May 21, 2020

Types of API and Bulk Drug Isolators within the Standard Group of Companies

The Standard Group of Companies are a leading supplier of equipment in the chemical and pharmaceutical industry.

The API and bulk drug manufacturing business is a huge concern and supports all pharmaceutical operational processes across the globe.

The Active Pharmaceutical industry is also the conveyor by which active pharmaceutical ingredients are manufactured from raw materials through both chemical and physical means.

Active pharmaceutical ingredients or APIs can be defined as the chemicals used to manufacture pharmaceutical drugs.

The active ingredients (AI’s) are the substances that are biologically active within the drug and these are the specific components responsible for the effect it has on the person / persons taking them.

APIs are commonly referred to as ‘bulk pharmaceuticals and are commonly made in specific parts of factories are even different companies to actual formulation products.

Some medications may contain more than one active ingredient and depending on the complexity of the molecule required and the synthesis of APIs might need more than one step to provide the right chemistry utilising a range of processing technologies.

These steps may include: -

  • Fermentation processes
  • Recombinant DNA
  • Isolation and recovery from natural sources
  • A combination of the above-mentioned processes

Schematic Industries are an experienced supplier to the Bulk Drug industry, offering a wide range of world-class processing equipment, technologies and solutions that meet and exceed cGMP and cGAMP standards.

A key part of API manufacturing includes the use of barrier isolators with Schematic have world class expertise.

schematic anfd and barrier isolator lr

Typical API processes where barrier isolators are used include: -

  • Sampling and dispensing
  • Reactor charging
  • Filtration and drying
  • ANFD discharge
  • Centrifuge processing
  • Milling and sifting.

As with the use of all Barrier Isolators key benefits include: -

  • Stable and accurate results
  • Clear visibility during operation and cleaning
  • Operator safety - fully interlocked air-locks, doors and visors
    • This is with a rigid isolator
  • Uncontaminated process media
  • cGAMP - Alarms and safety measures in case of breach
  • Automated Operation - reduced operator error likelihood
    • This is with a rigid isolator

The Standard Group can provide the isolator which integrates with 3rd party machines or the Group can supply a full turnkey solution.