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Manufacture Quality & Compliance

Turning Failure into Success

| Stephanie Sutton

We should look to Warning Letters – and the subsequent solutions – to benefit from the blunders of others.

Manufacture Facilities

Fumigation of the Future

| Andrew Ramage

A choice of fumigants are available for fumigating microbiological safety cabinets and high-level containment rooms. One substance that is still used in the industry is formaldehyde, but given that formaldehyde is toxic, carcinogenic and corrosive, you’d be better looking for alternatives.

Manufacture Facilities

Embracing Rapid Microbiology

| Tim Sandle

Microbiological approaches are faster and more advanced than ever before – so why on earth isn’t the pharma industry using them?

Business & Regulation Facilities

Sterility Fears at the NIH

| Stephanie Sutton

How did the NIH get it so wrong – and how can it move on?

Business & Regulation Facilities

Investigating the de-agglomeration profiles of dry powder inhaler formulations

In this paper, Srinivas Ravindra Babu Behara, PhD, Researcher; David Morton, PhD, Associate Professor; Ian Larson, PhD, Senior Lecturer; and Peter Stewart, PhD, Deputy Dean & Professor of Pharmaceutical Sciences, all of Monash University; and Paul Kippax, PhD, Product Group Manager, Malvern Instruments, describe the use of laser diffraction to analyse dry powder behaviour. The authors introduce relative de-agglomeration versus flow rate profiles, which represent an effective graphical means to summarise the outcome of the complex interplay between the applied aerosolisation energy and the cohesive forces opposing dispersion in different powder formulations emitted from different inhalation devices. The resulting data can be used as a screening method for developing a formulation strategy for a particular active substance.

Manufacture Facilities

Fill & Finish of the Future

| Susan Dexter

The technology has barely changed over the last 30 years – surely, it’s time for some long overdue innovation.

Discovery & Development Facilities

Laser diffraction and automated imaging: complementary techniques for nasal spray development

This paper reviews the use of laser diffraction (Spraytec, Malvern Instruments) and automated imaging coupled with spectroscopic identification (Morphologi G3-ID, Malvern Instruments) in the development of nasal spray products, showing how the two techniques combine to provide the understanding and regulatory data required to develop and optimize nasal spray products in a cost and time-efficient way.

Manufacture Facilities

Terminal Inertia

| Jeanne Moldenhauer

It is clear that terminal sterilization is the gold standard for sterile drug manufacture, so why are companies so reluctant to pursue it?

Manufacture Facilities

Aseptic ‘Warehouse’ Danger

| James Agalloco

Is there a ‘safe’ hold time for sterilized items? And, if so, how can those hold times be reliably validated?


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