Equipped for Annex 1 with SWS hot water shower sterilizers from SBM!

The new EU GMP Annex 1 addresses terminal sterilization to a greater extent than the previous version. Chapter 8.64 highlights the sterilization of pharmaceutical liquids in closed containers. Among other things, the focus is on even distribution of the hot water in the system. This is no problem for customers who rely on SWS sterilizers from Syntegon, since its subsidiary SBM has been using a unique water distribution concept for years.

Terminal hot water sterilization is used for pharmaceutical liquids in 100% sealed containers such as ampoules, vials, and bottles as well as infusion bags or blow-fill-seal products. Currently, two basic systems are used to distribute the hot water evenly across the product. One system uses a so-called spray frame, which sprays the hot water via a large number of spray nozzles. The other one uses perforated water distribution trays, which sprinkle the water over or onto the product.

While both processes have their justification, the hot water shower technology developed by Schoeller Bleckmann Medizintechnik (SBM) has long been based on water distribution trays and ensures a particularly even water distribution and consequently a homogeneous temperature distribution. As a result, the hot water shower sterilizers type SWS from SBM already met the newly specified requirements in Annex 1 before publication – without any need for retrofitting.

Hot water shower: more than Annex 1-compliant

Chapter 8.64 requires that the heat transfer medium must reach all products evenly. In addition, the system should be routinely inspected to ensure that the water distribution system is not blocked and that the drains are free from contamination. Thanks to their unique water distribution and sprinkling system, SBM sterilizers not only enable continuous, homogeneous distribution of hot water and temperature. They also completely avoid the use of spray nozzles. The individual spray nozzles would need to be removed regularly and their functionality checked, which leads to increased maintenance costs. Moreover, there is always a certain residual risk of blockage when using spray nozzles. The entire water distribution system of SWS sterilizers, in contrast, is very easy to inspect and clean. It only requires a simple visual inspection of the water distribution trays and the drainage sieve.

The blockage risk of the perforation in the water distribution trays is also very low, as the drain sieve collects any large particles that enter the system when loading the sterilizer. The perforation in the water distribution trays further allows particles that are not collected to pass through due to their size. SBM sterilizers prevent yet another risk: a spray nozzle is responsible for a far larger base area than a single hole in the water distribution system from SBM. If a single spray nozzle fails, large areas or even products might not be supplied with hot water and, in the worst case, sterilization could be impaired.

SWS sterilizers: many further highlights

But these are by no means all advantages. For example, the special design and construction of the SWS sterilizers optimize the energy requirements for heating and cooling; energy recovery systems can further reduce requirements. Fast cycle times with shorter heating and cooling periods, especially for temperature-sensitive liquids, are not an issue for SBM sterilizers. High-performance pumps enable high water circulation and hence a uniform temperature increase. Various process options reduce the thermal load on temperature-sensitive products to a minimum. Individually calculated and adjustable support pressure prevents product deformation or breakage during sterilization. In addition, SBM offers detailed verification of the water distribution with subsequent documentation during machine construction.