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Automation, Instrumentation, Controls

How Manufacturing Execution Systems Enable PAT
By Camstar Systems Inc.
White paper
Process Analytical Technology (PAT) aims to increase the likelihood of defect-free pharmaceuticals, and this white paper from Camstar Systems Inc. discusses how a manufacturing execution system (MES) can align multiple business initiatives.

The state of PAT in the pharmaceutical industry
By Pavilion Technologies
White paper
This study by Pavilion Technologies asked major manufacturers to share details and insights regarding process analytical technology (PAT).

Pharma competence: Your process analytical technology guide
By Siemens Corp.
White paper
This white paper by Siemens AG discusses how pharmaceutical companies can achieve manufacturing goals using process analytical technology (PAT) in a variety of ways, including determining how to minimize off-spec products and maximize product yields; creating consistent quality and earlier identification of unsuccessful batches and 24-hour process control.

Process analytical technology: A framework for innovative pharmaceutical ...
By Thermo Electron Corp.
White paper
In this white paper, Thermo Electron Corp. provides its perspective on the impact of process analytical technology (PAT) on pharmaceutical manufacturers and their vendors.

Monitoring a process critical control parameter—crystallization
By Bruker Optics Inc.
White paper
This white paper by Bruker Optics Inc. explains the optic-based process Fourier transform near infrared (FT-NIR) spectrometer used to monitor crystallization.

Process analytical technology approaches to risk reduction through quality by...
By SSCI Inc.
White paper
This white paper by SSCI Inc. explains process analytical approaches to risk reduction through quality by design.

Clinical Trials

A Technological Solution for Combating Counterfeit Drugs
By PANalytical Inc.
White paper
This white paper examines the issue of counterfeit drugs, reviewing the various types produced and the nature and range of the damage they cause. The report then focuses on analytical methods for tackling the problem, in particular the use of X-ray powder diffraction (XRPD).

The MET ONE 7000
By Hach Ultra
Product collateral
The MET ONE 7000 remote airborne particle counters provide the most accurate continuous monitoring for the aseptic and sterile pharmaceutical production environments.

Production of Polymer Nanosuspensions
By Microfluidics Corp.
White paper
<P>This article showcases polymer nanosuspensions in the range of 50-500 nm that were prepared with two different polymers, using both techniques. Furthermore, these tests indicate that an API was successfully encapsulated within the nanoparticles.</P>

Achieving Ultra Fast Liquid Chromatography
By Shimadzu Scientific Instruments
White paper
The demand for increased efficiency and speed in pharmaceutical analysis extends through drug discovery and development to clinical screening and trials. The need to meet these throughput requirements without compromising the data has highlighted the important technical challenge of providing faster separation in HPLC.

Best Practices for Raw Material Inspection
By Ahura Scientific, Inc.
White paper
Ahura Scientific collaborated with an independent research organization that specializes in return on investment (ROI) and cost-benefit analysis to perform an objective study of the financial returns generated by the use of TruScan.

Determination of Fe in Milk Powder
By PANalytical Inc.
Application note
Milk is a source of essential nutrients for humans, therefore the elemental analysis of milk powder is very important. Of all the metals, iron is one of the most known as a nutrient. Measurements in this study were performed using the MiniPal 2 benchtop EDXRF spectrometer.

Compliance Services

Optimizing enterprise information security compliance
By VeriSign Inc.
White paper
This white paper by VeriSign explains information-security compliance and auditing among companies that must contend not only with internal, federal and industry-specific regulations and policies, but also with security practices and requirements of their networked partners, suppliers and customers.

Advanced standard operating procedures
By Rockwell Automation Inc.
Application note
In this application note, Rockwell Automation Inc. describes how its compliance services support and lead initiatives to help optimize, enhance or substitute standard operating procedures to optimally use risk-based concepts and to streamline SOP system for efficiency.

Compliance challenges with enterprise application integration
By Clarkston Consulting
White paper
This white paper by Clarkston Consulting describes challenges faced by life sciences companies to meet 21 CFR Part 11 regulations with respect to enterprise application integration.

