Newsletter | September 24, 2021

09.24.21 -- 5 Misconceptions About Data Integrity In Pharma

Featured Editorial
Industry Insights
The Advantages Of Robotics In Aseptic Fill/Finish

As you move into a future of diverse pipelines that present both great opportunities and big challenges, consider utilizing a flexible solution such as robotics that can be rapidly implemented into your facility.

USP <1207> Updates Leak Testing Recommendations For Pharma Companies

Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and, in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.

How To Ensure Container Closure Integrity Of Combination Drug Products

The rapidly increasing preference toward combination pharma products continues to fuel innovation, while also presenting challenges in implementing a container closure integrity testing strategy.

Benefits Of Blister Packaging For Emerging Markets

Emerging countries offer a nearly untapped opportunity. Despite the opportunities, these markets also hold unique challenges. Blister packaging effectively addresses these challenges.

Key Considerations During A Merger Or Acquisition

Mergers and acquisitions have come to define both growth and consolidation in pharmaceutical manufacturing over the last decade.

Improve Biopharma Fermentation With Innovation, Collaboration

Organizations developing products requiring fermentation often create custom processes from scratch, leaving room for inefficiencies, lost value, and, in the case of significant error, costly time delays.

Improving Uptime In Aseptic Processing Of Pharmaceutical Liquids
Maximized uptime, minimized changeover time, and efficient overall equipment effectiveness (OEE) are key factors that have influenced the acceptance of aseptic blow/fill/seal in the packaging of pharmaceutical liquids.
How Much Will Your Pharmaceutical Powder Screw Feeder Cost?

An efficient feeding system can offer significant return on investment thanks to higher accuracy and better control, despite the higher initial capital investment.

A Guide To Annex 1 Requirements For Particle Monitoring

The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and nonviable environmental and process monitoring. Trend analysis and its impact on the contamination control strategy is now an essential activity referenced multiple times.

Depyrogenation Tunnels Minimize Aseptic Pharma Manufacturing Risks

The two most common methods for depyrogenation are batch ovens and depyrogenation tunnels, but there are different risk levels associated with these two processes. 

Overcome Mixing And Blending Problems In Ophthalmic Operations

Preparing saline solutions is a fairly simple task; however, stabilizers tend to form agglomerates, which cannot be broken down by agitation, and long mixing times are required to hydrate and dissolve the solids.

Five Tests For Pharmaceutical Containment

As APIs increase in potency and become more hazardous to work with, pharmacological and chemical containment devices are required to meet containment performance targets through independent testing before use in laboratories can begin. 

Process Performance Comparison Between New And Legacy S.U.B. Platforms

The Thermo Scientific HyPerforma DynaDrive bioreactor, is now enabling scale-up to 5,000 L and process intensification above previous limits while continuing to leverage benefits of S.U.B.s.

Novel High-Resolution Instrument Helps Institute With Latest Development

Read more about the University of Queensland’s development of the first truly biomimetic hydrogel with the help of an instrument that would be capable of being incorporated into a confocal-microscope system.

Highly Potent APIs (HPAPIs)Are Becoming More Potent And Complex

Dr. Andreas Meudt, the global head of Exclusive Synthesis for Evonik, shares his thoughts on key growth trends for HPAPIs and why more pharma companies are outsourcing their production to contract specialists.

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