Browse Solutions: Manufacturing


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Analysis and Measurement

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 sample 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>

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.

X'Pert Pro Alpha-1
By PANalytical Inc.
Product collateral
The X'Pert Pro Alpha-1 diffraction system is suitable for solving structures from powder data, searching for polymorphic phases where peak overlap is a hinderance, studying nanomaterial peak profiles to extract crystallite size, dislocation densities and preparing materials for synchrotron beam time.

High Throughput Diffraction
By PANalytical Inc.
Product collateral
PANalytical's X'Pert PRO MPD, equipped with automated sample changer and high speed, high resolution X'Celerator detector can already measure hundreds of full scans every day.

X'Pert PRO MPD: Multi-Purpose X-Ray Diffractometer
By PANalytical Inc.
Product collateral
The X'Pert PRO MPD x-ray powder diffractometer offers a variety of optics, sample stages, changers and detectors allowing the optimal combination of resolution and data collection speed for every sample.

ISO 21501: A Standard Methodology to Optical Particle Counter Calibration and...
By Hach Ultra
White paper
ISO 21501 is a new family of standards describing the instruments and calibration requirements for determining particle size distribution using light interaction methods.

APIs ingredients and chemicals

Chemical Development and API Manufacturing
By Cardinal Health
Product collateral
Cardinal Health offers chemical development services, from preclinical support and process development to active pharmaceutical ingredient (API) manufacturing on a commercial scale.

Less is more in API process development
By EPCOT International
White paper
According to this white paper from EPCOT International Inc., U.S. manufacturers can simplify their processes and lower their costs to make active pharmaceutical ingredients.

Automation and Process Control

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 sample 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>

Geometry Unifies Process Control, Production Control and Alarm Management
By Curvaceous Software Ltd.
White paper
This white paper from Curvaceous Software Ltd. shows how geometric process control (GPC) combines the three key plant applications of process control, production control and alarm management and improves all three.

PAT: Exploring the New Philosophy of the FDA
By Automsoft
White paper
In this white paper, Automsoft details the FDA's move from inspected quality to a system of continuous quality management supported by key technologies, and the importance of information technology in process analytical technology (PAT).

Online Analysis of Tablets Including Content Uniformity
By Bruker Optics Inc.
White paper
In this white paper, Bruker Optics shows how its near-infrared (NIR) spectroscopy products can be used at almost each step of tablet manufacturing in the pharmaceutical industry, from raw material control to content uniformity analysis of the dosage unit.

Honeywell Capitalizes on Plant Knowledge and a Life Cycle of Value
By Aberdeen Group
White paper
In this white paper by Aberdeen Group Inc., Honeywell Process Solutions (HPS), a global solution provider of process control systems, software and related services, is evaluated. HPS's solutions are worthy of review by pharmaceutical manufacturers because plant and business systems are linked while mission-critical applications are kept up and running.

Clarkston survey: Leveraging process analytical technology
By Clarkston Consulting
White paper
In this white paper by Clarkston Consulting, 10 pharmaceutical companies were interviewed about their activity following the FDA's draft guidance on process analytical technology (PAT). The survey found incompatible or unreliable technology and lack of organizational readiness were the most commonly cited hurdles to implementation of PAT.

Contract Manufacturing

Aventis Pharma counts on safety of S900
By ABB Inc.
Case study
In this case study, ABB successfully undertakes a complete automation of an Aventis Pharma plant in Germany, from the control level to the measuring device in the field.

FileNet solutions in manufacturing
By FileNet Corp.
White paper
In this white paper, FileNet Corp. outlines how to create an environment that allows for best in class interoperability of critical business applications in manufacturing/utilities.

Important factors in sourcing large-scale equipment
By A&B Process Systems Corp.
White paper
This white paper by A&B Process Systems Corp. explains factors in sourcing large-scale equipment and explains installed cost, where purchasers often make the mistake of basing their selection of a vendor upon the equipment price alone instead of the installed cost.

Sterile Liquid and Lyophilized Manufacturing Services
By AAI Pharma Inc.
Product collateral
AAIPharma's sterile liquid and lyophilized manufacturing services offer formulation sevelopment for sterile products, preformulation, product development, process development, solutions, emulsions, suspensions, powders, lyophilization, analytical services, compendial testing, and much more.

