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Munters helpsPolyPeptide Group meet FDA requirements

The PolyPeptide Group is involved in 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. PolyPeptide has more than 50 years of worldwide experience in the peptide development and manufacturing project field. Large-scale GMP manufacturing of SPPS (Solid Phase Peptide Synthesis) and LPPS (Liquid Phase Peptide Synthesis) projects takes place in PolyPeptide´s Malmö, Sweden facility. The facility has successfully passed US FDA inspections for cGMP manufacturing.

Need to fulfil FDA requirements

Several Munters dehumidifiers have been creating optimal climate conditions in various applications in the Swedish facility for many years.

A Munters ML Plus system was recently installed in a small Quality Department weighing room to fulfil FDA requirements.

Strictly controlled conditions, identical to the production climate, were required: 20°C/25% RH during the entire year.

Pleased with existing Munters installations, PolyPeptide asked Munters to design a unit that could meet FDA requirements. A ML Plus 420 was configurated. This elegant solution combined modules for pre and post air-treatment, which was very much appreciated by PolyPeptide.

Small footprint

Besides the basic dehumidification module, the unit consists of modules for pre-heating and cooling, post-cooling and humidification.

The small footprint of the unit was also helpful since the system was installed in the attic above the weighing room along with some air handling units.

The systems run as an open system for hygienic purposes. On warm humid days the dehumidification process secures the necessary low relative humidity, while on cold winter days the humidifier prevents static electricity that would create problems during the accuracy-dependent, demanding weighing procedure.

Worker safety is also improved, preventing preparation particles or samples to infiltrate air inhaled by laboratory technicians.

ML Plus - built with standard modules
The ML Plus concept is a compact standardised stand-alone dehumidification system with incorporated temperature and humidity control.

The ML Plus-system can be configured with a supply fan, humidifier, pre and post-coolers and heaters according to requirements.

The ML Plus system is built up in elements, assembled and tested at our factory - ready for immediate start-up on site.

Small footprint - easy installation
Standardisation has made it possible to minimise footprint measurements. This enables a simple integration of ML Plus into most moisture-sensitive production processes.

ML Plus can be delivered with a dehumidification capacity up to 17.5 kg/h and airflows up to 5,500 m³/h. The system is quick and easy to connect to existing pipes and ducts.

Punti chiave

  • Strict climate control
  • Constant and controlled conditions all year round
  • Enables FDA approval
  • Improved working safety
  • MLPlus-system provides small footprint

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