API making equipment must observe rigorous quality control standards across the entire manufacturing process. The pharmacodynamic properties of active pharmaceutical ingredients API make them highly sensitive to their environment, making API manufacturing and production a tightly regulated field.

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Containment technology for making API

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When selecting production equipment for a production plant, it is important to talk to someone with experience in your field. Our industry experts have experience with various industrial applications. We’d love to help you!

Manufacturing API from a natural, synthetic, or semi-synthetic base

Synthetic APIs are developed from chemical conversions in a lab. Natural APIs, on the other hand, are derived from plants or animals and then purified. Semi-synthetic options stand somewhere in between. They are extracted from natural sources but then biochemically converted into the final Active Pharmaceutical Ingredient API.

The three main groupings of active pharmaceutical ingredients, however, employ similar extraction methods. The intermediaries are extracted from raw materials in a reactor before passing through a series of filtering and centrifuges for isolation and purification. Depending on the finished products, API are milled or freeze-dried before packaging. Distillation is also a key process used in the manufacturing of APIs. The distillation process is used to purify and isolate the desired compound from a complex mixture of chemicals.

Follow GMP standards for your API making equipment

Your API processing equipment must have official certification for reaching production standards.

There are multiple protocols, but Good Manufacturing Practices (GMP) are the global benchmark in pharmaceutical product certification. The World Health Organization (WHO) issues guidelines in this department but other jurisdictions such as China, the EU, and Canada have developed their own GMP.

Classification of API must be clearly displayed on your product label

There are hundreds of active pharmaceutical ingredients used for a wide range of finished pharmaceutical products. Orphenadrine, for example, is the main API found in muscle relaxants, while antivirals are composed of oseltamivir carboxylate. The pharmacological effects of antidepressants are driven by active ingredients such as memantine, amitriptyline, and citalopram. APIs come in various forms such as powders, liquids, tablets and capsules.

The WHO keeps and updates a catalog of all API, ensuring common application and labeling across all pharmaceutical manufacturing markets. The names of these ingredients are non-proprietary and must be displayed under the brand names of packaged pharmaceutical products.

HPAPI manufacturing requires expert containment solutions

The API sector is moving in the direction of highly potent active pharmaceutical ingredients (HPAPI). These special components deliver a stronger drug efficacy than regular API and at a reduced dose. Medicines made from HPAPI minimize side effects and are an important development in the treatment of chronic conditions.

Manufacturing HPAPI, however, raises a series of considerations. Producers must ensure strict handling and cleansing procedures to adhere to occupational exposure limits (OEL) and rigorous quality control to keep their workers safe.