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Lyophillizer Validations, Aseptic Process simulations design-Lyo process and Rationale for Hold duration of Partially Stoppered Media Filled Vials-In compliance with Revised EU Annex-1 2022 (part I)

Author: Varadharaj Vijayakumar - Aseptic Technology, Isolators & Lyophilization After two draft documents from 2017 and 2020, more than...

Cryopreservation vs. Lyophilization: Decoding the glass transition phenomenon

In the realm of preserving delicate biological substances and pharmaceuticals, two prominent methods take centre stage: cryopreservation...

Freeze Drying: Facts vs. Fiction

Introduction Freeze drying, also known as lyophilization, is a vital process in the production of many pharmaceuticals, diagnostics, and...

Stability to probiotic cultures and functional foods ingredients

There is accumulating clinical data supporting the role of probiotics in human health particularly in benefiting the immune system,...

How To Ensure Your API Is Compatible With Its Formulation

Years of hard work and research go into developing new APIs, so when it comes to developing one into a new formulation for mass...

Freeze Drying Process Steps

Freeze drying is а three step linear process: Freezing, Primary Drying, and Secondary drying. Each step is outlined below. Freezing The...

How freeze drying optimises the processing and viability of collagen bio-scaffolds

Collagen bio-scaffolds are hugely beneficial to many medical fields and therefore it is essential that the process used to develop them...

Considerations When Freeze Drying Tissue

Although freeze drying was originally developed for biological products, as described in publications as early as 1935, there has been...

Common and Uncommon Lyophilization Mistakes

Introduction Lyophilization, or freeze-drying, is a process of removing moisture from a product while preserving its quality, integrity,...

CIP evolution in freeze dryers. Optimize turnaround time & water consumption

In sterile manufacturing with freeze dryers, CIP process plays an important role to prevent contamination to the product and to comply...

A bright future for Lyophilized drugs

What are lyophilized drugs and why are they becoming a trend for the future? Lyophilized drugs have been around for decades, but the...

Freeze Drying Cannabis

Growing cannabis is a process that requires dedication and, above all, patience. This is well known to experienced cannabicultors since,...

Reducing the Risks of Particles on the Outside of Vials

Historical Justification for External Washers The implementation of post capping external vial washing (decontamination) within the...

Why and how to carry out thermal characterization of a product before lyophilization?

In this interesting article, Antoine Babin of Biopharma Technologies France provives an overview about why thermal characterization in...

The EU Annex 1: Lyophilization

Finally, on 22 August 2022, the new Annex 1 of the EU GMPs was published. Manufacturers do not need to panic though, the new standards...

Data Logging Solutions Meeting Lyophilization Challenges

Production of pharmaceuticals is so complex and requires such precision, the last thing pharma manufacturers need is vital equipment that...

Integrated Overall Solution for Vial Sterile Lyophilization (part 3)

Application of lyophilization technology started in early 1980s. Lyophilization refers to the method that freezes Liquid into solid by...

FAQ Teclen Customers

Which solvents can I use with the membrane? The membrane material is expanded polytetrafluorethylene (ePTFE), that means nearly all...

Superior results and efficiencies achieved in Food Freeze Drying

Water is generally the main ‘ingredient’ in food and has a considerable impact on both physico-chemical and mechanical properties, which...

Integrated Overall Solution for Vial Sterile Lyophilization (part 2)

Freeze-dryer auto loading & unloading system come into use in early 1980s, and it is a full-automatic connection equipment that uses...

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