Cleaning up SA’s pharmaceutical industry
05 December 2018 | Web Article Number: ME201812945
SOUTH Africa is a major manufacturing and export hub for the pharmaceutical industry and is subject to not only local legislative oversight but also to those of the countries the medicines or medical equipment is destined for.
The pharmaceutical industry is also one of the sectors on which government is pinning its hopes to help resuscitate an ailing economy. By 2019, the government envisages South African exports of pharmaceutical products will increase to approximately $526 million.
As the opportunities in this sector increases, so too will the need for greater oversight, by both the industry as well as the government. That’s according to Luca Di Siervi, Nilfisk’s Business Development and Key Account Manager – Pharmaceutical, who added that with this level of scrutiny, hygiene, safety and close collaboration between cleaning solutions providers and pharmaceutical companies is crucial.
“We need to have an integrated approach when it comes to our machines and provide the right level of performance otherwise they will not perform at optimum levels and this can impact on the final product.”
As with most sectors, technology has made it easier to execute and track performance of cleaning machines.
“What is becoming the norm in the pharmaceutical sector is to have machines that are as easy to use as possible. We endeavor to make our machines easy-to-use, which means less paperwork in terms of instruction manuals and this leads to less costs,” Di Siervi said.
In South Africa, the manufacturing of pharmaceuticals is guided by Good Manufacturing Practices (GMP) and overseen by the Department of Health.
The World Health Organization (WHO) has established GMP guidelines in detail from which many countries, including South Africa, have formulated their own GMP.
Two of the main rules of GMP in the production of pharmaceuticals which pertain to cleanliness and hygiene state that facilities must be cleaned and high standards of hygiene and quality must be maintained from procurement to product. Additionally, cross-contamination must be prevented by temperature and humidity-controlled environments and by restricting entry to authorized staff with proper work gear.
“What is important to understand is that medicines produced in South Africa and exported to the US, for example, are also under scrutiny of the US’s Food and Drug Administration (FDA),” said Di Siervi.
The FDA has to make sure the medicines they import from elsewhere conforms to their rules and regulations.
“The pharmaceutical company has to provide documents that the cleaning of the equipment and the room where it is manufactured has been through a process of validation.”
Di Siervi said Nilfisk works closely with its clients in the pharmaceutical sector to ensure quality control.
“We analyse our clients’ requirements and will assist with a customized cleaning solution and machines that are suited to their specified application.”
Di Siervi said contamination – dust or otherwise - in the spaces where the pharmaceuticals are produced is high on the list of challenges faced by the industry.
The manufacturing process of any type of medicinal product is often complex if one considers the number of phases involved and the different substances being handled: from active ingredients handling to tabletting, right through to the finished packaged product.
The substances used can sometimes pose a risk to the health of the operator and are often characterised by a high intrinsic value. So, guaranteeing the highest levels of hygiene and safety is vital, in order to avoid any kind of contamination, exposure or direct contact with such products as well as ensure the highest productivity.
Vacuuming is an integral part of the medicine production process and Nilfisk’s range of industrial vacuum cleaners are specifically designed to be used to clean inside and outside process machines.
It helps to avoid cross contamination, maintains the condition of the process machine – thereby extending its life span - collects and contains all kinds of waste and dramatically reduces cleaning time.
“We are interacting with the end user – those who are going to be using the machines in order to create a clean environment.”
Di Siervi said that for the South African pharmaceutical sector to thrive it needed to continuously look at ways of enhancing its processes and protocols, which include an environment free of contaminants.