Displaying 26–40 of 40 results for PAT

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A Value First Approach to PAT

(Whitepaper)

Tunnell discuss’s how PAT can add the most value to your organization with simple, but powerful, principles.

NIR-based PAT Replaces HPLC for Bottling

(Whitepaper)

This application note from Uhlmann VisioTec discusses NIR spectroscopy, offering some insights into how it was used to replace HPLC analysis at a pilot-scale pharmaceutical suspension bottling line.

How MES Enables PAT

(Whitepaper)

A Manufacturing Execution System provides a framework for PAT, allowing for enhanced productivity and quality, says Joseph Vinhais, vice president of regulatory compliance at Camstar Systems.

The State of PAT in the Pharmaceutical Industry

(Whitepaper)

Pavilion Technologies’ recent survey of major manufacturers reveals divergent strategies between the U.S. and Europe, and mixed opinions about how broadly PAT should be defined. Quantitative and qualitative data are summarized here.

Raman 101: A Primer for In-Situ PAT

(Whitepaper)

For in-situ PAT, Raman spectroscopy has advantages over Near-IR and Mid-IR. This technical note by Kaiser Optical Systems discusses Raman’s suitability for PAT applications and lists specific application opportunities.

Engineering Standards Advance Pharmaceutical PAT

(Whitepaper)

Manuel Hormaza, CEO of IBS Caribe, discusses process understanding and management, and the engineering standards that promise to bring plug-and-play capabilities to PAT.

Taming the Data Monster: Practical Guidance on Implementing PAT

(Whitepaper)

A new applications document from Automsoft summarizes the IT requirements for PAT, focusing on data management issues.

Optimize Bioreactor Design with PAT

(Whitepaper)

This article outlines how PAT can be used to monitor bioreactors, and how this real-time monitoring was achieved by integrating advanced process control tools into the Simatic PCS 7.

Control Particle Size, Polymorphic Form and Blending

(Whitepaper)

This applications note by the contract research firm SSCI Inc. provides an overview on how PAT can be used in pharmaceutical solids processing.

The Business Case for PAT

(Whitepaper)

Having trouble justifying PAT projects to top management? The business drivers for PAT are compelling, both on the regulatory and on the financial side. This Rockwell Automation white paper discusses how to conduct a "productivity improvement appraisal" and how to handle discovery and analysis ...

Using PAT in Risk-Based Development and CMC

(Whitepaper)

This July presentation by Professor Kenneth R. Morris, Purdue University's Department of Industrial and Physical Pharmacy, discusses the use of PAT in a risk-based approach to drug development and CMC.

Standards for Pharmaceutical Applications of PAT

(Whitepaper)

This presentation by Don Marlowe, FDA Standards Coordinator in the Office of the Commissioner, outlines the ASTM E-55 Committee's efforts in developing PAT standards for pharmaceutical applications.

New Opportunities in Pharmaceutical Manufacturing

(Whitepaper)

This 2001 presentation to FDA's Science Board, helped spark the pharmaceutical manufacturing quality revolution and use of PAT in drug manufacturing. Dr. Raju is head of CAMP, MIT's program on the pharmaceutical industry, and CEO of the consulting firm, Light Pharma.

PAT Answers: FDA's Final Guidance

(Whitepaper)

FDA recently released its final guidance on process analytical technology, “PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance," as part of its broader 21st Century cGMP initiative.

Applying PAT to Crystallization

(Whitepaper)

Crystallization processes pose challenges to manufacturers who seek to apply process analytical technologies (PAT), but progress is being made. This paper, from FDA's Center for Drug Evaluation and Research, discusses the challenges and provides some examples of how they're being addressed.

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