Topic: Unit Operations

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Taking the Plunge to Harmonize Pharmaceutical Regulations
Within the past five years, more of world's regulatory agencies and pharmacopeias have gotten on the same wavelength.

An Open and Shut Case: The Latest in Valves for Bio
From disposables to diaphragms, a look at what’s new in valves for biopharma.

Building a New Tech Transfer Model
As blockbuster and generic business models merge, tech transfer must change.

Putting Particulates on the Map
Contamination mapping isn’t exactly cartography, but it can be an effective troubleshooting tool.

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White Papers: In Depth Research

Complying With U.S. FDA Title 21 CFR Part 11 for the Life Sciences Industry
Author: SAP
Posted: 04/03/2009
The purpose of this document is to describe the functions and features of SAP ERP that demonstrate technical compliance with U.S. FDA 21 CFR Part 11 Electronic Records; Electronic Signatures Final Rule and several international good manufacturing practice (GMP) guidelines having similar requirements. This document provides background information about the regulation, discusses how SAP ERP complies with this rule, and provides examples of electronic records and signatures within SAP ERP.

Why CAPA Still Matters
Author: Sparta Systems
Posted: 03/19/2009
This article will explore the needs and effectiveness of correct CAPA control, how to implement a successful system and examine just why CAPA still matters.

Using a Coriolis Flowmeter's Multivariable Characteristics to Validate Calibration Stability
Author: Micro Motion
Posted: 10/24/2008
The most common maintenance operation for any flow metering technology is focused around validating the device's calibrations stability over time. This document describes a procedure that uses the multivariable capabilities of a Micro Motion Coriolis flowmeter to provide an in-situ validation of flow calibration stability.

Reduce Contamination Risk with Advanced Local User Notification Indicators for Remote Particle Counters
Author: Hach Ultra
Posted: 10/22/2008
During continuous particle monitoring of a cleanroom environment, a meaningful user notification system near the point of sampling is an important factor in successful intervention and root cause analysis of particle events. Though many remote optical air particle counter suppliers feature a built-in LED indicator in their particle counters, MET ONE 6000 and 7000 series remote particle counters by Hach Ultra provide the most comprehensive set of user notifications through a built-in multi-color LED.

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