Kloss S, Müller U, Oelschläger H
Jenapharm GmbH & Co. KG, Institut für Pharmazie der Friedrich-Schiller-Universität, Jena, Germany.
Pharmazie. 2005 Sep;60(9):661-4.
Facilities for the manufacturing of pharmaceutical drug substances on the pilot-plant and the industrial scale as well as chemical reactors and vessels used for chemical work-up mainly consist of alloyed stainless steel. The influence of the alloy composition and the surface condition, i.e. of the roughness of the stainless-steel materials, on the adsorption of structurally diverse steroidal substances and, hence, on the quality of the products was studied. In general, stainless-steel alloys with smooth, not so rough surfaces are to be favored as reactor material. However, it was demonstrated in this study that, on account of the weak interaction between active substances and steel materials, mechanically polished materials of a medium roughness up to approx. 0.4 microm can be employed instead of the considerably more cost-intensive electrochemically polished stainless-steel surfaces. The type of surface finishing up to a defined roughness, then, has no influence on the quality of these pharmaceutical products. Substances that, because of their molecular structure, can function as "anions" in the presence of polar solvents, are adsorbed on very smooth surfaces prepared by electrochemical methods, forming an amorphous surface film. For substances with this structural characteristics, the lower-cost mechanically polished reactor materials of a medium roughness up to approx. 0.5 microm should be used exclusively.
中试规模和工业规模的药物原料药生产设施以及用于化学后处理的化学反应器和容器主要由合金不锈钢制成。研究了合金成分和表面状况，即不锈钢材料的粗糙度，对结构多样的甾体类物质吸附的影响，进而对产品质量的影响。一般来说，表面光滑、不太粗糙的不锈钢合金更适合作为反应器材料。然而，本研究表明，由于活性物质与钢材之间的相互作用较弱，粗糙度达约0.4微米的中等粗糙度的机械抛光材料可替代成本高得多的电化学抛光不锈钢表面。因此，达到规定粗糙度的表面处理类型对这些药品的质量没有影响。由于其分子结构，在极性溶剂存在下可作为“阴离子”起作用的物质，会吸附在通过电化学方法制备的非常光滑的表面上，形成无定形表面膜。对于具有这种结构特征的物质，应仅使用粗糙度达约0.5微米的中等粗糙度的低成本机械抛光反应器材料。
