{ENGLISH} CHAPTER 1 PHARMACEUTICAL MANUFACTURE FACILITIES – PART 2

CHAPTER 1 PHARMACEUTICAL MANUFACTURE FACILITIES – PART 2

 

Pharmaceutical Manufacture Facilities

The production process of drugs can be mainly divided into:

“API process”, which produces active pharmaceutical ingredients of drugs. “Formulation process”, which turns API into an appropriate dosage form. “Packaging process” packages the dosage form to be completed as the finished product.

In correspondence to the above processes, manufacturing facilities can be divided into:

API Facility (includes the equipment for the API Process) Dosage Form Facility (includes the equipment for the formulation process and packaging process)

API Facility

API are mainly manufactured by chemical synthesis/ microorganism/ cell cultivation.

Synthetic APIs

In terms of chemical synthesis, low molecular compounds are manufactured by synthesis, which we refer to as synthetic drugs. The manufacturing process generally includes the flow from reaction to crystallization to separation and drying.

To simplify the equipment and prevent contamination, a multi-purpose separation machine with a drying function is usually used to perform processes for separation, cake washing, and drying. The produced APIs are filled into containers to be then fed to the formulation facility.

Biological APIs

On the other hand, in biological API productions, the in vivo functions of microorganisms (such as E. coli or yeast) or cells (insect cells or animal cells) are utilized to produce a high molecular synthesis compound (polymer), such as a protein.

The manufacturing process of bio-drugs generally includes a flow of cultivation (crushing), cell separation, purification, and concentration.

Since animal cells do not have cell walls; there is no propagating concern exposed…