Aseptic Processing Resource Center

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Imaging the Blending Process
Hyperspectral imaging can be used to optimize blending, by monitoring the distribution of excipients and APIs in formulation.

Process Validation Guidance: A Bad Fit for Aseptic Processing?
“Science-based” is well and good, but FDA’s guidance may create confusion.

Risk Management in Pharmaceutical Microbiology
At look at how HACCP and FMEA can make a difference in the pharma micro lab.

Therapeutic Dose: Facilius per Partes in Cognitionem Totius Adducimur
We are more easily led part by part to an understanding of the whole. –Seneca

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White Papers: In Depth Research

Rotary Tank Cleaning and Cost Savings
Author: Gamajet
Posted: 04/11/2011
Specific case studies on the benefits of rotary impingement and CIP optimization vs. the standard tank cleaning processes. Benefits include: increased revenue and production with drastic reductions of operating costs pertaining to tank cleaning.

Cartridge Filtration in the Production of Pharma Grade Water
Posted: 07/26/2010
Cartridge filtration can be a reliable, efficient means of producing bulk pharmaceutical grade water. This detailed paper from 3M illustrates its effective use for some of the most critical applications: the removal of particulates that might contaminate water systems, eliminating Pseudomonades and other microorganisms, reducing endotoxins, and protection of storage tanks during draw-down.

Six Key Predictors of Outsourcing Success In A Maturing RE & FM Outsourcing Market
Author: UMS Advisory, Inc.
Posted: 01/07/2010
In this white paper, Nicole Ballard and Rakesh Kishan of UMS Advisory, Inc., provide an overview of the RE & FM Outsourcing Market and address main waves of market maturity. In particular, they examine significant outsourcing deals.

Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers
Author: Microtest Laboratories
Posted: 09/21/2009
Environmental testing and monitoring programs are essential elements in pharmaceutical and medical device manufacturing. Companies must understand industrial sterilization and contamination control procedures to bring products to market on time and on budget. Steven Wieczorek of Microtest Laboratories reviews the key elements of a best-practice environmental testing program, including sterilization standards, FDA requirements, and the critical factors in maintaining controlled environments.

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