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How to avoid contamination: Teclen GmbH solution
How to solve contamination issues in freeze dryers with an existing recipe? Teclen can protect your lyo products as well as the operator thr


Freeze Dryer Shelves
The manufacturing of freeze dryer shelves is a key process: as well known shelves are generally considered the most important PCP (product c


The Coming of Age of Lyophilization
Many biotechnologically manufactured substances are not sufficiently stable in aqueous solutions. Because of this, liquid formulations...


Application of QbD principles in the development of lyophilized products in aseptic environment
This article aims to explain, in a very clear way, how the development of a process should be carried out for a vial lyophilized product...


Lyophilization 4.0
The term ‘Industry 4.0’ was first coined by the German federal government in a national strategy to promote the computerization of manufactu


The main effects of the frost buildup on the freeze dryer shelves
Humidity is an essential parameter to consider when we have pre-frozen products to be loaded into the freeze-dryer. These are the most impor


The 6 most challenging samples in lyophilization cycle development
In our previous article about QbD, it was mentioned that lyophilization has been considered an art, and cycles developed by trial and...


Reconstitution Time for Lyophilized products: overcome the challenges!
A number of drugs are unstable in an aqueous environment, even when exposed for a short duration, thus requiring packaging, storage, and...


Isolators available on the Market
Isolators are routinely found within the pharmaceutical industry and are widely used in Europe (and increasingly in the US) for aseptic...


Overcome the distance
Several questions showed up after our previous post, here there is a more precise information about the different strategies and...


Side Maintenance Door or Back Maintenance Door in a Lyophilizer
With integrated Automatic Loading System and/or due to room restrictions, the position of the lyophilizer maintenance door is a delicate...


Silicone Oil Leakage Detection in Freeze Dryers
As a small leakage from the silicone oil tubes in pharmaceutical freeze dryers may go undetected for several cycles, it provides a major...


EU vs China made
The BCG (Boston Consulting Group) stated in an article “For some machinery subsectors in Germany, the threat from Chinese challengers is...


Freeze Dryer Maintenance
As is the case with all categories of pharmaceutical equipment, the maintenance of your freeze dryer depends on 3 HOWs: How you use it...


Miscomprehension about rubber stoppers in Freeze Drying
Lyophilization or Freeze-Drying is broadly used for pharmaceuticals to preserve parenteral drugs properties that are unstable in liquid...

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