Validated HPLC columns
By MAC-MOD Analytical Inc.
Application note
In this application note, MAC-MOD Analytical Inc. describes a method of validating high-performance liquid chromatography (HPLC) columns that assures constant column performance over the lifetime of an analytical method.

Executive briefing toward an approach to intellectual property
By Auto-ID Laboratories
White paper
This white paper by Auto-ID Laboratories discusses intellectual property with respect to free markets, corporate competitive advantage and rights of patent holders.

Compliance and mobile computing
By Intermec Technologies Corp.
White paper
This white paper by Intermec Technologies describes compliance and mobile computing concepts, including steps to secure mobile applications, best practices of mobile computing, and automatic identification and data capture (AIDC) to store securely sensitive customer data.

Consulting Services

Pharma 2010: Silicon reality
By IBM Corp.
White paper
This white paper by IBM Business Consulting Services identifies the seven key technologies that IBM believes will drive innovation in the life sciences over the next decade.

Pharma 2010: The Threshold of Innovation
By IBM Corp.
White paper
This white paper is part of IBM Business Consulting Services' on-going commitment to forward-looking industry and business points of view, and their aim to help companies and industries transform futures.

384-well format ethanol precipitation method
By GE Healthcare Bio-Sciences
Application note
This application note by GE Healthcare Bio-Sciences, formerly Amersham Biosciences, describes the conditions and process of ethanol precipitation for the removal of excess dye terminators performed in a 384-well format.

Steris VHP 100 Biodecontamination Systems
By Steris Corp.
Product collateral
<SPAN>Steris biodecontamination applications feature vaporized hydrogen peroxide technology and each application offer biological safety cabinets, small isolators, glove boxes, incubators, and small pass-through chambers.</SPAN>

Time-of-flight solutions in pharmaceutical development
By Agilent Technologies
Application note
In this application note, Agilent Technologies explores the collection of examples and applications based on the Agilent liquid chromatography/mass-selective detector (LC/MSD) time-of-flight mass spectrometer and focuses on the power of accurate mass in both qualitative and quantitative applications.

Methodologies for integrating auto-ID data with existing manufacturing BIS
By Auto-ID Laboratories
White paper
This white paper by Auto-ID Laboratories provides background on manufacturing business information systems (BISs) and provides guidelines to automatic identification-provided information into these systems.

Educational

Creating a Six Sigma culture
By CLG
White paper
How do you help people embrace Six Sigma? According to this white paper from CLG, the key is to treat your efforts as a cultural change within your organization.

Compliance challenges with enterprise application integration
By Clarkston Consulting
White paper
This white paper by Clarkston Consulting describes challenges faced by life sciences companies to meet 21 CFR Part 11 regulations with respect to enterprise application integration.

The state of e-pedigree laws
By SupplyScape Inc.
White paper
This white paper from SupplyScape Inc. offers an overview of the U.S. states that require certified drug authentication.

Electronic submissions in compliance with regulatory requirements for the ...
By Kyberpass Corp.
White paper
This white paper by Kyberpass Corp. describes the technology behind end-to-end electronic submission of new drug applications and some options for electronic submission tools.

Global approach to safety pharmacology
By MDS Pharma Services
White paper
This white paper by MDS Pharma Services is an interview with Dr. Stephane Milano, senior scientist of safety pharmacology at MDS, on taking a global approach to safety pharmacology.

Book rebuff
White paper
This white paper by Pharmaceutical Research and Management Association identifies major claims in the pharmaceutical industry and provides accurate information and dispels errors and omissions.

Educational Services

Compliance challenges with enterprise application integration
By Clarkston Consulting
White paper
This white paper by Clarkston Consulting describes challenges faced by life sciences companies to meet 21 CFR Part 11 regulations with respect to enterprise application integration.

The state of e-pedigree laws
By SupplyScape Inc.
White paper
This white paper from SupplyScape Inc. offers an overview of the U.S. states that require certified drug authentication.

Electronic submissions in compliance with regulatory requirements for the ...
By Kyberpass Corp.
White paper
This white paper by Kyberpass Corp. describes the technology behind end-to-end electronic submission of new drug applications and some options for electronic submission tools.

