Klimastyring – overholdelse af GMP-krav

Xellia Pharmaceuticals er en førende producent af aktive medicinalingredienser (API’er) og specialiserer sig i fermenteret antibiotika. Xellia har sine egne produktionsfaciliteter i Danmark, Norge, Ungarn og Kina, og deres API’er kan fås i store mængder eller som Sterilized Finished Dosage Forms (FDF’er). I mange år har Munters været en betroet leverandør af affugtningssystemer til tablettering og andre anvendelsesområder inden for laboratorier. Takket være positive oplevelser fra tidligere installationer blev Munters kontaktet, da Xellias’ renrum til vejning af pulverprodukter for nyligt skulle opdateres. Da alle Xellias’ faciliteter overholder GMP-kravene, skal deres ClassB-renrum have en præcis styring af både temperatur og luftfugtighed, og Munters blev bedt om at designe den optimale klimaløsning til disse rum. De valgte MLPlus og MXPlus-systemer er designede til at blive montreret i miljøer med høje krav til belastning, energieffektivitet og hygiejne. Standardmoduler til for- og efterkøling kan tilføjes alt efter de reelle specifikationer, og de passer alle på en almindelig basisramme med rengøringsvenlige overflader og et elegant design. Ved at vælge et Munters Plus-system nyder kunden fordelen af kun at have én leverandør til både affugtning, for- og efterkøling, filtrering samt befugtning. Systemet er kompakt og dermed fleksibelt i designet og sammensætningen af de nødvendige moduler. Hos Xellia Pharmaceuticals sikrer klimastyringsløsningen fra Munters ikke kun de strenge krav til denne renrumsklassifikation, men løser også et praktisk problem. Uden affugtning kan vejningsprocessen i renrummene blive alvorligt påvirket af udendørs vejrforhold, hvilket kan forårsage, at produktionen bliver forstyrret eller udsat. Nu er klimaet i renrummene fuldstændigt upåvirket af udendørs variationer i temperatur og luftfugtighed, og produktionen kan blive planlagt meget præcist.

Clean room updates needed

Xellia Pharmaceuticals has 370 employees working in Copenhagen, Denmark, with production running nonstop. For many years, Munters has been the trusted supplier of dehumidification systems for tabletting and lab applications. Xellia´s positive experience with previous Munters installations led them to contact Munters when their powder product clean rooms needed to be updated.

The Munters solution

Since Xellia’s facilities are GMP compliant their Class-B clean rooms require strict temperature and humidity control. Munters was asked to design the optimal climate solution for these rooms. The selected MLPlus and MXPlus systems are designed to fit into environments with high demands on carbon footprint, energy efficiency and hygiene. Pre and post cooling standard modules can be added according to actual specifications and all fit on a common base frame with elegant design and cleaning-friendly surfaces. The units were designed to fit into the existing Xellia AC system, maintaining 20°C/ max. 20% RH conditions in the clean room. In the system´s pre-cooler module, process air is cooled and dehumidified to 13°C/9.4g/kg and led to the dehumidifier that reduces water content to less than 2.5g/kg. Temperature increase created by the dehumidification process is lowered by a post-cooler from 40°C to 20°C, with air led to the ducting system. HEPA filtration ensures that clean air is supplied to the clean rooms Air used for rotor reactivation is filtered by a EU5 filter. Wet, warm air from the dehumidification process is exhausted outdoors. Why Munters? By choosing a Munters Plus system, Xellia benefits since they have only one supplier for both dehumidification, pre and post-cooling/heating, filtration and humidification. The system is compact and flexible in the design and composition of needed modules. A satisfied customer Munters climate control solution for Xellia Pharmaceuticals not only met the strict demands for clean room classification but also solved a practical problem. Weighing process clean room production will not be interrupted or postponed anymore by bad weather conditions thanks to Munters dehumidification solutions. Clean room climate is now totally unaffected by outdoor variations in temperature and humidity and production can be precisely planned. Very happy with the Munters climate solution, Xellia Pharmaceuticals has appointed Munters supplier for their next clean room refurbishment.