Trans­fer <span class="amp">&</span> Scale-Up

Trans­fer & Scale-Up

The pro­ce­du­re for sca­le-up depends on the tech­no­lo­gy employ­ed. For examp­le, with dry gra­nu­la­ti­on the sca­le-up can be con­duc­ted very logi­cal­ly as we know all the rele­vant para­me­ters. The key influ­en­cing fac­tors for­ce, gap and roll speed can be cal­cu­la­ted for sca­le-up and the sca­le-up pro­cess does not invol­ve many tri­als. Whe­re­as with high she­ar gra­nu­la­ti­on the influ­en­cing fac­tors are known, too, but can­not be fore­cast for the sca­le-up as easi­ly. In gene­ral, the pro­cess requi­res more tri­als to be con­duc­ted. Howe­ver, our expe­ri­ence comes into effect here and allows us to keep the num­ber of tri­als and the mate­ri­als input to a mini­mum. In terms of com­ple­xi­ty, flu­id bed gra­nu­la­ti­on is in-bet­ween dry gra­nu­la­ti­on and high she­ar granulation.

Fol­lowing a suc­cess­ful small sca­le deve­lo­p­ment we are hap­py to per­form the sca­le-up, too, and will take care of a smooth tran­si­ti­on to your pro­duc­tion department.

Examp­le Procedure

Here is a pos­si­ble out­line for the deve­lo­p­ment of dry granules:

  1. We deve­lop the dry gra­nu­les on the Styl‘One Evo with mini­mal mate­ri­als input. At first, we pro­du­ce so-cal­led gra­nu­la­ti­on tablets and grind them with a hand mill. This hand mill pro­du­ces the same gra­nu­le pro­per­ties as a Gert­eis Pac­tor (see also For­mu­la­ti­on Deve­lo­p­ment). During sub­se­quent table­ting tri­als we can alrea­dy simu­la­te the tar­get table­ting press.
  2. For the sca­le-up, we now trans­fer the gra­nu­la­ti­on tablets to the rol­ler com­pac­tor. With our Gert­eis MINI-PAC­TOR® we pro­du­ce small amounts of gra­nu­les using various set­tings. Usual­ly, we requi­re 500 g to 1 kg of pro­duct for this stage.
  3. We com­pa­re the dif­fe­rent spe­ci­men visual­ly and hap­ti­cal­ly by piling them up  manu­al­ly on a work sur­face. In doing so we get an impres­si­on of the gra­nu­les‘ flowa­bi­li­ty and strength. On this basis we select the best candidates.
  4. For the selec­ted can­di­da­tes we then pro­du­ce 2 – 5 kg of gra­nu­les (depen­ding on the desi­gna­ted rota­ry table­ting press) to veri­fy their tableta­bi­li­ty on a rota­ry table­ting press and to test their flowability.
  5. The last step is the trans­fer to the actu­al rota­ry table­ting press. We can cal­cu­la­te the rol­ler compactor‘s sca­ling (e. g. from MINI-PAC­TOR® to MACRO-PAC­TOR® and per­form the ver­nier adjus­t­ment as part of vali­da­ti­on batches.

Natu­ral­ly, we also do sca­le-ups for wet gra­nu­la­ti­on, and we offer sca­le-up sup­port for for­mu­la­ti­ons that were deve­lo­ped by others.

 

samples of various granules

Once the sca­le-up para­me­ters are deter­mi­ned, we offer the opti­on that we defi­ne the ent­i­re manu­fac­tu­ring pro­cess inclu­ding all necessa­ry qua­li­ty para­me­ters. It goes without say­ing that we coor­di­na­te this clo­se­ly with your pro­duc­tion faci­li­ty. As ear­ly as we start deve­lo­ping a for­mu­la­ti­on we keep an eye on a future migra­ti­on to a scala­b­le pro­duc­tion pro­cess. As a result, the trans­fer to pro­duc­tion should work out smooth­ly. Our claim is to deve­lop for­mu­la­ti­ons fit for production.

For the final sca­le-up tri­als or for the han­do­ver to pro­duc­tion we pre­fer to come on-site. All necessa­ry pre­tri­als can be per­for­med in our facilities.

We also offer on-site sup­port in the con­text of pro­duct trans­fers to ano­t­her machi­ne or ano­t­her pro­duc­tion site. For each case, we con­si­der indi­vi­du­al­ly if a set of pre­tri­als is advi­s­able to spa­re your pro­duc­tion capa­ci­ties. This makes sen­se espe­cial­ly if we can­not be sure in advan­ce whe­ther the trans­fer to ano­t­her machi­ne is theo­re­ti­cal­ly feasible.
We will love to exp­lain more in a free initi­al con­sul­ta­ti­on.