One-Pot Processing And The Benefits For Granulation - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

One-Pot Processing And The Benefits For Granulation


Pharmaceutical Technology Europe
Volume 23, Issue 3


Griet Van Vaerenbergh
One-pot processing is a term that includes any technology that combines different unit operations of a pharmaceutical production process into one machine. In most cases, however, a onepot processor refers to a high shear mixer–granulator that is also equipped with drying technologies. Thus, onepot processing is the production of pharmaceutical granules using a wet granulation process in which dry mixing, liquid addition, wet granulation, drying and sizing of the granules is all performed in one machine.

The benefits of this type of processing are:

  • By integrating granulating and drying capabilities into a single unit, capital investment in equipment and GMP floor space is lower compared with other alternatives.
  • The number of material handling steps is decreased. Consequently, the total processing time is shorter while maintaining a high yield and keeping production support to a minimum. At the same time, the number of required operators is also reduced.
  • Environmental variables, such as humidity, are eliminated from the manufacturing process, which may offer advantages for processing moisture-sensitive formulations.
  • Requirements for solvent recovery systems are lower compared with fluid bed dryers.
  • Reaching a high level of containment is easy by application of the correct measures at in and outlet valves.
  • A single pot can be changed over in less than 2 hours, which makes it a very attractive technology if a large number of different products demanding a high number of product changeovers has to be produced.

Single pot processing has always been a niche technology in the pharma industry, but interest has increased in recent years because of the advantages it offers for producing highly potent compounds, such as oncology medicines and hormones. The concept of a onepot processor in itself already ensures contained processing. Because all unit operations are combined into one machine, the product is completely contained from charging the raw materials up to discharging the dry granulate ready for compression. No product transfers during the process are required, thus drastically reducing the exposure risk. By applying the correct containment measures to loading and discharge valves, a high level of containment is easily achieved.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
8%
All of the above.
46%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
Source: Pharmaceutical Technology Europe,
Click here