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VDMA reports on the use of safety valves in vaccine production

As part of its reporting on current topics in the industry, the VDMA (German Engineering Federation) has published an article on the topic of "Safety valves in vaccine production". For this purpose, LESER has provided an insight regarding the cooperation with various pharmaceutical manufacturers.

“LESER contributes to the rapid build-up of the necessary production capacities with suitable safety valves for production plants for vaccine production. For LESER, the pharmaceutical industry is an important customer group, so the Clean Service product group was able to provide the right solution with short delivery times right from the start. The safety valves are required in the production plants to protect against impermissible overpressure, prevent damage to the plant and thus ensure the safety of people and the environment.

The customer requirement

To ensure that safety valves function reliably in vaccine production plants, they must be adapted to the specific requirements of this industry. High quality standards must be maintained in vaccine production to ensure that the vaccine is effective and harmless. The production of pharmaceuticals is therefore subject to strict approval procedures and guidelines such as Good Manufacturing Practices (GMP). Good manufacturing practices prescribe, among other things, the appropriate equipment and the use of flawless materials and containers. Accordingly, the equipment must be designed to reduce the risk of errors. In addition, thorough cleaning and maintenance must be made possible so that contamination, dirt accumulation and, in general, effects that degrade the quality of the product are avoided. 

The LESER Solution/Advantages

These requirements can be directly applied to the design and manufacture of safety valves. At LESER, these specific requirements of the pharmaceutical industry and thus also of vaccine manufacturers are met by the Clean Service product group. For this purpose, LESER Clean Service valves have the following differentiating characteristics:

  • The cleanability of the safety valves is decisively ensured by the design and the surface quality.
  • The design is free of gaps so that no dirt particles can adhere. The internal components are protected by an elastomer bellows. In addition, the blow-out chamber is designed to be self-draining so that no media residues can form and corrosion is avoided.
  • The inlet of the type used by vaccine producers has a very low dead space ratio of 1.5. The dead space ratio defines the ratio of the inlet length (L) to the diameter (D) of the inlet tube. The smaller it is, the better the cleanability. In addition, no medium can accumulate or deposit in the inlet area. Conventional safety valves have a ratio of between 4-5 here.
  • Furthermore, the surface quality also has an influence on cleanability. The surface roughness of the components in contact with the medium is decisive here, representing an optimum in a range from Ra 0.25 μm to Ra 1.125 μm. Within this range, the customer can select different surface packages from LESER and adapt them to his application. The valves for vaccine production have a surface roughness of Ra 0.75 μm.
  • The materials used must not release any harmful components into the medium, in this case the vaccine. This ensures that a flawless, uncontaminated product can be produced at the end. Only elastomer compounds that are approved according to standards such as USP (United States Pharmacopeia) are used for this purpose.
  • With the LESER delivery time promise, delivery of the 155 Top Runner variants is guaranteed within three weeks from the factory. In extremely urgent cases, a valve can also be replaced in just a few days.

The added value for the customer

By using the Clean Service valves in vaccine production, the customer can on the one hand be assured of the safety of his plant, so that even in critical plant situations the production of the vaccine is guaranteed in the long term. On the other hand, the design and materials used in the Clean Service product group support the cleanability and maintenance of the plant, so that production can run safely on a continuous basis."