Pharmaceutical / GMP Extrusion

Extrusioneering International is the only independent consulting organization specializing in pharmaceutical applications using twin-screw extrusion technology. We have been active in melt extrusion technology since 1995, providing clients around the world with professional services for what has become an emerging drug delivery platform.

Validation Services

Extrusioneering International is uniquely qualified to develop and execute validation documents for twin-screw extrusion equipment. To-date, we have qualified more than twenty (20) twin-screw extrusion lines around the world in both manufacturing sites and R&D environments:

  • Development of User Requirements Specification
  • Vendor Selection
  • Equipment Specification
  • Review & Witnessing of FAT's, Commissioning
  • Development & Execution of Installation Qualification (IQ) Protocols
  • Development & Execution of Operational Qualification (OQ) Protocols
  • Development & Execution of Process Qualification (PQ) Protocols
  • Development of Standard Operating Procedures (SOP's) for Operation, Cleaning and Preventive Maintenance
  • Training for SOP's

Our 25 years experience with twin-screw machinery (as well as auxiliary support equipment) and attention to detail enable us to develop qualification documents which are accurate (i.e. no deviations) and in less time than other validation services providers (who have never seen an extruder before).

 

Pharmaceutical Extrusion Seminars

Training seminars covering twin screw extrusion technology specifically for pharmaceutical applications can be scheduled at your plant site and at your convenience. These seminars provide an overview of extrusion technology in traditional polymer processing with sufficient technical depth to understand the challenges for melt processing of API's and continuous granulation applications.

Send us an email for information on scheduling an in-house seminar !