated IMONNIT monitoring system, coupled with an automated dial-out alarm system and monitored 24/7 to ensure the integrity and security of all stored samples.

We maintain a secure, access-controlled archive facility for the long-term storage of hardcopy documentation generated during all bioanalytical activities. The facility is environmentally monitored to ensure stable temperature and humidity conditions, and it is equipped with an automated gas fire suppression system to safeguard critical records. All access to the archive is strictly controlled and logged through a tracking system to ensure full traceability and data integrity.

The laboratory operates a secure, 21 CFR Part 11–validated computer network that is fully independent of the UCT institutional network. The system comprises two servers and 11 workstations, all of which are protected by a dedicated firewall and comprehensive monitoring software on all critical components.

All analytical data are written directly to the secure server (network acquisition), ensuring full traceability and integrity. Data is encrypted both in transit and at rest, with automated daily backups stored in an off-site, cloud-based location. System continuity is maintained through a validated backup server and off-site storage of validated PC images, enabling rapid disaster recovery.

The server room is environmentally monitored to ensure controlled temperature and humidity conditions and is equipped with a fire suppression system to protect hardware and data infrastructure. Access to the server room is strictly controlled and logged to ensure traceability. All critical network components are connected to an uninterruptible power supply (UPS), providing up to 8 hours of runtime during power outages to maintain data security and operational continuity.