Softgel Shapes and Sizes
By Cardinal Health
Product collateral
<P>Cardinal Health offers oral technologies in many varying softgel shapes and sizes. </P>

Three Key Trends in Life Sciences Product Supply
White paper
To gain insight into the current issues life sciences manufacturers are facing, AMR Research recently fielded 160 web-based interviews with branded, generic, biotech, and medical device manufacturers.

Data Management

Cerity ECM—protecting intellectual property
By Agilent Technologies
Application note
In this application note, Agilent Technologies describes how to protect intellectual property using its Cerity ECM (enterprise content management).

Enterprise resource planning systems: A case study
Case study
In the late 1990s, drug distribution firm FoxMeyer sued its ERP vendor and implementation specialist, Arthur Andersen, claiming that the ERP installation had driven it into bankruptcy. In this discussion at the University of Singapore, experts dissect the case and lessons that pharmaceutical companies can learn from it when installing ERP systems.

The soft stuff is really the hard stuff: IMA's ERP survival kit
By Implementation Management Associates Inc.
White paper
This white paper from Implementation Management Associates Inc. (IMA) describes its development of AIM, Accelerating Implementation Methodology, a transferable framework to develop an organization's internal capacity to accelerate change implementation.

High-availability server options for critical manufacturing applications
By Stratus Technologies
White paper
This white paper by Stratus Technologies provides an overview of its ftServer systems for the real-time manufacturing enterprise, and describes the effects of unplanned downtime, advantages provided by the servers' fault-tolerant architecture and a comparison with other server alternatives.

Wyeth Farma S.A. meets rigorous FDA standards with Aspen Technology Inc.'s ...
By Aspen Technology Inc.
Case study
In this case study, Aspen Technology Services Inc.'s Weighing & Dispensing solution enables Wyeth Farma S.A. to integrate its enterprise resource planning to the plant floor and meeting US Food and Drug Administration requirements.

Stratus ftService Offerings
By Stratus Technologies
Product literature
This brochure from Stratus Technologies describes its ftService offerings, which are designed to complement and enhance the industry's most robust fault-tolerant servers. The Stratus approach leverages powerful ActiveService capabilities built into every ftServer system, connecting manufacturers to a global service network for detecting, troubleshooting and resolving problems fast.

Environmental Health and Safety

Why Do you Need to be Concerned About Global Hazard Communications?
By American Industrial Hygiene Assn.
White paper
This white paper from the American Industrial Hygiene Association states that if material data safety sheets (MSDSs) are to remain a valuable tool in the protection of workers and others, all industrialized countries must work together to see that they contain the most reliable and accurate data available.

Common hazardous waste issues in the life sciences industry
By Affygility Solutions
White paper
This white paper from Affygility Solutions discusses common hazardous waste issues in the state of Colorado and offers insights into those issues in order to maintain compliance and avoid violations.

Is it time to upgrade your environmental monitoring program?
By Clarkston Consulting
White paper
This white paper from Clarkston Consulting offers four item to highlight the potential benefits that a pharmaceutical company can experience from upgrading their environmental monitoring program.

Econ-o-Tape Strips
By General Econopak Inc. (GEPCO)
Product collateral
General Econopak's Econ-o-Tape Strips are used for multiple applications including positive glove closure, secure boots, mending tears, seal stoppers, and slide prevention.

FDA Guidance for Industry : Manufacturing Biological Intermediates and ...
White paper
The former regulations at 21 CFR 600.11(e)(3) (§ 600.11(e)(3)) required that all work with spore-bearing microorganisms (spore-formers) be conducted in an entirely separate building, or in a completely walled-off portion of a multiproduct building. The Food and Drug Administration (FDA), modified the regulatory requirements for the manufacturing of biological products with spore-formers to...

Lean and Six Sigma

Look before you Lean: Getting returns from Six Sigma and lean manufacturing
By Celerant Consulting Ltd.
White paper
This white paper from Celerant Consulting offers ways to avoid common pitfalls for pharmaceutical companies that employ Six Sigma and lean manufacturing together.

Reaching the Full Potential of Lean Quality
White paper
This white paper by IQS discusses lean quality initiatives and Enterprise Quality and Compliance Management software.

Adapting lean manufacturing for a high-mix environment using flow path ...
By Invistics Corp.
White paper
This white paper by Invistics Corp. describes how to improve manufacturing performance in a high-mix environment using lean manufacturing techniques via flow path management.

Process Equipment

New multiple stream mixer reactor from Microfluidics Corp.
By Microfluidics Corp.
Application note
This application note by Microfluidics Corp. describes its Multiple Stream Mixer Reactor (MMR), a patented continuous mixer/reactor that pressurizes liquids and converts the pressurized energy to intense mixing in a proprietary mixing chamber.

