The service program for the pharma industry

The first step can be to carry out a comprehensive review of the current state of your ventilation system and its specific components, from air inlet to air outlet.

After implementation of the measures proposed by us, we carry out a repeat inspection to check the intended achievement of objectives. As a further step, the focus is on determining the total germ count; this mainly comprises microorganisms. With regular hygiene inspections and the collection of airborne germs according to VDI 6022:2018, the risk of contamination can be reduced to a minimum.

We will be pleased to check your plant according to VDI 6022:2018 and carry out an initial or repeat hygiene inspection, including airborne germ measurements. All inspections can be carried out as part of an individual Viledon FilterCair service contract. We will happily provide you with further advice.

All our regular inspections or complete service and maintenance programs for ventilation systems and cleanrooms are accompanied by meaningful and audit-compliant reports. The individual inspections and analyses can form part of a Viledon FilterCair service contract and are individually adapted to the requirements of your system concept.

With our Viledon FilterCair air quality management service, we are the ideal partner. Our experienced service technicians are either masters or technicians trained to VDI 6022 Category A. All the work required in connection with your ventilation system is carried out professionally and efficiently by our experts. As well as hygiene inspections, special measurements and tests, we also organize filter changes including the delivery of high-quality Freudenberg filters. Simply get in touch and we will work with you to create a suitable concept for your needs.

Some glass fiber media can break during the start-up and shut-down process of your plant and thus release glass fibers into the air. These then settle in the subsequent registers or enter the spaces to be ventilated via the ventilation ducts, if no additional filter stage is installed. This cannot happen with filter media made from synthetic fibers – the nature of the material itself prevents this. We will be pleased to advise you on the correct choice of filter.

Various standards and guidelines regulate the filter classes for different ventilation system applications.

For example, ISO 16890 regulates the required filter classification and quality.

VDI 6022 stipulates requirements for air conditioning systems in planning, production, execution, operation and maintenance that ensure hygienic operation for the protection of people. This includes, for example, the use of microbiologically inactive filters, and that the filter pockets have a high inherent rigidity and are suitable for operation at up to 100% humidity. The filter classes that need to be used are also clearly defined.

In contrast, DIN 1946-4 regulates the operation of air conditioning systems in buildings and rooms in the healthcare sector. It also describes the inspection of HEPA filters.

EN 13779:2007 regulates the ventilation of non-residential buildings and contains general principles and requirements for ventilation and air conditioning systems and room cooling systems.

There are various aspects to consider when choosing the right filters. We will be pleased to assist you with advice and support.

Differently high pressure drops influence the energy consumption of the fan. Energy consumption can be significantly reduced by using energy-efficient air filters.

We can perform an energy analysis within the framework of a plant inspection. This involves checking individual components for their functionality. By means of an energy monitoring process, the current energy consumption can be precisely determined. In the course of a more detailed inspection, our experts inspect the complete ventilation system from a cooling capacity >12 kW according to § 12 of the German Energy Saving Ordinance (EnEV).
Using these values as a basis, we then draw up individual recommendations and optimization proposals aimed at reducing energy consumption effectively and in the long term.

For HEPA filters from filter class H 13 upwards, a performance measurement must be carried out by the filter manufacturer in accordance with EN 1822:2012. This involves passing defined aerosols through the filter. Particle counters measure their number before and after the filter and thus determine the actual separation efficiency.

Where HEPA filters are changed in a cleanroom, they must be checked by our trained Viledon FilterCair service personnel for possible leaks and to confirm that they fit tightly, among other things. These checks form part of the cleanroom approvals process according to EN ISO 14644.
 

Cleanrooms and associated cleanroom areas must be certified according to EN ISO 14644 before they are put into operation. Among other things, the standard regulates the respective specified degrees of air purity. Rooms are classified according to the number of particles per cubic meter of air. This ensures that the room complies with all clean air criteria.

Using a variety of measurements, we determine the ISO class of cleanrooms according to EN ISO 14644. When establishing the air exchange rate, it is necessary to ensure that the entire room volume is recorded and exchanged. Furthermore, we also determine the recovery time of the cleanroom, i.e. how long it takes for the cleanroom to clean itself in the event of increased local contamination. Depending on its area of application, a cleanroom is operated at either overpressure or underpressure. This must always be kept constant and permanently controlled.

We would be pleased to support you in the inspection and certification of your cleanrooms according to EN ISO 14644.