Global approach to safety pharmacology
By MDS Pharma Services
White paper
This white paper by MDS Pharma Services is an interview with Dr. Stephane Milano, senior scientist of safety pharmacology at MDS, on taking a global approach to safety pharmacology.

Book rebuff
White paper
This white paper by Pharmaceutical Research and Management Association identifies major claims in the pharmaceutical industry and provides accurate information and dispels errors and omissions.

Economic benefits of EPC in pharmaceuticals
By Auto-ID Laboratories
White paper
This white paper by the Auto-ID Center offers information on applying electronic product code (EPC) technology.

Engineering

PAT and TOC Analysis With an Onboard Automated Standards Introduction System ...
By Hach Ultra
White paper
<P>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. </P>

Engineering and Turnkey Services
Product collateral
<P>The Glatt Engineering and Projects division offers extensive expertise for producing complete, comprehensive solutions for solid products, liquids, or sterile products.</P>

Toyo Engineering Corp. increases operator productivity by 30 percent at ...
By Rockwell Automation Inc.
Case study
In this case study, Rockwell Automation Inc. provides the Propack Data MES solution to Toyo Engineering Corp., leading to reduced production and labor costs, a 30 percent increase in operator productivity and faster time to market.

Micro-space planning and work cell design
By Strategos, Inc.
White paper
This white paper from Strategos, Inc. discusses how micro-space-planning affects supervision, organizational learning, costs, inventory, quality, delivery, flexibility and coordination, as well as many aspects of the firm's cost structure.

Stainless steel primer
By Hurst Corp.
White paper
This white paper from Hurst Corp. goes over the basics of the types of stainless steel and its attributes.

Innovative technology for automated tablet production
By GE Fanuc Automation
Case study
In this case study, GE Fanuc Automation Inc. builds the foundation for a new pharmaceutical plant for Krka NOTOL with a design that incorporates

Enterprise

A Technological Solution for Combating Counterfeit Drugs
By PANalytical Inc.
White paper
This white paper examines the issue of counterfeit drugs, reviewing the various types produced and the nature and range of the damage they cause. The report then focuses on analytical methods for tackling the problem, in particular the use of X-ray powder diffraction (XRPD).

The MET ONE 7000
By Hach Ultra
Product collateral
The MET ONE 7000 remote airborne particle counters provide the most accurate continuous monitoring for the aseptic and sterile pharmaceutical production environments.

Production of Polymer Nanosuspensions
By Microfluidics Corp.
White paper
<P>This article showcases polymer nanosuspensions in the range of 50-500 nm that were prepared with two different polymers, using both techniques. Furthermore, these tests indicate that an API was successfully encapsulated within the nanoparticles.</P>

Achieving Ultra Fast Liquid Chromatography
By Shimadzu Scientific Instruments
White paper
The demand for increased efficiency and speed in pharmaceutical analysis extends through drug discovery and development to clinical screening and trials. The need to meet these throughput requirements without compromising the data has highlighted the important technical challenge of providing faster separation in HPLC.

Best Practices for Raw Material Inspection
By Ahura Scientific, Inc.
White paper
Ahura Scientific collaborated with an independent research organization that specializes in return on investment (ROI) and cost-benefit analysis to perform an objective study of the financial returns generated by the use of TruScan.

Determination of Fe in Milk Powder
By PANalytical Inc.
Application note
Milk is a source of essential nutrients for humans, therefore the elemental analysis of milk powder is very important. Of all the metals, iron is one of the most known as a nutrient. Measurements in this study were performed using the MiniPal 2 benchtop EDXRF spectrometer.

Fabrication

Field Erected Fabrication
By A&B Process Systems Corp.
Product collateral
A&B has developed the capability to fabricate and install processing equipment at the customer’s site, providing the same high quality workmanship and timely completion of the project.

Polished stainless steel tubing and piping
By A&B Process Systems Corp.
White paper
This white paper by A&B Process Systems Corp. explains the fabrication of stainless steel tubing and piping industry standards to which they are fabricated.

