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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

Machinery and equipment to the value of R6 million acquired by UFS Instrumentation Division
2015-07-02

Photo: Supplied

At an information session held on the Bloemfontein Campus, the Instrumentation Division in the Faculty of Natural and Agricultural Sciences at the University of the Free State (UFS) introduced its new Computer Numeral Control (CNC) machines to the value of R6 million.

Initially, the primary aim of the Instrumentation workshop was to design, produce, and maintain special research equipment which is unavailable on the market, mainly for academic departments. The small-scale production focused on producing support material and equipment for research work.

However, with new equipment and machinery the Division now also can deliver a service to corporate companies and external associates.
 
The CNC machines include a 5-axis Vertical Machining Centre from Haas imported from America. This is one of only four in South Africa, with two in Johannesburg and one in Cape Town.  The lathe makes it possible to produce sophisticated parts, which were previously cumbersome and difficult to make. The machines also cover a wide spectrum in the mechanical field such as the the FLOW Water Jet, which cuts a wide variety of material ranging from titanium to wood without utilising heat, thus saving electricity. This makes it possible to cut a wide variety of materials.

With the new machinery now available, the Instrumentation Division is able to perform high quality and quantity production with precision.

“The advantage of the machinery is that it stimulates production, and is much faster and more accurate than the conventional way of doing things,” said Pieter Botes, Head of the Division.

Botes explained that, by having students and professional artisans at the university design and manufacture equipment, costs are reduced when compared with the expensive nature of equipment and tools found in the market. In addition, “the machines broaden the scope of research conducted” said Botes. The technical dynamics of the machinery advances the scientific knowledge needed to operate it, so bridging the gap between theory and practice.

The Central University of Technology, Signs Division Bloemfontein, Product Development Technology Station (PDTS), Maizey’s, and Knottco Truckparts are some of the university’s trade partners.

The workshop collaborates with the Chemistry, Physics, Microbiology, Botany, Agriculture, and Electronics departments, as well as the Institute of Groundwater Studies at the UFS, and others. These departments receive services in the form of pipette stands, containers for test tubes, bottles, laboratory trolleys, stands for cadavers for Anatomy, pump repairs, stainless steel bailers, filaments, and heaters.

The Instrumentation Division is, therefore, a vital support unit for the Faculty of Natural and Agricultural Sciences as well as the university at large.

Companies, institutions, or individuals who need the Division’s expertise may contact Pieter Botes on botespds@ufs.ac.za.

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