製藥產業的應用
壓片製程
壓片製程是製造藥物產品最重要的過程,需要使用可與產品直接接觸的壓縮空氣。壓縮空氣會直接與壓片機製成的產品接觸,以去除灰塵或篩走瑕疵品,因此需要採用無油和乾燥的空氣,否則壓製的片劑可能會膨脹。壓縮空氣也可用於為壓片機上潤滑劑,使片劑更容易彈出。
製藥的初始階段使用壓縮空氣混合粉末混合物和/或生產用於壓片機的顆粒,而壓製之後的階段,即所謂的包衣和/或包覆,也需要利用壓縮空氣。常見的做法是採用流體床過程,即運用氣流讓藥片懸浮並持續運動,並使用噴嘴均勻濕潤藥片再進行乾燥,而壓縮空氣在這個工法中作為霧化空氣使用。
除了消費者的健康風險外,片劑製造過程常見的問題是片劑表面凹凸不平、裂開、破裂或顏色變化,潮濕和被油污染的壓縮空氣則是導致這些狀況的原兇。由於對壓縮空氣的要求相當嚴格,因此建議採用1-1-1品質等級的壓縮空氣。
Clean room
The production of medicinal products takes place partly in clean rooms, and some of the production steps there require compressed air. Compressed air can be used in all clean room classes. It can occur as an energy carrier in motors and pumps, for example. In these cases, the compressed air used does not come into contact with the product, but it must comply with the quality of the ambient air into which it is released. In other words: the compressed air should correspond at least to the air quality of the respective clean room class into which it is released. The requirements are worded in quite concrete terms in the “FDA Guidances for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice”.
In the case of clean room applications, compressed air is used for drying the washed primary vessels, before filling with the product as well as for filling liquids in accordance with the blow-fill-seal method. It is important that no germs and particles are contained in the compressed air.