M-210EH Series Pilot Scale Microfluidizer Processors
By Microfluidics Corp.
Product collateral
The M-210EH Series A, B and C Microfluidizer Processors are pilot-scale machines that provide high shear rates, and are available to provide the user with a broad choice of operating pressures and product flow rates.

APSPG Pump Grade Silicone Tubing
By AdvantaPure
Product collateral
Class VI, platinum-cured silicone elastomer comprises AdvantaPure’s new peristaltic pump grade silicone tubing. Suited for pharmaceutical, biotech, and laboratory environments, APSPG is specially formulated to withstand repeated compression and release.

Clean-in-Place Operations for Thin-Cake Filtration Technologies
By BHS-Filtration Inc.
White paper
This white paper from BHS-Filtration Inc. discusses the choice of thin-cake separation technologies and their benefits to optimizing the effectiveness of the production process, and discusses clean-in-place (CIP) operations to meet current Good Manufacturing Practice (cGMP) guidelines.

Comparison guide to C18 reversed phase HPLC columns
By MAC-MOD Analytical Inc.
White paper
This white paper by MAC-MOD Analytical Inc. is a comparison guide to C18 reversed phase high-pressure liquid chromatography (HPLC) columns.

All about fittings
By Upchurch Scientific Inc.
White paper
This white paper by Upchurch Scientific Inc. provides a solid understanding of how high-pressure liquid chromatography (HPLC) fittings work and when to use different fittings products.

Quality Assurance and Control

A new streamlined electronic approach for QA audits and CAPA processes
By AssurX Inc.
Case study
In this case study, AssurX Inc. provides Galderma R&D with a streamlined QA audit system that builds a master audit plan, schedules individual audits, records and reports findings, monitors post-audit actions and complies with 21 CFR Part 11 of the Food and Drug Administration.

Achieving Quality Across the Global Manufacturing Network
By Aberdeen Group
White paper
According to this white paper by Aberdeen Group Inc., best-in-class manufacturers are significantly more likely to have a global quality program and are four times more likely than average performers to empower their decision makers with web-based, integrated technologies.

Improve processes through designed experimentation
By InSite Technologies Inc.
White paper
This white paper from InSite Technologies Inc. describes how one medical device manufacturer attained significant improvement in advancing its process understanding without having to revalidate. The company did this using designed experimentation.

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.

Implementing a proactive enterprise-wide quality system
By AssurX Inc.
Case study
In this case study, AssurX Inc. provides Fischer Imaging with a quality control system that tracks nonconformances and corrective action requests and helps streamline operations and achieve FDA compliance.

The fast guide to OEE
By Vorne Industries Inc.
White paper
This white paper by Vorne Industries Inc. provides an overview of overall equipment effectiveness (OEE), which presents complex production problems more simply and intuitively.

Validation

Improve processes through designed experimentation
By InSite Technologies Inc.
White paper
This white paper from InSite Technologies Inc. describes how one medical device manufacturer attained significant improvement in advancing its process understanding without having to revalidate. The company did this using designed experimentation.

System validation with Experion PKS
By Honeywell Process Solutions
White paper
This white paper by Honeywell Process Solutions describes the FDA's 21 CFR Part 11 validation process regarding electronic records and signatures and discusses how Honeywell can assist with project validation.

Business systems validation for Pfizer production plant
By ABB Inc.
Case study
In this case study, ABB defines a practical validation strategy and detailed implementation plan for a flagship Pfizer plant that produces Lipitor, maintaining Pfizer's excellent regulatory compliance record during a major software transition.

Speed, communication and high-quality science from MDS Pharma Services
By MDS Pharma Services
Case study
In this case study, MDS Pharma Services supports Roche Pharmaceuticals to prepare for an FDA audit by undertaking lot-to-lot validation and other biosafety tests for reagents used in diagnostic kits.

Catching the Drift: What the Specifications of Your Humidity Measurement ...
By Veriteq Instruments Inc.
White paper
Understanding how RH measuring devices function and how those functions are commonly represented in product specifications can help with selecting the right system. Knowing what to look for in product specifications can also initiate incisive questioning of manufacturers about the accuracy of their humidity measuring systems.

Regulatory compliance and validation services
By ABB Inc.
Product collateral
ABB’s regulatory compliance services can assist in dealing with the increasing demands and complexity of national and international regulations.

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