Check list for the Integration of Lyophilization and Aseptic Filling Equipment
Combining lyophilization and aseptic filling processes presents some design challenges, regardless of the integration of one or more...
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Vacuum-Foam Drying: The Alternative for Lyophilization of Biologics?
The complexity of biologics drugs in development continues to increase as the capability in discovery and recombinant technology...
The Challenge of Glass Vial Breakage During Lyophilization
Lyo-breakage is generally not a routine occurrence; however, even at a persistent low frequency it can have significant cost and...
Contamination Control Strategy with Tofflon Isolator
On February 20, 2020, a new draft of EU GMP Annex 1 was finally released. Robotic technology, Barrier System, rapid microbial testing and...
Primary Drying: The Longest and Most Critical Step
Although the entire freeze-drying process is an energy intensive, time-consuming, and economically expensive process, the primary drying...
Adoption of Controlled Ice Nucleation Technology
One of the keys to successful lyophilization is the ability to control ice nucleation so that each vial freezes at the same time and...
Unlock the Potential of Your Vial Filling Line
Glass vial failures, specifically breakage, lensing, and cracks, are a source of product loss and process cost in the freezethaw,...
Lyophilization and COVID19
SARS-CoV-2 is a new virus responsible for an outbreak of respiratory illness known as COVID-19, which has spread to several countries...
Breakage during fill-finish pharmaceutical manufacturing
Fill-finish operations are generally the most capital-intensive stage of the drug manufacturing process — heavy asset utilization is...
Lyophilization of Bacteriophages
Developing resistance among bacteria towards all the available antibiotics makes the clinical treatment of infections more serious and...
Temperature measurement in Lyophilization with Tempris sensors
The importance of product temperature during lyophilization of proteins, microorganisms and other active pharmaceutical ingredients is...
Small Batch Size Lyophilization: A current trend in the biopharmaceutical industry
Patient centered manufacturing instead of a bulk approach is trending in the biopharmaceutical industry. Notably in the fields of...
Unshackling Pharmaceutical Manufacturing With Next-Generation Glass Packaging
Glass is the gold standard material for parenteral packaging applications given its chemical durability, optical clarity, and thermal and...
Monitoring pharmaceutical freeze-drying
The conditions under which pharmaceutical products are freeze dried are subject to strict standards. Satisfying these requirements is...
Lyophilizer Sterilization
A generally recognized acceptable method of sterilizing the lyophilizer is through the use of moist steam under pressure. Sterilization...
Controlled Nucleation in Lyophilization
Nucleation is a dynamic process by which atoms or molecules aggregate to form clusters. The classical theory of nucleation is based on...
Why the Excipients are so Important in a Lyophilized Formulation?
A correctly lyophilized cake needs to have uniform appearance, well stocked to the walls of the vial without falling off from it. It...
The Complexity and Beauty of Lyophilization
The lyophilization process primarily consists of three stages. The first stage is freezing, which involves freezing the product and...
Common problems with lyophilized drugs in the lyophilization process
COLLAPSE Cause: It is a phenomenon which occurs in amorphous solids when the product reaches a higher temperature than the collapse...
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