Mixer dryer synthesis reactors for active pharmaceutical ingredients (API)

In the production of pharmaceutical ingredients, the efficiency of the mixing technology is of crucial importance, regardless of whether the reactions are biotechnological or chemical.

In the production of pharmaceutical ingredients, the efficiency of the mixing technology is of crucial importance, regardless of whether the reactions are biotechnological or chemical. The ultimate goal is complete chemical/biochemical conversion.

Only when the entire reactor content is completely flowed through/mixed can the substances involved in the reaction come into contact with each other, uniformly distributed. Only then can a uniform temperature level be achieved in the reactor. Process temperatures can only be reliably controlled in this way.

Yield, quality and production safety depend directly on the efficiency of the mixing process.

Biofermenters/ bioreactors/ mixers/ fumigation system for API production

In this case, the starting materials are usually in the form of suspensions or lipophilic emulsions. For biotechnological conversions, the even distribution of oxygen, nutrients, enzyme catalysts and nutrient solutions is crucial. For a homogeneous growth of the microorganisms, the temperature must be controlled to within a tenth of a degree. The cell growth of the microorganisms in the nutrient solution leads to altered flow properties. Anchor stirrers or propellers are unsuitable as stirring elements when the viscosity increases.

Biotechnological synthesis of active pharmaceutical ingredients (APIs) is less common than chemical synthesis

Nevertheless, biochemical processes will become more important in the future. This is due to three facts:
• Mild reaction conditions mean high energy efficiency and cost-effective apparatus and plant construction. In turn, a germ-free production environment must be ensured.
• Enzymes are biodegradable
• Unwanted by-products are usually less hazardous and can be disposed of cheaply. They are normally far less hazardous than reaction residues from chemical production.

Well-known pharmaceutical active ingredients produced using biological processes include insulin, erythrocytes, monoclonal antibodies, growth hormones, antibiotics, cholesterol-lowering drugs, vitamins (B12 and C), heparin and many vaccines against COVID. The more complex the molecular structures are, the more likely it is that so-called biotechnological production processes will be used. This is the case, for example, in personalised medicine.

Little research has been done on bio-similar microbial growth at boiling temperatures under high pressure and in a sulfuric acid environment (hot springs in the deep sea). Catalysts are also suspected here, but little is known about them.

Semisynthetic APIs

Some active pharmaceutical ingredients, such as antibiotics, semisynthetic opiates or steroid hormones, are produced by a combination of biological and chemical processes. The biological process usually takes place first. This method allows complex molecular structures to be built efficiently. Further chemical processing can improve purity and bioavailability by using organic solvents (polar and non-polar). There are also semi-synthetic drugs that are composed of synthetic and biological active ingredients.

amixon® supports your customers from the outset...

and, if desired, until successful commissioning. It is often difficult for manufacturers of active ingredients to find the optimal synthesis reactor and the right manufacturer. amixon GmbH provides support with a large technical centre and numerous pilot plants - a valuable aid in selecting the right system.

In addition, amixon helps to meet important industry standards with established solutions:
• ATEX (ATmosphères Explosives) European legislation to prevent fires and explosions.
• OSHA (Occupational Safety and Health Administration; US legislation on occupational safety)
• FDA (Food and Drug Administration)
• GMP compliance (Good Manufacturing Practice)
• Support for full validation (Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification)
• Internationally recognised automation standards

Read more on the blog: