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11 February 2021 Photo UFS photo archive
The National Control Laboratory for Biological Products (NCL) Building.
There can be no compromise when it comes to the quality of medicines made available to the public.

The UFS-based National Control Laboratory for Biological Products (NCL) is a full member of the international WHO-National Control Laboratory Network for Biologicals and one of 12 laboratories worldwide contracted to perform vaccine testing for the World Health Organisation (WHO). The NCL is also the only vaccine-testing laboratory in the country that performs the final quality-control testing of all human vaccine batches marketed in South Africa on behalf of the South African Health Products Regulatory Authority (SAHPRA).

In its role as a vaccine-testing laboratory for the WHO, the NCL helps to ensure that the vaccines purchased through the WHO prequalification programme for international distribution to resource-limited countries, meet the high standards of quality, safety, and efficiency. 

International testing standards

The laboratory received the status of a pharmaceutical testing laboratory after the South African Accreditation System (SANAS) endorsed its quality-management systems as of a high standard according to the International Standards Organisation’s requirements.

With its international testing standards, the NCL must ensure that all its operations – from the way documents are compiled and stored, to the maintenance of equipment and infrastructure, as well as staff competency – are performed according to international guidelines.

The laboratory has all the quality systems in place to ensure high-quality test results. The certificate of Good Manufacturing Compliance received in 2019 indicates that laboratory testing is on the expected level for any pharmaceutical testing laboratory and manufacturer. This certification is very strict and means that the NCL complies with exceptionally strict standards for pharmaceutical labs anywhere in the world. The certification offers the South African Health Products Regulatory Authority, the WHO, and other national control laboratories around the world the confidence that the test results from the NCL can be trusted.

Licensed as pharmaceutical manufacturer

The laboratory is also licensed as a pharmaceutical manufacturer. Although the lab does not manufacture, it needs to comply with manufacturing standards. It is rare for a pharmaceutical testing laboratory (such as the NCL) outside of a manufacturing context to qualify for both certifications.

News Archive

New world-class Chemistry facilities at UFS
2011-11-22

 

A world-class research centre was introduced on Friday 18 November 2011 when the new Chemistry building on the Bloemfontein Campus of the University of the Free State (UFS) was officially opened.
The upgrading of the building, which has taken place over a period of five years, is the UFS’s largest single financial investment in a long time. The building itself has been renovated at a cost of R60 million and, together with the new equipment acquired, the total investment exceeds R110 million. The university has provided the major part of this, with valuable contributions from Sasol and the South African Research Foundation (NRF), which each contributed more than R20 million for different facets and projects.
The senior management of Sasol, NECSA (The South African Nuclear Energy Corporation), PETLabs Pharmaceuticals, and visitors from Sweden attended the opening.

Prof. Andreas Roodt, Head of the Department of Chemistry, states the department’s specialist research areas includes X-ray crystallography, electrochemistry, synthesis of new molecules, the development of new methods to determine rare elements, water purification, as well as the measurement of energy and temperatures responsible for phase changes in molecules, the development of agents to detect cancer and other defects in the body, and many more.

“We have top expertise in various fields, with some of the best equipment and currently competing with the best laboratories in the world. We have collaborative agreements with more than twenty national and international chemistry research groups of note.

“Currently we are providing inputs about technical aspects of the acid mine water in Johannesburg and vicinity, as well as the fracking in the Karoo in order to release shale gas.”

New equipment installed during the upgrading action comprises:

  • X-ray diffractometers (R5 million) for crystal research. Crystals with unknown compounds are researched on an X-ray diffractometer, which determines the distances in angstroms (1 angstrom is a ten-billionth of a metre) and corners between atoms, as well as the arrangement of the atoms in the crystal, and the precise composition of the molecules in the crystal.
  • Differential scanning calorimeter (DSC) for thermographic analyses (R4 million). Heat transfer and the accompanying changes, as in volcanoes, and catalytic reactions for new motor petrol are researched. Temperature changes, coupled with the phase switchover of fluid crystals (liquid crystals -watches, TV screens) of solid matter to fluids, are measured.
  • Nuclear-magnetic resonance (NMR: Bruker 600 MHz; R12 million, one of the most advanced systems in Africa). A NMR apparatus is closely linked with the apparatus for magnetic resonance imaging, which is commonly used in hospitals. NMR is also used to determine the structure of unknown compounds, as well as the purity of the sample. Important structural characteristics of molecules can also be identified, which is extremely important if this molecule is to be used as medication, as well as to predict any possible side effects of it.
  • High-performance Computing Centre (HPC, R5 million). The UFS’ HPC consists of approximately 900 computer cores (equal to 900 ordinary personal computers) encapsulated in one compact system handling calculations at a billion-datapoint level It is used to calculate the geometry and spatial arrangements, energy and characteristics of molecules. The bigger the molecule that is worked with, the more powerful the computers must be doing the calculations. Computing chemistry is particularly useful to calculate molecular characteristics in the absence of X-ray crystallographic or other structural information. Some reactions are so quick that the intermediary products cannot be characterised and computing chemistry is of invaluable value in that case.
  • Catalytic and high-pressure equipment (R6 million; some of the most advanced equipment in the world). The pressures reached (in comparison with those in car tyres) are in gases (100 times bigger) and in fluids (1 500 times) in order to study very special reactions. The research is undertaken, some of which are in collaboration with Sasol, to develop new petrol and petrol additives and add value to local chemicals.
  • Reaction speed equipment (Kinetics: R5 million; some of the most advanced equipment in the world). The tempo and reactions can be studied in the ultraviolet, visible and infrared area at millisecond level; if combined with the NMR, up to a microsecond level (one millionth of a second.

Typical reactions are, for example, the human respiratory system, the absorption of agents in the brain, decomposition of nanomaterials and protein, acid and basis polymerisation reactions (shaping of water-bottle plastic) and many more.

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