Project Management and Installation Services
By A&B Process Systems Corp.
Product collateral
In addition to the design, fabrication and building of stainless steel processing equipment, A&B Process Systems is prepared to demolish existing equipment and to ready the site for the new equipment.

A guide to stainless steel process piping and process piping installation
By A&B Process Systems Corp.
White paper
This white paper by A&B Process Systems Corp. is a guide to stainless steel process piping and process piping installation.

Modular-Skidded Systems
By A&B Process Systems Corp.
Product collateral
A&B offers modular/skidded systems for installation with fabrication and processing systems.

The melt system: Controlling a change of state for the processing industries
By A&B Process Systems Corp.
White paper
This white paper by A&B Process Systems Corp. explains the melt system, which typically includes a stainless steel tank, a melt grate, agitators, pumps, heat transfer panels and an external heat exchange unit, interconnected by stainless steel piping.

Facilities

Facility monitoring systems and 21 CFR part 11 compliance
By Lighthouse Worldwide Solutions
Application note
In this application note, Lighthouse Worldwide Solutions describes the benefits of facility monitoring systems to establish compliance with 21 CFR Part 11 regulations.

Security planning and design for 21st century pharmaceutical facilities
White paper
This white paper by Kling Inc. describes elements of security planning and design for pharmaceutical facilities.

Evaluating and specifying ergonomic matting in pharmaceutical processing ...
By Ergomat
White paper
This white paper by Ergomat outlines the fundamental questions pharmaceutical professionals should ask to outfit their work area, laboratory or cleanroom with the most appropriate floor matting.

Temperature mapping and monitoring: Quality control tools for pharmaceutical ...
By Johnson Controls Inc.
White paper
This white paper from Johnson Controls discusses the state of storage facilities for pharma and biomedical companies and how to optimize temperature control in warehousing spaces for temperature- and humidity-sensitive products.

TD-12-FM and TD-14-FM tear drop air foil luminaries
By Isolation Systems Inc.
Product collateral
<P>Isolation Systems TD-12-FM and TD-14-FM tear drop air foil luminaries are an integral part of facility and cleanroom efficiency. </P>

ABB controls modernized Vitamin C facility at Roche Products
By ABB Inc.
Case study
In this case study, ABB's Advant OCS (open control system) technology automated process equipment being installed at Roche Products' dairy facility, one of the most important vitamin manufacturing facilities in Europe.

Laboratory

Comparison of TOC Analyzers and Sensors for Pharmaceutical TOC Applications
By GE Analytical Instruments
Application note
In 2006, Jon S. Kauffman, PhD., Lancaster Laboratories, published results from a study on the recovery of organic compounds likely to be present in pharmaceutical water systems using on-line TOC analyzers designed for pharmaceutical use. A new study repeats the same injections, but adds the new CheckPoint TOC Sensor from GE Analytical Instruments.

Laboratory Glassware Flasks
By Wilmad-Labglass
Product collateral
Wilmad-LabGlass offers an inventory of heavy walled and standard flasks.

Roemmers Laboratories continues to lead the pharmaceutical industry in Latin ...
By Rockwell Automation Inc.
Case study
In this case study, Rockwell Automation Inc. provides Roemmers Laboratories with Propack Data MES for production programming, monitoring and production process functions, and integrates the system with its SCADA process control systems, SAP management system and SGA automatic storage system.

Fundamentals of combustible gas detection
By General Monitors Inc.
White paper
This handbook from General Monitors Inc. is a guide to the characteristics of combustible gases and applicable detection technologies including characteristics, applications and classifications.

Streamline the Chromatographic Method Validation Process Using Empower 2 ...
By Waters Laboratory Informatics
White paper
This white paper by Waters Laboratory Informatics discussed how Empower 2 Method Validation Manager can reduce the time and costs required to perform chromatographic method validation by as much as 80%.

Covance Virtual Central Laboratory Services
By Covance Inc.
Product collateral
Covance Virtual Central Laboratory Services provides global clinical trial lab data from local and regional laboratories.

