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Balancing Compliance and Cost for Life Sciences IT

(Whitepaper)

Mid-sized life science companies have most of the same business requirements and face all the same regulatory issues as large companies, but have fewer resources to address those issues. This document outlines compliance strategies that allow mid-sized firms to balance risk with cost when ...

The Role of Taggant Technologies in Combating Counterfeiting

(Whitepaper)

Pharmaceutical counterfeiting and gray marketing pose a growing threat to both patients and drug companies. When considering brand protection and product security, it is important to know what and where the threat is, and what technologies will be most effective in combating it. This paper from ...

Maximizing Contamination Control with Vacuum Technology

(Whitepaper)

Since November 2001, ISO Standard 14644-1 has defined the criteria cleanrooms must meet in order for pharmaceutical manufacturers to stay on top in today’s increasingly competitive market. As drug makers work to meet this rigorous standard, they must seriously evaluate and improve their ...

Cyclojet: A Powerful Chromatographic Tool for Binary Separations

(Whitepaper)

An elegant way to increase productivity of batch chromatography (HPLC), in the case of binary separations, is to use a concept known as steady-state recycling (SSR) and commercialized under the name Cyclojet. This concept is implemented on the Novasep Hipersep line. Cyclojet is particularly ...

Improving Time to Market: Drug Manufacturing's Lean Imperative

(Whitepaper)

Lean business practices, better IT integration and "servant leadership" are becoming essential to survival in pharmaceutical manufacturing. This white paper from Oracle Corp. discusses how some drug makers are implementing those solutions.

Sterilizing Filtration for Oxygen-Enriched Processes

(Whitepaper)

Modern aeration in bioprocessing increasingly relies upon gaseous oxygen to enhance cell culturing productivity. Oxygen-enrichment techniques, however, require added caution against bioreactor contamination. For this reason, sterilizing grade gas filters have become the preferred choice for ...

The Effect of Water on Low Temperature Heat Transfer Fluid Performance

(Whitepaper)

Water contamination of low-temperature heat transfer fluids is often blamed for poor performance in industrial cooling processes involving liquid nitrogen. This study simulated the coil freezing characteristics of 3 fluids - Paratherm CR, silicone and a d-limonene blend - at varying levels of ...

Advantages of Disposable Membrane Technologies for Purifying Gene Therapy ...

(Whitepaper)

Vectors (plasmids, viruses) for genetic therapies are complex to produce and purify. This white paper provides an introduction to vector production (at clinical trial scale) for gene therapy and illustrates the use of membrane chromatography technologies for capturing Adeno-associated virus vectors.

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, ...

Recovering and Refining Precious Metals from Spent Pharmaceutical Catalysts

(Whitepaper)

Many pharmaceutical production processes use precious metal-bearing catalysts to facilitate reactions and to eliminate harmful end-of-pipe emissions. Although these catalysts typically represent a small portion of overall pharmaceutical manufacturing costs, they are by no means insignificant nor ...

Using ERP Software to Achieve 21 CFR Part 11 Compliance

(Whitepaper)

This white paper discusses how mySAP ERP software can help life sciences companies comply with the FDA’s 21 CFR Part 11 — the regulation on electronic records and signatures — as well as international good manufacturing practice guidelines having similar requirements. It also addresses ...

The Drive for Growth and Compliance in Life Sciences

(Whitepaper)

The pharmaceutical sector faces pressure on many fronts, as market competition continues to raise the stakes in regulatory compliance and the pursuit of cost efficiency. This SAP white paper illustrates how finding a technology partner that can provide a comprehensive IT solution, versus ...

Contract Life-Cycle Management: A Holistic Approach to the Creation, ...

(Whitepaper)

Contract management may well be more complex for life sciences than for any other industry. Growing demands from customers, government regulators and managed care organizations further complicate the process. However, as this white paper from SAP explains, an integrated, enterprise-wide software ...

Ensuring Pharmaceutical Process Performance at Very Low Temperatures

(Whitepaper)

Many manufacturing processes used today in pharmaceutical manufacturing operate at lower temperatures than can be capably met by existing heat transfer fluids. This article will discuss both how Therminol VLT can help drug manufacturers and what technical services should be expected from the heat...

Application Note: A Heat Transfer Fluid for All "Seasons"

(Whitepaper)

Many processes currently used in pharmaceutical manufacturing operate at lower temperatures than can be capably met by traditional heat transfer fluids. However, technological advances have enabled the development of a fluid with a low-use temperature of -175°F (-115°C) and a maximum ...

Eliminating Ferrous Contamination in Critical and Sterile Equipment Maintenance

(Whitepaper)

Although the pharmaceutical industry is highly automated, key decisions are still made by individuals. In critical and sterile processing, even seemingly small decisions can affect productivity and regulatory compliance. In this paper, Steritool's Brian Pekarsky discusses how to implement a ...

Residual Solvents by Teledyne Tekmar HT3 Headspace Autosampler and GCMS

(Whitepaper)

This application note describes the use of a gas chromatograph/ mass spectrometer along with a headspace analyzer as a routine method for analyzing residual solvents from drug manufacturing processes. Study data showed that using static headspace for residual solvent analysis is a cleaner ...

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 ...

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.

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 ...

A Uniform Approach to HACCP

(Whitepaper)

With food safety awareness elevated throughout the global food supply chain, processors must take a proactive approach to controlling hazards. Most food plants have HACCP plans to address food safety and sanitation issues, but uniforms are often overlooked as a critical control point.

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