Our client is a leading Denmark-based pharmaceutical company. They develop drugs for the treatment of severe neurological and neurodegenerative diseases and their success is partly due to the close cooperation with leading neurologists and neuroscientists.
They have a rigourous set of quality criteria for selecting their suppliers. The pharmaceutical company needed a GMP-compliant air conditioning solution for the storage, preparation and provision of raw materials in the manufacturing process.
DENIOS impressed with its outstanding consulting competence, a concept tailored to their specific needs, and a holistic solution from planning to delivery.
Chromatography resins are used for protein purification and must be systematically stored and kept in a precisely defined temperature range. The defined temperature ranges must be adhered to at all times and documented in gMP compliant. Due to the flammability of the raw materials, fire and explosion protection measures must be provided.
The pharmaceutical manufacturer found the right partner for advising, planning and supplying a corresponding plant in DENIOS. For the large amount of raw material, mainly barrel containers, the customer wanted to invest in twenty climate chambers in a fail-safe, redundant design. The concept envisaged by the customer would have meant very high costs, large space requirements and a lot of maintenance. After a detailed needs analysis, DENIOS engineers were able to significantly streamline the concept and drastically reduce the planned investment amount.
The concept developed by DENIOS is based on five climate chambers. Partition walls create four separate climate rooms inside the five chambers. Each climate chamber is extra deep and accessible from both sides. Cooling is carried out for each chamber via a redundant split air conditioner, which intelligently distributes the air-conditioned air to the individual rooms. The number of air conditioners has also been significantly reduced. Two temperature ranges were defined, +5 °C (-3 K) and + 20 °C (-5 K), which can be represented by each of the five chambers.
The four sub-rooms of the chambers have trace heaters, which ensure the exact temperature control. In this way, fluctuations (e.g. through material handling) can be reacted quickly. Technical ventilation systems counteract rising temperatures and can allow cold air to flow in if necessary. In addition, each room is monitored by gas detector. If the gas concentration rises above a defined limit value, the technical ventilation is switched on and provides an air exchange.
Compared to continuous ventilation, energy costs are thus significantly reduced. For the fulfilment of the fire protection concept, the climate chambers have a fire protection insulation, grade A1 (EI 120). Smoke detectors monitor the interiors and report an alarm in case of an emergency. Installed sprinkler systems are used for rapid firefighting.
DENIOS has critically examined the system planning prescribed by the customer and thus came to a significantly more efficient solution. With the needs analysis and professional planning of DENIOS, the customer was shown a clear savings potential with the same level of performance, quality and safety. During a 6-week factory acceptance test, an external auditor commissioned by the client was able to convince himself of the plant quality.
Due to the intelligent system control and optimal design of the power-consuming components, the customer achieves a high savings potential in terms of energy and maintenance requirements.
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