Manufacturing

A Technological Solution for Combating Counterfeit Drugs
By PANalytical Inc.
White paper
This white paper examines the issue of counterfeit drugs, reviewing the various types produced and the nature and range of the damage they cause. The report then focuses on analytical methods for tackling the problem, in particular the use of X-ray powder diffraction (XRPD).

The MET ONE 7000
By Hach Ultra
Product collateral
The MET ONE 7000 remote airborne particle counters provide the most accurate continuous monitoring for the aseptic and sterile pharmaceutical production environments.

Production of Polymer Nanosuspensions
By Microfluidics Corp.
White paper
<P>This article showcases polymer nanosuspensions in the range of 50-500 nm that were prepared with two different polymers, using both techniques. Furthermore, these tests indicate that an API was successfully encapsulated within the nanoparticles.</P>

Achieving Ultra Fast Liquid Chromatography
By Shimadzu Scientific Instruments
White paper
The demand for increased efficiency and speed in pharmaceutical analysis extends through drug discovery and development to clinical screening and trials. The need to meet these throughput requirements without compromising the data has highlighted the important technical challenge of providing faster separation in HPLC.

Best Practices for Raw Material Inspection
By Ahura Scientific, Inc.
White paper
Ahura Scientific collaborated with an independent research organization that specializes in return on investment (ROI) and cost-benefit analysis to perform an objective study of the financial returns generated by the use of TruScan.

Determination of Fe in Milk Powder
By PANalytical Inc.
Application note
Milk is a source of essential nutrients for humans, therefore the elemental analysis of milk powder is very important. Of all the metals, iron is one of the most known as a nutrient. Measurements in this study were performed using the MiniPal 2 benchtop EDXRF spectrometer.

Packaging

A Technological Solution for Combating Counterfeit Drugs
By PANalytical Inc.
White paper
This white paper examines the issue of counterfeit drugs, reviewing the various types produced and the nature and range of the damage they cause. The report then focuses on analytical methods for tackling the problem, in particular the use of X-ray powder diffraction (XRPD).

The MET ONE 7000
By Hach Ultra
Product collateral
The MET ONE 7000 remote airborne particle counters provide the most accurate continuous monitoring for the aseptic and sterile pharmaceutical production environments.

Production of Polymer Nanosuspensions
By Microfluidics Corp.
White paper
<P>This article showcases polymer nanosuspensions in the range of 50-500 nm that were prepared with two different polymers, using both techniques. Furthermore, these tests indicate that an API was successfully encapsulated within the nanoparticles.</P>

Achieving Ultra Fast Liquid Chromatography
By Shimadzu Scientific Instruments
White paper
The demand for increased efficiency and speed in pharmaceutical analysis extends through drug discovery and development to clinical screening and trials. The need to meet these throughput requirements without compromising the data has highlighted the important technical challenge of providing faster separation in HPLC.

Best Practices for Raw Material Inspection
By Ahura Scientific, Inc.
White paper
Ahura Scientific collaborated with an independent research organization that specializes in return on investment (ROI) and cost-benefit analysis to perform an objective study of the financial returns generated by the use of TruScan.

Determination of Fe in Milk Powder
By PANalytical Inc.
Application note
Milk is a source of essential nutrients for humans, therefore the elemental analysis of milk powder is very important. Of all the metals, iron is one of the most known as a nutrient. Measurements in this study were performed using the MiniPal 2 benchtop EDXRF spectrometer.

QA/QC, Testing Services

Process analytical technologies and nonviable particle counting
By Particle Measuring Systems
White paper
In this white paper by Particle Measuring Systems, the relationship between process analytical technology (PAT) and particle measurement in a cleanroom situation is discussed.

Understanding particulate contaminants via automated electron beam analysis
By Aspex Corp.
White paper
This white paper by Aspex Corp.demonstrates that analysis of particulate materials by an automated electron-beam instrument is a powerful and practical technique for understanding particle distributions with respect to size, shape and composition.

Simulated moving bed chromatography for preparative separation
By Novasep Inc.
White paper
This white paper by Novasep Inc. provides a basic understanding of moving bed chromatography, discusses the instrumentation used and offers an overview of developing a simulated moving bed method. It also surveys some industrial applications.

