An Argentine company specialized in the design and manufacture of equipment and products for filtration and handling of industrial fluids, announced an investment of $800 million to produce single-use sterilizing filter capsules, which are used by laboratories in critical processes such as the manufacture of injectable medications.
It’s about the signature FluidsControlwhose investment will allow to realize an import substitution a key input for the pharmaceutical industry. Sometimes these imported capsules, which laboratories use to filter and sterilize fluids, are reused given that there is no regulation that prevents this recycling, as company sources explained to Scope.
“This practice of reuse has risks and costs and it can be done because in Argentina it is not regulated. But to export yes there are regulations that require the use of single-use capsules in the production process,” they added.
“We are currently manufacturing the cartridges that are also used in the pharmaceutical industry, and the capsules will complete the portfolio of sterilizing filters for Pharma. This year we will also be launching the capsules on the market with an investment of $800 million between equipment, matrices and plant expansion”explained Ernesto Martínez, President of FluidsControl.
According to the businessman, there are several reasons why single-use capsules are recommended. one is reducing cross contamination risks. Single use eliminates the possibility of microbiological, chemical or particulate residues from previous batches that may not be completely removed during cleaning.
He also highlighted that reused capsules are prone to accumulating biofilms – communities of microorganisms – that can be difficult to remove, even with validated cleaning methods. “This is essential in the manufacture of injectable products, where any risk of contamination is critical”he remarked.
He also explained that bacteria retained from the previous batch represent a significant source of endotoxins if not properly removed. Proper management of this risk requires strict cleaning protocols, continuous validation and, in critical cases, the preference for single-use filtration systems. Endotoxins are potent pyrogens that can cause fever, septic shock, and other serious adverse reactions in patients, especially when injectable products are administered.
National production of inputs to facilitate the supply of pharmaceutical inputs
“Usually in Argentine industries Filters are reused due to cost issues or even lack of supply.. We know the number of contraindications that this implies. From our company we seek to revolutionize the industry with the national production of filters at competitive costs with the focus on improving the quality and health of people,” Martínez added.
Regarding production costs, the businessman explained that although reusing filters may seem like a viable option for reducing costs, the associated risks are significant and directly affect the quality of the final product. “The costs of controls to ensure safety in reuse are very high and do not justify the risk assumed”he warned.
Therefore, national production for the first time of this product will allow the local pharmaceutical industry to adjust to an internationally recommended practice for regulatory, technical and risk control reasons, particularly in the manufacture of injectable products.
“Another parameter to take into account is that, if you opt for an approach of reusing a filter capsule, you must consider that This process must be validated and the costs assumed, both validation and cleaning. The reuse of filter capsules requires robust cleaning and sterilization processes, which generates technical and economic challenges,” explained Franco Fasce, Validation specialist at FluidsControl.
“It is also a common mistake assume that a capsule is validated because its certificate of analysis declares tolerance to a certain number of autoclave hours, since this information is obtained under clean filter conditions, and in productive use it must be validated for each product and process specific,” Fasce completed.
Source: Ambito
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