New freeze dryer

The lyophiliza­tion sys­tem can be used to sta­bi­lize ther­mo­la­bile and del­i­cate active ingre­di­ents, like onco­log­i­cal med­ica­tions, vac­cines or anti­bod­ies. The sys­tem, which was devel­oped at the company’s Aus­tri­an sub­sidiary Schoeller-Bleck­mann Medi­z­in­tech­nik (SBM), rounds out Bosch’s port­fo­lio for phar­ma­ceu­ti­cal liq­uids. Its mod­u­lar design makes the GMP-com­pli­ant freeze dry­er suit­able for the pro­duc­tion of small batch­es for clin­i­cal tri­als, as well as for medi­um pro­duc­tion batches.

Reliable stabilization of pharmaceuticals

Dur­ing the freeze dry­ing process, water is extract­ed from the drugs by means of sub­li­ma­tion with­out affect­ing its prop­er­ties. Depend­ing on the indi­vid­ual prod­uct, the shelf life can be extend­ed many times over. The dry, porous lyo cake can be quick­ly and eas­i­ly recon­sti­tut­ed short­ly before use by adding ster­ile water.

Optimum shelf design

As a result, the shelves were pro­duced using laser weld­ing tech­nol­o­gy, which ensures a 100 per­cent con­trolled, auto­mat­ed and repro­ducible man­u­fac­tur­ing process. This in turn is essen­tial for con­sis­tent and reli­able prod­uct qual­i­ty. More­over, by using thin­ner sheets, the weight of the shelves has been sig­nif­i­cant­ly reduced com­pared to alter­na­tive pro­duc­tion process­es. Thanks to this weight reduc­tion, less mass has to be cooled and heat­ed, which has a pos­i­tive effect on ener­gy consumption.
Anoth­er advan­tage of the sys­tem is the homoge­nous tem­per­a­ture dis­tri­b­u­tion in the shelves. The inter­nal chan­nel­ing and flow veloc­i­ty were opti­mized on the espe­cial­ly devel­oped test bed to ensure con­sis­tent heat exchange. The tilt­ing shelves ensure rapid clean­ing: the slight tilt enables water droplets to quick­ly drain from the sur­face, short­en­ing the clean­ing and dry­ing time. The tilt angle also improves the per­for­mance of the CIP noz­zles, reduc­ing water consumption.

High flexibility

The freeze dry­er was devel­oped based on the user-expe­ri­ence approach, tak­ing know-how gained from cus­tomer projects and dis­cus­sions with equip­ment pro­duc­ers and phar­ma­ceu­ti­cal man­u­fac­tur­ers into account. The robust sys­tem meets Bosch’s high qual­i­ty and safe­ty stan­dards and fits seam­less­ly into the company’s com­pre­hen­sive phar­ma port­fo­lio. The match­ing inter­faces ensure rapid and seam­less con­nec­tion to the upstream fill­ing machine with iso­la­tor tech­nol­o­gy, the down­stream cap­ping machine, inspec­tion sys­tem and sec­ondary pack­ag­ing station.