Pharmaceutical Engineering July/August 2017

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3D printing and bioprinting have the potential to transform how drug candidates are tested, how drugs are manufactured, the supply chain, and industry dependence on animal testing.

Just Getting Started—3D Printing and Bioprinting in Pharmaceutical Manufacturing

Cover: 3D printing and bioprinting have the potential to transform how drug candidates are tested, how drugs are manufactured, the supply chain, and industry dependence on animal testing. 

A Good Fit—The Marriage of Pharma and Tech Yields Benefits for Patients

Feature: Drug makers are diversifying their portfolios by partnering with technology companies and embracing innovative products such as connected data-gathering medical devices and platforms that collect and analyze patient data.

Applying QRM to Improve Sustainability of Pharma Manufacturing

Facilities and Equipment: As economic pressures and legislated environmental protection measures continue to increase, the pharmaceutical industry is moving to control cost, reduce energy use, and become a better steward of the environment.

In This Issue

Technical

We propose a method for demonstrating content uniformity in the context of variables sampling and relate this to the acceptance criteria and probability of passing the USP CU test. We demonstrate that a variable sampling plan with 99.4% coverage between 83.5% and 116.5% of label content is approximatively equivalent to (and even stricter than) the 95% probability of passing the USP...

Technical

Despite the advantages of ozone technology as a powerful commercially available oxidant and disinfectant, this technology has not been adopted broadly by the pharmaceutical industry. This article contains the rationale for applying ozone technology in a packaged system, which offers greater reliability and efficacy, using best practices that eliminate variables common in on-site integrated...

Technical

The following is an example of an evaluation of room air change rates for potential reduction using QRM, providing more detail on engineering considerations.

Insights

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