How to layout pharmaceutical manufacturing equipment

1.      Pharmaceutical manufacture facilities

The production process can be mainly divided into “API process”, which produces active pharmaceutical ingredients of drugs, “formulation process”, which turns APIs into an appropriate dosage form, and “packaging process” which packages the dosage form to be completed as the finished product. In correspondence to above processes, manufacture facilities can be divided into API facility, and dosage form facility. Corresponding to each production process, there will be suitable facility.

1.1.  API facility

APIs are mainly manufactured by chemical synthesis or microorganisms or cells cultivation.

a. Synthetic APIs:

The manufacturing process generally includes the flow from reaction to crystallization, to separation and drying. In view of simplification of the equipment and preventing contamination, a multi-purposed separation machine with 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.

b. Biological APIsAPIs:

It generally includes a flow of cultivation, (crushing), cell separation, purification, concentration. Normally, each stage of production will have appropriate equipment.

1.2.  Drug product manufacture facility

In the manufacturing process of the drug products, the active pharmaceutical ingredients are further formulated by adding excipients or other components for the adjustment of the drug concentration or stability to be processed into a finished dosage form, and then packed in an appropriate way and shipped. As mentioned above, the dosage form varies according to product, and therefore, the structure of the manufacture facility or equipment also varies depending on the dosage form.

2.         How to layout equipment

The material flow is an issue of manufacturing solid dosage products in terms of equipment construction. Equipment layout varies greatly depending on how to handle the powder and a number of chemicals. Basically, materials are charged into the top of a machine and discharged from the bottom of it. If machines are arranged horizontally, it is necessary to have measures to lift the components and transfer it between the machines. And, it can be such equipment that is flexible to be used in multi production plants. On the other hand, there are equipment that are arranged vertically, used as transferring equipment by gravity for powder processing (see Fig).