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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

NRF grants of millions for Kovsie professors
2013-05-20

 

Prof Martin Ntwaeaborwa (left) and Prof Bennie Viljoen
20 May 2013


Two professors received research grants from the National Research Foundation (NRF). The money will be used for the purchase of equipment to add more value to their research and take the university further in specific research fields.

Prof Martin Ntwaeaborwa from the Department of Physics has received a R10 million award, following a successful application to the National Nanotechnology Equipment Programme (NNEP) of the NRF for a high-resolution field emission scanning electron microscope (SEM) with integrated cathodoluminescence (CL) and energy dispersive X-ray spectrometers (EDS).

Prof Bennie Viljoen from the Department of Microbial, Biochemical and Food Biotechnology has also been awarded R1,171 million, following a successful application to the Research Infrastructure Support Programme (RISP) for the purchase of a LECO CHN628 Series Elemental Analyser with a Sulphur add-on module.

Prof Ntwaeaborwa says the SEM-CL-EDS’ state-of-the art equipment combines three different techniques in one and it is capable of analysing a variety of materials ranging from bulk to individual nanoparticles. This combination is the first of its kind in Africa. This equipment is specifically designed for nanotechnology and can analyse particles as small as 5nm in diameter, a scale which the old tungsten SEM at the Centre of Microscopy cannot achieve.

The equipment will be used to simultaneously analyse the shapes and sizes of submicron particles, chemical composition and cathodoluminescence properties of materials. The SEM-CL-EDS is a multi-user facility and it will be used for multi- and interdisciplinary research involving physics, chemistry, materials science, life sciences and geological sciences. It will be housed at the Centre of Microscopy.
“I have no doubt that this equipment is going to give our university a great leap forward in research in the fields of electron microscopy and cathodoluminescence,” Prof Ntwaeaborwa said.

Prof Viljoen says the analyser is used to determine nitrogen, carbon/nitrogen, and carbon/hydrogen/nitrogen in organic matrices. The instrument utilises a combustion technique and provides a result within 4,5 minutes for all the elements being determined. In addition to the above, the machine also offers a sulphur add-on module which provides sulphur analysis for any element combination. The CHN 628 S module is specifically designed to determine the sulphur content in a wide variety of organic materials such as coal and fuel oils, as well as some inorganic materials such as soil, cement and limestone.

The necessity of environmental protection has stimulated the development of various methods, allowing the determination of different pollutants in the natural environment, including methods for determining inorganic nitrogen ions, carbon and sulphur. Many of the methods used so far have proven insufficiently sensitive, selective or inaccurate. The availability of the LECO analyser in a research programme on environmental pollution/ food security will facilitate accurate and rapid quantification of these elements. Ions in water, waste water, air, food products and other complex matrix samples have become a major problem and studies are showing that these pollutants are likely to cause severe declines in native plant communities and eventually food security.

“With the addition of the analyser, we will be able to identify these polluted areas, including air, water and land pollution, in an attempt to enhance food security,” Viljoen said. “Excess levels of nitrogen and phosphorous wreaking havoc on human health and food security, will be investigated.”

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