Pharmaceutical Technology Europe - June 2010 - (Page 5)

Granulation: evolving slowly but surely Granulation is the most crucial step in the manufacture of solid dosage forms because it provides the main physical modification to the product bulk that affects the rest of the production downstream and, of course, the characteristics of the final form. Because it is such a critical manufacturing step, pharma companies seldom take any risk of technology change, especially for existing proven products, even when there may be opportunities for process improvement. One reason for this hesitation is regulatory uncertainty, which has resulted from the perception that the regulatory system is rigid and unfavourable to the implementation of innovative systems; for example, several manufacturing procedures, including granulation, are often treated as static procedures and process changes are managed through regulatory submissions. Nevertheless, pharma manufacturing has continued to gradually evolve with increasing interest in science and engineering principles. The most recent innovations concerning granulation technologies do not directly involve granulation principles; for instance, a significant trend in the industry relates to PAT and Quality by Design. Significant innovation in process control has been brought about by introducing the latest generation of sensors (NIR, FRBM, acoustic detectors, etc.) for better process understanding and the detection of process end-point to comply with the latest regulatory guidelines. Meanwhile, with regards to safety and toxicity concerns, more attention has been paid to process containment to minimise operational exposure level and cross contamination by rationalising the room layout or introducing new product transfer systems, which can achieve OEB 5 when working in containment. costs, while indirect costs come from out-of-specification products and set-up activities. According to Benson and McCabe, pharmaceutical companies lose approximately $90 billion/year worldwide because they are not able to achieve “world class” production efficiencies. In the future, continuous manufacturing will probably be introduced for new products; however, batch manufacturing will remain for existing products, but will have a greater focus on process understanding and control to implement quality by design. PTE Based on a contribution by Guia Bertuzzi, Granulation Product Manager at IMA ACTIVE. To read the full version of this article, go to www.pharmtech.com/bertuzzi www.imaactive.com Guia Bertuzzi, IMA ACTIVE Additionally, more sophisticated clean in place devices, such as self-cleaning stainless steel filters for fluid bed and self-cleaning sampling devices, have helped reduce cleaning time and improve cleaning reproducibility. Future needs The pharma industry puts high pressure on equipment manufacturers to reduce manufacturing costs (both directly and indirectly) and time to market. Direct costs are referred to as equipment management or operating 1 CONTENTS 7 CONTINUOUS PROCESSES 3 CHANGING TRENDS 8 COATING CHALLENGES 4 EQUIPMENT PROBLEMS 10 CODING TECHNOLOGIES 5 GRANULATION 12 TOP TECHNOLOGIES http://www.pharmtech.com/bertuzzi http://www.imaactive.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - June 2010

Pharmaceutical Technology Europe - June 2010
Contents
Find Out What PTE Readers Feel Are the Most Common Problems Encountered with Their Tabletting Equipment.
Tablet Compression: Changing Trends, More Demands
Tabletting Equipment: Common Problems and How to Avoid Them
Granulation: Evolving Slowly But Surely
Drying: Moving from Batch to Continuous Processes
Challenges in Coating
Flexible Blending
Coding Technologies: Breaking Down the Barriers
Inspection Technologies Update
Twelve Latest Technologies Showcased

Pharmaceutical Technology Europe - June 2010