Process and Automation

Process analytical technology (PAT) is being successfully used to improve understanding and optimize pharmaceutical unit operations, but greater value can be obtained by integrating PAT with overall process control of a continuous manufacturing system. Pharmaceutical Technology spoke with Ivo Backx, manager of business and project development for the pharmaceutical industry at Siemens Industry Automation Division, to gain insight on the issues involved.

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

QbD paradigm advances process understanding in development and manufacturing.

New product reviews for March 2013, featuring automation, IT, and process control systems.

New product reviews for December 2012.

In this paper, the authors review the various analytical methods that can enable use of PAT.

Real-time experimentation may offer continuous process improvement.

Industry experts share perspectives on analytical instrumentation, methods, and data analysis.

The International Society of Automation’s (ISA’s) 7th Marketing and Sales Summit, held Aug. 15–17, 2012 in Austin, Texas, was themed “New Rules of Customer Engagement: Riding the Winds of Change”, and emphasized the need to adapt to the changing needs, expectations, and behaviors of marketplace decision makers, according to an Aug. 27, 2012 press release.

Industry experts share their insight on solid-dosage and sterile manufacturing.

Readers point to quality by design as having a significant influence on manufacturing and drug development during the past decade.

A look back at key nanoformulation advances and what lies ahead for nanoparticle-based drug-delivery systems.

Industry experts share perspectives on analytical instrumentation, methods, and data analysis.

The authors provide an overview of the new ISPE Guide Series on Product Quality Lifecycle Implementation and how the guides can be used in a complementary way with existing guidance from FDA and the International Conference on Harmonization.

The authors describe the benefits of nuclear magnetic resonance (NMR) compared with traditional monitoring techniques. They also discuss how NMR reaction monitoring provides a new process analytical technology tool for industry.

Industry buy-in is increasing as pharma companies proceed with select projects and research.

A perspective from Pfizer on the lessons from small-molecule manufacturing that can be applied to biomanufacturing.

Quality management requires more effort in a complex supply chain.

Pharmaceutical Technology's annual survey on equipment and machinery reveals the spending levels and type of spending made in 2010 and planned for 2011.

Industry and regulatory experts discuss the challenges and benefits of implementing real time release testing in a pharmaceutical manufacturing environment.

A look at MVI's malaria work in developing countries.

The authors describe the operational requirements and design of a process-ready PAT-based IBD system.

Leading experts share insight on the current and future direction of process analytical technology. This article contains bonus online material.

The authors describe the implementation of an on-line particle-size analyzer on an active pharmaceutical ingredient milling operation at a commercial site.

The author discusses control strategies via near infrared instrumentation for continuous mixing, granulation, drying, and extrusion with a more focused detail on mixing.

Robotic systems provide flexibility and efficiency (and they're not as difficult to use as you think). This article contains bonus online-exclusive material.

The author provides a review of PAT and tools such as near infrared analysis that may facilitate the use of PAT in the biopharmaceutical sector.

This case study describes the implementation of process analytical technology on the cultivation process step of a whole-cell vaccine against whooping cough disease.

The authors review the role of automation in aseptic processing and describe their experience in implementing advanced technologies, including the use of isolators and robotics.

The role of automation suppliers is transforming to meet the pharma industry's demand for change.