Klimastyring sikrer overholdelse af FDA-krav

PolyPeptide Gruppen arbejder inden for alle større peptidproduktionsområder, fra mindre (multi-10 mg) ikke-GMP portioner til multi-10 kg (og større) GMP-produktionskrav. Gruppen har mere end 50 års erfaring worldwide inden for peptidudvikling og produktionsprojekter. På PolyPeptides fabrik i Malmö, Sverige, arbejder man med større GMP-produktion til både SPPS (Solid Phase Peptide Synthesis) og LPPS (Liquid Phase Peptide Synthesis) projekter. Fabrikken har med stor succes gennemgået godkendelseseftersyn af det amerikanske FDA – alle for GMP-produktion. I mange år har flere Munters affugtere allerede skabt optimale klimaforhold i diverse anvendelsesområder på den svenske fabrik. For at overholde kravene fra det amerikanske FDA blev der for nyligt installeret et Munters ML Plus-system i et lille vejerum i Kvalitetsafdelingen. Meget præcist styrede forhold, identiske med produktionsklimaet, var påkrævede: 20°C/25% RH året rundt. Med positive erfaringer fra eksisterende Munters installationer bad PolyPeptide Munters om at designe et anlæg, der kunne imødekomme FDA-kravene. Et ML Plus 420-anlæg blev konfigureret, og den elegante måde at kombinere moduler til for- og efterbehandling af luften på var meget værdsat af PolyPeptide. Bortset fra basismodulet for affugtning består anlægget af moduler til forvarmning og -køling, efterkøling samt befugtning. Anlæggets minimale belastning var også en stor fordel, da systemet var installeret på loftet oven over vejerummet – blandt andre luftbehandlingsanlæg. Af hygiejniske årsager fungerer systemet som et åbent system. På varme, fugtige dage sikrer affugtningsprocessen den nødvendige lave relative luftfugtighed, mens den på kolde vinterdage forhindrer statisk elektricitet, som kan skabe problemer under den ekstremt præcise og krævende vejningsproces. Hermed bliver arbejdssikkerheden også forbedret, da partikler fra præparater eller vareprøver bliver forhindret i at infiltrere luften, som indåndes af laboratorieteknikeren.

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.