Company insight
Purification control technology at its best
When dealing with such tight safety margins within the pharmaceutical and blood treatment sectors, purification technologies become crucial not only for production, but for the health and safety of patients and end-users. BEA Technologies is committed to the highest efficiency of removal of bacterial endotoxins from pharmaceutical solutions and medical products.
T
he use of extremely pure water is one of the primary requirements for industries operating in the pharmaceutical and blood treatment fields. Although sterilisation techniques are consolidated and easy to implement today, water purification processes are still in development. With that in mind, BEA Technologies has designed and built the POSINYL filter elements, consisting of an enhanced Nylon 6.6 membrane with positively charged sites, which allow the adsorption of the bacterial endotoxins and reduction in the final concentrations levels to lower than those required by current legislation. The positive charge was increased by adding functional groups that enhance the attraction and absorption potential towards cellular fragments and particles marked by a negative charge. These functional groups are additives in compliance with the requirements imposed by the FDA and by other medical and pharmaceutical regulations. All the results of the biocompatibility tests performed are reported in the “Validation Guide” that is provided to users before online installation.
The right elements
The POSINYL filter elements are available with sterilising filtration degrees of 0.1μ and 0.2μ with a positive charge. Filtration tests already carried out have made it possible to recover whey that was heavily polluted by endotoxins at 227Eu/ml until the concentration of the same was reduced to a level considered acceptable by the user.
In another case, it was possible to restore a considerable quantity of polyvinylpyrrolidone that had been
polluted with 160Eu/ml of endotoxins. The first stage of filtration reduces the concentration by ten times. The second one generated a reduction to 5–7Eu/ml. As the final stage of filtration, filter elements with a filtration degree of 0.1μ were used, which allowed the concentration to be brought back to 0.13Eu/ml. At this point, the product was considered acceptable for the next stage of use.
Ready to optimise
For application purposes and to optimise the absorption capacity of bacterial endotoxins it is necessary to use the POSITRAK filter elements as pre-filters, which are charged with a positive charge, to start to improve the efficiency of retention of POSINYL and observe the following prescriptions: ■
Based on the experience carried out, BEA Technologies recommends a flow rate not exceeding 350– 360L/h for a typical module length of 10in.
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
BEA Technologies is a leading manufacturer of filtration systems since 1961 ■
For pH values between two and four or higher than eight, there is a less favourable condition for the absorption of the “endotoxins”.
■
The adoption of a 0.1μ-degree of filtration guarantees the retention of endotoxins with smaller dimensions if a higher level of safety is required due to the “critical requirements” of pharmaceutical production.
The sanitisations and steam sterilisations (at 121°C) performed on POSINYL filter elements did not affect the absorption capacity of the positively charged membrane. There was no release of the previously retained endotoxins nor the release of “endotoxins” produced by the destruction of bacteria and microorganisms retained by the 0.2μ membrane. ●
www.bea-italy.com/it 45
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