Displaying 26–50 of 101 results for Automation & Control

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Has the Digital Dashboard Finally Arrived?

(Whitepaper)

Advances in IT have made it easier than ever to develop dashboards that take supply chain data, in the form that’s needed, to those who need it most, whether they’re in production/operations or sales and marketing. Edge CSO Prest describes challenges and how to prevent data overload.

Development and Validation of a Corona CAD Method for Simultaneous ...

(Whitepaper)

Rigorous validation of an analytical method utilizing the Corona CAD for measuring major components and impurities in a peptide/lipid drug product formulation is presented. The Corona CAD met or exceeded specification requirements (precision, ruggedness, LOQ, etc.). Implementation resulted in ...

Satisfying GMP with Handheld Near-Infrared Analyzers in the Pharmaceutical ...

(Whitepaper)

Identification and qualification of incoming pharmaceutical raw materials as well as properties of finished forms can be rapidly determined. Handheld near-infrared analyzers significantly enhance workflow and productivity.

Particle Counting in Injectable Solutions

(Whitepaper)

This paper, by Particle Measuring Systems, in its third revision, discusses the requirements laid out by US (USP), European (EP), and Japanese (JP) Pharmacopoeia standards and includes the most recent USP 788 (April 2007), EP 5.1 and JP 15 release information. These standards demand that ...

Achieving Optimal Particle Size Distribution in Inhalation Therapy

(Whitepaper)

Obtaining consistent, appropriate particle size for certain inhaled drugs has been a troublesome task. Pharmaceutical companies are currently developing methods for producing aerosolized formulations containing uniform, optimally sized particles.

Breakthrough Data Recovery for IBM AIX Environments

(Whitepaper)

Downtime and data loss pose intolerable risks to every business today. From IT departments to the Board Room, managers have seen the importance of business uptime and data protection to continued success, productivity and profitability. This white paper provides a road map to the most effective ...

Understanding Chemometrics for Pharmaceutical Analysis

(Whitepaper)

Using chemometric algorithms, modern computer technologies and rapid spectroscopic analysis, provides the basis for the modern-day development of methods of chemical analysis with the best rewards.

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(Whitepaper)

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There Is No Execution Without Integration

(Whitepaper)

In the many fast paced, low-margin, environments that make up the manufacturing industry it is crucial that manufacturers do not adopt technology for technology’s sake. This benchmark report by the Aberdeen Group is a roadmap for reducing overall manufacturing costs through the utilization of ...

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 ...

Using NIR to Monitor Lubricant Uniformity in a Granule Blend

(Whitepaper)

Researchers from Aspen Pharmacare and Nelson Mandela Metropolitan University, South Africa, have developed a method to monitor blending, in real time, by monitoring the change in absorbance of both granule and magnesium stearate lubricant. Krishel Naicker, Gareth Kilian and Johan Olivier describe...

Multivariate Calibration: A Science-Based Method

(Whitepaper)

A new method for multivariate calibration is less costly to implement than standard PLS or PCR methods, and eliminates the need to introduce additional variability into an otherwise stable process. It also allows specific responses to be proven from first principles. Developer Ralf Marbach, from ...

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.

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 ...

New IR Calibration Technique Curbs Costs

(Whitepaper)

The standard industry practice of "statistical" calibration to achieve optical measurements is inefficient whenever a priori physical knowledge about the spectral signal and/or noise is available, argues Prof. Ralf Marbach of the Technical Research Center of Finland. In this white paper, Marbach ...

Raman Microscopy: An Essential Aid in Characterizing Drug Delivery Products

(Whitepaper)

Raman microscopy provides information about molecular organization and crystalline order at the resolution of optical microscopy at the sub-micron scale, and is being used to characterize drug delivery materials. This white paper by Horiba Jobin Yvon discusses the mapping of creams, timed-release...

Assessment of Risk Factors in Container-Closure Systems

(Whitepaper)

This paper looks at applying Process Analytical Technologies to the lyophilization process to mitigate risk factors that could lead to producing a poor product. Dr. Jennings argues that risk can be lowered by increasing the number of samples, thereby raising the confidence level and reducing the ...

IT and Data Security: Deloitte Assesses Pharma's Readiness

(Whitepaper)

Deloitte Touche Tohmatsu (DTT) surveyed a global representation of leading life sciences executives to determine the security issues facing the industry. The resulting study presents industry trends, security considerations that go beyond the realm of IT, and issues such as business continuity ...

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 ...

Dealing with Disparity in On-line and Off-line pH Measurements

(Whitepaper)

Genentech found pH drift in its on-line measurements for a cell culture process, and continues to investigate its cause. (This information was originally presented at IFPAC 2006.)

Case Study: Hungarian Pharma Co. Revamps Digital Plant Architecture

(Whitepaper)

When Gedeon Richter Ltd. set out to automate the tank farm at its main manufacturing facility, the company sought out a vendor that offered not only process knowledge, but also compliance and validation awareness and ongoing performance assurance.

Process Modeling and Control Challenges in the Pharmaceutical Industry

(Whitepaper)

In this 2003 presentation made at a conference held by the University of Texas, Phil Dell'Orco, GSK's Leader for Process Safety and Design, summarized the challenges facing engineers as they work to improve control of pharmaceutical processes in an industry still dominated by chemists.

NIR and Imaging: Basic Principles and Pharmaceutical Applications

(Whitepaper)

This article by Gabriele Reich at the University of Heidelberg's Institute for Pharmaceutical and Molecular Biology examines the basics of NIR spectroscopy.

Best Practices for Materials Handling for Primary and Secondary Pharmaceuticals

(Whitepaper)

This 8-page paper by GEA Pharma Systems provides a timeless summary of specifications and selection criteria, with regard to materials handling and containment.

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.

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