Displaying 1–25 of 40 results for PAT

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Pharmaceutical Packaging Trends eBook

(Whitepaper)

Pharmaceutical packaging plays a critical role in ensuring the efficient distribution and safe consumption of the world’s drug supply.

White Paper: Determination of Moisture in a Protein Sample Using a Portable ...

(Whitepaper)

This paper reviews an alternate method for rapid determination of the moisture levels in a closed sample vial -- portable NIR technology.

Implementing PAT and QbD? Real-time Particle Size Measurement for the ...

(Whitepaper)

As the pharmaceutical industry implements PAT and QbD, their symbiotic nature becomes increasingly obvious. Both are catalysts towards the longer term goals of continuous operation and real-time release - the realization of a transformed way of working. This article reviews changing practice ...

QbD and Detecting Crystal Polymorphs

(Whitepaper)

No longer just a fingerprinting method, X-Ray Powder Diffraction is becoming a user-friendly PAT tool. This white paper discusses how accessible XRPD systems address the needs of today's pharmaceutical industry, which requires a multi-disciplinary approach to pharmaceutical product design.

PAT application: At-line TOC for Cleaning Validation and Product Changeover

(Whitepaper)

The Food and Drug Administration's 2004 PAT guidance document for improving pharmaceutical manufacturing efficiency and quality discusses using at-line methods for data collection. This application note from GE Analytical Instruments demonstrates the applicability and capability of at-line total ...

PAT and TOC Analysis With an Onboard Automated Standards Introduction System ...

(Whitepaper)

This paper describes the use of an on-board automated standards introduction system (OASIS) that is used to run verification standards and system suitability tests in order to ensure the reliability of the TOC results. The speed and efficiency gained by use of this automated system means that the...

Using Model Predictive Control-based PAT to Optimize Distillation

(Whitepaper)

This application note describes how advanced automation, using Emerson's Delta V system, is improving process understanding and product quality at Baxter's anesthetics facility in Guayama, Puerto Rico.

Achieving Manufacturing Process Excellence with Quality by Design, Design ...

(Whitepaper)

Process improvement and Quality by Design become practical realities only when the barriers to easily accessing and working with all the process data together are removed, and the team can spend its time instead on productive science-based collaboration. This is the best way to undertake the ...

Online Reaction Monitoring of Inprocess Manufacturing Samples by UPLC

(Whitepaper)

Process Analytical Technology (PAT) is a critical component in manufacturing, relied upon to ensure product quality and improve process yields. In this white paper, Waters Corp. discusses the use of novel Waters technology for online reaction monitoring of inprocess manufacturing samples, which ...

Controlling the API Drying Process: Comparing NIR, Raman and Teraherz

(Whitepaper)

This month in Helsinki, Karin Kogermann presented results of four years of research into solid state transformations, comparing the effectiveness of NIR, Raman and Teraherz pulsed methods. Included on p. 11-13 is a useful table comparing the strengths and weaknesses of each technique. Work ...

Podcast: FDA's Dr. Janet Woodcock on New Directions for FDA in 2007

(Whitepaper)

In February, 2007, after she was named Chief Medical Officer of FDA, Dr. Janet Woodcock spoke about how she plans to bring new science and an atmosphere of open debate to the Agency, and how the concepts of manufacturing science can reshape R&D and clinical work, and, ultimately, make medicine ...

PAT Needs and Applications in the Bioprocess Industry

(Whitepaper)

In this comprehensive report, the authors examine what PAT means in practice for the biotechnological manufacture of pharmaceuticals. They analyze regulatory issues, monitoring methods and available technologies, and compare their findings against the needs for monitoring in bioprocess-based ...

From Procedural to Risk-Based Compliance and Enforcement

(Whitepaper)

In this paper, ARC Advisory Group analyst John Blanchard outlines the steps required for moving from the old to the new model, and what they mean for pharma manufacturers and the FDA.

Benchmarking Report on Pharmaceutical Manufacturing

(Whitepaper)

This report, the result of extensive research by professors from Washington University and Georgetown University, examines cycle times, quality assurance, use of IT, employee empowerment and other factors at 42 drug manufacturing facilities to provide benchmarks.

Kick–Starting PAT to Achieve Quality by Design in cGMP Bioprocessing

(Whitepaper)

Since 2002, the FDA has promoted a continuous, process-centric approach to validation vs. the prior product–centric one. Yet, many pharma and biopharma companies have failed to incorporate that approach into their strategic plan. This white paper explains the new distinctions and what they mean ...

A Science-based Performance Comparison of On-line TOC Analyzers

(Whitepaper)

As more and more pharmaceutical companies switch from laboratory TOC analysis to PAT-friendly, on-line, real-time release systems, decision makers need to know the critical parameters for success. This white paper from GE Analytical Instruments examines the performance capabilities of various ...

A Science-based Performance Comparison of On-line TOC Analyzers

(Whitepaper)

A method validation approach is used to evaluate four commercially available on-line TOC methodologies used for pharmaceutical real-time water release or cleaning validation applications. This white paper provides a technical explanation of how each TOC method works and percent recovery results ...

Aligning PAT, Validation and Post-Validation Process Improvement

(Whitepaper)

The drug industry’s manufacturing techniques have been criticized as “far behind those of potato chip and laundry soap makers.” This paper’s authors, from Tunnell Consulting, lay out a plan for implementing process analytical technology, improving process understanding and reducing the cost of ...

Using PAT for Crystallization and Drying

(Whitepaper)

In this article, Zhihong Ge and colleagues from Merck Research Labs discuss how they used PAT to monitor asymmetrical hydrogenation, crystallization and API drying.

PAT and the Need for High-Availability Platforms

(Whitepaper)

Continuing advances in biomedical technology, new and emerging compliance requirements, sociopolitical pressures and global competition are driving new mission-critical systems into pharmaceutical manufacturing. This paper looks at the hardware and system implications of the new regulatory ...

The Drug Industry at a Crossroad: PAT's Role

(Whitepaper)

In this 6-page PDF document, author Efraim Shek asserts that PAT is part of a new paradigm whose time has come, and suggests how PAT can become more the rule than the exception.

Using PAT to Optimize Cell Culture for Monoclonal Antibody Development

(Whitepaper)

Ache Stokelman and colleagues on Amgen’s Global Process Science Team outline how they used BioProcessors Corp.’s SimCell platform to improve results.

Aseptic PAT and Particle Monitoring — from Snapshots to Continuous Feedback

(Whitepaper)

Particle monitoring is critical for maintaining aseptic conditions, but portable counters won’t help develop trending data. In this white paper, Mark Hallworth, pharmaceutical manager for Particle Measuring Systems, discusses continuous monitoring methods, how they’re evolving, and why they’re ...

PAT: The Value of Better Control

(Whitepaper)

Process Analytic Technology (PAT) provides pharmaceutical manufacturers with an opportunity to use the latest Advanced Process Control (APC) tools to better understand and control process variability. Learn the keys to successful PAT projects and how you can use them to turn data into knowledge, ...

PAT and Pharma Competence

(Whitepaper)

This Guide to Process Analytical Technology analyzes the industry’s needs and discusses Siemens' multidisciplinary approach to meeting them.

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