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Munters helps fulfilling FDA requirements

Strict climate control in weighing room is elegantly performed by a Munters ML Plus system.

The PolyPeptide Group works within all major peptide technologies and handle peptide production from small-scale (multi-10 mg) non-GMP batches to multi-10 kg (and larger) GMP manufacturing needs. The Group has more than 50 years' experience worldwide within the field of peptide development and manufacturing project.

In PolyPeptide's facility in Malmö, Sweden, large scale GMP manufacturing for both SPPS (Solid Phase Peptide Synthesis) and LPPS (Liquid Phase Peptide Synthesis) projects takes place. The facility has successfully undergone approval inspections by the US FDA – all for GMP manufacture.

Several Munters dehumidifiers have already for years been creating optimal climate conditions in various applications in the Swedish facility. To fulfill the requirements from the US FDA, a Munters ML Plus system was lately installed in a small weighing room in the Quality Department. Very strictly controlled conditions, identical to the production climate were required: 20°C/25% RH around the year. With the positive experience from existing Munters installations, PolyPeptide asked Munters to design a unit that could meet the FDA requirements. An ML Plus 420 was configured, and the elegant way to combine modules for pre and post treatment of the air was very much appreciated by PolyPeptide.

Apart from the basic module for dehumidification, the unit consists of modules for pre heating and cooling, post cooling and humidification. The small foot print of the unit was advantageous too, as the system was installed on the attic above the weighing room – among other air handling units.

Of hygienic reasons, the system runs as an open system. On warm humid days, the dehumidification process secures the low relative humidity needed, while on cold winter days, the humidifier prevents static electricity that would create problems during the extremely accurate and demanding weighing procedure. Hereby, the working safety is also improved, preventing particles from preparations or samples to infiltrate the air inhaled by the laboratory technician.

事实浏览

  • Strict climate control
  • Constant and controlled conditions around the year
  • Enables FDA approval
  • Improved working safety
  • ML Plus system provides small foot print

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除湿

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WELCOME TO THE FUTURE OF CLIMATE CONTROL. INTRODUCING MUNTERS AIRC.

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制药

医药产品是敏感的产品,例如粉剂、片剂、胶囊和诊断条带,在与空气中的水分接触后,往往会失去药效和保存期限。这些产品会粘在一起,发霉或碎裂。同时造成机器和管道堵塞,生产、运输和储存均受到阻碍。这是一个可以避免的时间和成本密集型情况。

食品和饮料

为高品质食物提供高优质空气。从农场到餐桌,蒙特全面控制气候条件,在节能并提升生产效率的同时确保更佳产品质量。

零售店和超市

过量潮湿空气进入零售店区域内可造成不舒适的存储环境。零售业在安装更加高效且高性能的空调系统以营造舒适、健康的工作和购物环境时,已实现了更高的销售额并降低运营成本。