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Glass is the gold standard material for parenteral packaging applications given its chemical durability, optical clarity, and thermal and mechanical performance. However, conventional glass packaging is not without limitations. All glass containers possess surface flaw...

The conditions under which pharmaceutical products are freeze dried are subject to strict standards. Satisfying these requirements is crucial for pharmaceutical companies for proving that their products have been safely manufactured and are suitable to be used in patie...

A generally recognized acceptable method of sterilizing the lyophilizer is through the use of moist steam under pressure. Sterilization procedures should parallel that of an autoclave, and a typical system should include two independent temperature sensing systems. One...

Nucleation is a dynamic process by which atoms or molecules aggregate to form clusters. 

The classical theory of nucleation is based on the assumption that during the initial stages of the transformation, a few molecules rearrange themselves into droplets or nuclei...

A correctly lyophilized cake needs to have uniform appearance, well stocked to the walls of the vial without falling off from it. It should not have cavities at the bottom and the color should be uniform all around the lyophilized cake, maybe presenting slight differen...

The lyophilization process primarily consists of three stages. The first stage is freezing, which involves freezing the product and creating a solid matrix suitable for drying. This step impacts the drying characteristics of the next two stages. The second stage is pri...

COLLAPSE

Cause: It is a phenomenon which occurs in amorphous solids when the product reaches a higher temperature than the collapse temperature, Tc (closer to the glass transition temperature Tg’). The amorphous phase of the solid experiences internal movement without r...

Freeze-drying is a very gentle dehydration process used for preservation of high quality foods.

During the 1950s, industrial freeze-drying of foods began. Coffee was one of the first freeze dried food products to be produced, but now vegetables, fruits, meats, fish, dai...

The transfer of the recipe from laboratory scale to production scale is one of the biggest obstacles for manufacturers.

Freeze drying is a technology that entails a high energy consumption. A poorly optimized recipe can cause the economic cost of making the lyophilized...

Freeze driers are designed to be chemical resistant to most compounds that are commonly used in freezedrying processes.

However, a freeze dryer is comprised of a number of different materials, some of which may be attacked and degraded by certain chemicals. The degree o...

The lyophilized drugs in the pharmaceutical industry cannot afford to compromise on cleanliness. Lyophilizer contamination results in wasted effort and resources, or worse, creates health and safety issues that can compromise a company’s reputation and customer confide...

In the last 25 years, the percentage of freeze-dried products has increased from 10% to almost 30% of the existing parenteral drugs. In addition, 80% of the freeze-dried parenteral drugs are lyophilized in vials. Vials are the most standardized solution for freeze dryi...

THE FREEZE-DRYING TIMELINE

Looking back to the timeline we see a substantial growth in the usage as well as the technology of freeze drying.

THE FIRST SIGHT

The menial process of freeze drying could first be spotted in the ancient Egyptian culture of mummification, the pr...

Glass vial failures, specifically breakage, lensing, and cracks, are a source of product loss and process cost in the freeze-thaw, cryogenic preservation, and lyophilization of pharmaceutical products. Lyophilization is a common method for the preparation of freeze-dri...

Nowadays almost 50% of the injectable products that are in clinical trials or are approved for marketing, are freeze dried products. Main reasons are the advantages in stability, easy handling during shipment and an adequate solution to cold chain problems associated w...

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Monitoring pharmaceutical freeze-drying

Lyophilizer Sterilization

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