Fulfilling Annex I in sterile drug production: when to use automatic loading and unloading systems for freeze dryers

Sterile drug production has always been a challenging task to perform in the pharmaceutical industry.There are many requirements to fulfill: to assure product quality, to…

How to overcome choked flow limits in freeze-drying processes

In a freeze-drying process, one of the limiting factors in the duration of a cycle is the design of thefreeze dryer, specifically the choked flow…

New trends: Green Engineering, sustainability through a proper design

In today’s situation, sustainability is a more critical concept in engineering projects. Sustainability is related to the ability to meet the needs of the present…

Air flow smoke pattern testing: a new challenge in a subjective test in Annex 1 EU GMP

In the maintenance process of aseptic facilities, one of the tests of high importance is the ‘Air flow smoke pattern testing’ to demonstrate the correct…

Exploring sustainable cooling solutions for freeze dryers. A focus on natural gases

Mechanical refrigeration systems are an important factor against global climate change. With a typical working temperature down to or below of -75ºC, freeze dryer designs…

Automating Format Changes in Pharmaceutical Manufacturing: Enhancing Efficiency, Quality, and ROI

In the pharmaceutical industry, the demand for aseptic flexible multiformat production lines has increased due to the need for small batches, diverse product portfolios, and…

Medical device sterilization with Ethylene Oxide: from a manually operated plant to a fully automized solution

Increasingly the Medical Device industry is challenged to increase the OEE (Overall Equipment Effectiveness) of their manufacturing process. The Ethylene Oxide sterilization lines for medical…

Real-time sublimation front advance monitoring system for GMP freeze-dryers using wireless single use probes as a PAT tool

The advance of the sublimation front during primary drying in a freeze-drying process is one of the most critical parameters whose control is key to…

Optimization of a bio-decontamination process: atomized hydrogen peroxide new cycle development method

Atomized hydrogen peroxide requires a methodical positioning of the load to achieve a correct decontamination.According to GMP regulations, it is recommended to develop a recipe…

Understanding the deactivation capabilities of Hydrogen Peroxide: Bacillus atropheaus vs Geobacillus stearothermophilus

Lethality kinetics study over the two most important sporeformers within the Life Science industry. This article analyzes the hydrogen peroxide deactivation kinetics of representative bioburden…