Displaying 151–175 of 309 results for USP

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Will Pharma Ditch the Dish?

(Article)

Rapid Microbial Methods (RMM) are gaining acceptance, but traditional microbiological testing, and the classic Petri dish, promise to be around for years to come.

From Drinks to Drugs: A Proposal for Advancing Aseptic Processing and ...

(Article)

The status quo in the beverage industry provides a glimpse at what the future of pharmaceutical aseptic processing could be.

Pharma’s Evolving Quality Systems: Views from ASQ’s National Director, Donald...

(Article)

The Malcolm Baldrige National Quality Award Examiner, certified specialist microbiologist and Six Sigma Green Belt recently shared his views on where the industry is heading and what it needs to improve.

Thermo Fisher Scientific

(Product)

Thermo Fisher Scientific Inc. has introduced the Thermo Scientific Nalgene Certified Clean PETG Containers.

Interphex Stands Test of Time (and Economy)

(Article)

Despite a tough economy, few question the value of attending Interphex, and this year’s show promises to be as good as ever.

Global QC: On the Front Lines With DQI’s Patrick Lukulay

(Article)

USP’s Drug Quality and Information Program is establishing training programs around the world. Its Madagascar program offers a model.

Mettler Toledo

(Product)

Mettler Toledo introduces Version 5.2 of its FreeWeigh.Net, a powerful, comprehensive software solution for quality control in pharmaceutical production.

The Third Way for ICH Q7A: A Proposal for Updating Guidance for API Inspections

(Article)

There are not just two choices for API analysis—“old time” wet tests or super-sophisticated science-based tests—but also a third way. a combination of on-site qualification and use of targeted PAT equipment.

January 2009

Measuring Samples Per USP 26 Using Shimadzu TOC-VW

(Whitepaper)

The United States Pharmacopoeia has established guidelines for determining system suitability and established the acceptance of Water For Injection (WFI) purposes and Purified Water (PW) (USP Revision 26 method <643>). Shimadzu’s TOC-VW analyzer is adapted to meet the requirements of USP Rev. 26 ...

Fact or Fiction: Automated Dissolution Testing Reduces Operator Error and ...

(Whitepaper)

While the automation of dissolution testing is primarily touted as a means to reduce operator bench time, the reduction in operator error is often overlooked. In fact, many pessimists argue that the calibration and service hours associated with automation negate the overall reduction in operator ...

USP Acceptable TOC Levels for Pharmaceutical Water: How to Achieve Them?

(Whitepaper)

Meeting the regulations and validation rules is an important task for the pharmaceutical industry. In order to be compliant with the regulations and meet the required quality and safety standards, the pharmaceutical industry must develop economical and competitive production and cleaning methods,...

USP acceptable TOC levels for pharmaceutical water: How to achieve them?

(Whitepaper)

Compliance with acceptable TOC levels in pharmaceutical water regulations must be maintained within the pharmaceutical industry throughout different manufacturing processes. This white paper attempts to classify these necessary regulations and compliance through preparation, production and waste ...

Jim Akers Knows Your Dirty Secrets

(Article)

We’re on the cusp of an aseptic processing sea change, Akers says, and you are to thank for it.

ANATEL TOC600 Online Total Organic Carbon Analyzer

(Whitepaper)

ANATEL TOC analyzers are the industry standard for purified water and ultrapure water. The ANATEL TOC600 provides online TOC analysis for a range of applications requiring USP Chapter <643> and EP Chapter 2.2.44 for TOC requirements, as well as USP Chapter <645> for conductivity measurement. The ...

ANATEL PAT700

(Whitepaper)

The ANATEL PAT700 is a science and risk-based on-line TOC analyzer that simplifies the application of process analytical technology in life science water system applications. Designed as a fully compliant TOC analyzer that meets the requirements of USP <643> and EP 2.2.44 for TOC, USP <645> and ...

ANATEL A643a Total Organic Carbon (TOC) Analyzer

(Whitepaper)

The ANATEL A643a offers reliable, robust performance in water system-critical TOC monitoring. Designed specifically to meet the needs of the pharmaceutical market, the ANATEL A643a is fully compliant with industry methods including USP<643> and <645>, EP 2.2.44 and JP XV<60>. With a number of key...

HIAC 9705 Liquid Particle Counting System

(Whitepaper)

HIAC quality and reliability take new shape in the 9705, with exciting developments in liquid particle sampling technology. An innovative sampling process, housed within the 9705’s streamlined case, provides consistent dispersion and highly pure sampling. The 9705 sets new standards for accuracy ...

ICH Guidances (Already) Show Their Age

(Article)

ICH guidelines can be powerful tools for PAT/QbD, but some, such as ICH Q2 (R1), need updating.

(Blog)

Digital Insights: Exclusive Content? I Do.

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The Global Supply-Chain: Or, Which Shell is the Pea Under?

(Article)

There are solutions to making raw materials safer, but they involve coordinated technology and efforts.

Contractor Corner: Microtest’s Supply in Command

(Article)

A mid-size CMO knows from where its raw materials come, and continues to grow.

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