Efficient primary structure elucidation of disulfide-bridged peptides
By Applied Biosystems
Application note
In this application note, Applied Biosystems explains how the primary structure determination of disulfide bridged peptides is greatly facilitated using a combination of the Procise cLC 492 sequencing system and the QSTAR pulsar hybrid quadrupole time of flight mass spectrometer.

Measuring Chemokine-Induced Chemotaxis through Actin Polymerization Assays
By Guava Technologies Inc.
Application note
In this application note, Guava Technologies, Inc. explains measuring of Chemokine-induced Chemotaxis through actin polymerization assays.

How Manufacturing Execution Systems Enable PAT
By Camstar Systems Inc.
White paper
Process Analytical Technology (PAT) aims to increase the likelihood of defect-free pharmaceuticals, and this white paper from Camstar Systems Inc. discusses how a manufacturing execution system (MES) can align multiple business initiatives.

Specialty Services

Polymorphy in pharmaceuticals
By Horiba Jobin Yvon
Application note
In this application note, Horiba Jobin Yvon describes how Raman spectroscopy provides qualitative and quantitative information on polymorphy and its advantages over other spectroscopy techniques.

Guide for infrared spectroscopy
By Bruker Optics Inc.
White paper
This white paper by Bruker Optics Inc. serves as a guide for infrared (IR) spectroscopy. It features IR spectroscopy tables with conversion tables of energy and wavelength units and transmittance and absorbance units.

High-resolution off-line liquid monitoring
By Particle Measuring Systems
Application note
In this application note, Particle Measuring Systems describes two LiQuilaz spectrometers that detect particles suspended in liquid between 0.2 and 125.0 microns and configuration settings and software used.

Tailoring resources for the right solution
By Quintiles Transnational Corp.
Case study
In this case study, Quintiles Transnational recruits patients for a pharmaceutical company's study involving a unique transdermal delivery device and reduces the average turnaround time of site reports by 50 percent.

Customer and Quintiles team up for greater speed
By Quintiles Transnational Corp.
White paper
In this case study, Quintiles Transnational meets the requests of a top 10 pharmaceutical company looking to reduce the time to database lock by two months.

Monitoring the water content in heat transfer fluid
By Bruker Optics Inc.
White paper
This white paper by Bruker Optics Inc. describes the process of monitoring the water content in heat transfer fluid.

Supply Chain

A Technological Solution for Combating Counterfeit Drugs
By PANalytical Inc.
White paper
This white paper examines the issue of counterfeit drugs, reviewing the various types produced and the nature and range of the damage they cause. The report then focuses on analytical methods for tackling the problem, in particular the use of X-ray powder diffraction (XRPD).

The MET ONE 7000
By Hach Ultra
Product collateral
The MET ONE 7000 remote airborne particle counters provide the most accurate continuous monitoring for the aseptic and sterile pharmaceutical production environments.

Production of Polymer Nanosuspensions
By Microfluidics Corp.
White paper
<P>This article showcases polymer nanosuspensions in the range of 50-500 nm that were prepared with two different polymers, using both techniques. Furthermore, these tests indicate that an API was successfully encapsulated within the nanoparticles.</P>

Achieving Ultra Fast Liquid Chromatography
By Shimadzu Scientific Instruments
White paper
The demand for increased efficiency and speed in pharmaceutical analysis extends through drug discovery and development to clinical screening and trials. The need to meet these throughput requirements without compromising the data has highlighted the important technical challenge of providing faster separation in HPLC.

Best Practices for Raw Material Inspection
By Ahura Scientific, Inc.
White paper
Ahura Scientific collaborated with an independent research organization that specializes in return on investment (ROI) and cost-benefit analysis to perform an objective study of the financial returns generated by the use of TruScan.

Determination of Fe in Milk Powder
By PANalytical Inc.
Application note
Milk is a source of essential nutrients for humans, therefore the elemental analysis of milk powder is very important. Of all the metals, iron is one of the most known as a nutrient. Measurements in this study were performed using the MiniPal 2 benchtop EDXRF spectrometer.

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