A Regulatory Perspective : Rationale for Hold duration of Partially Stoppered Media Filled Vials
Author: Varadharaj Vijayakumar - Aseptic Technology, Isolators & Lyophilization Introduction Aseptic process simulation, also known as a...
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History of Isolators: Development and use of Rigid Isolators including RABS
Early aseptic filling was primitive by today’s standards. It was in the 1930s and afterwards that glove boxes came into use for similar...
Smart TDLAS-based Freeze Dryer Technology: Application to Highly Concentrated Amorphous Systems
Designing a freeze-drying process requires optimization and control of critical product parameters, such as the product temperature (Tp)...
THE LYOPHILIZATION GLOSSARY
ATMOSPHERIC PRESSURE The pressure exerted at the earth's surface by the atmosphere. For reference purposes a standard atmosphere is...
Top Tips for GLP Freeze-Drying
1. To maximize batch uniformity and minimize radiant energy effects, when processing product in vials: Use a full tray of vials. The...
Inspection of Lyophilized Products: What is visual inspection and why is it required? (part 2)
Visual inspection of injections (parenteral) was originally developed and it’s still mainly targeted in order to find and remove products...
Moulded glass vials secure COVID-19 vaccine supply
Although different materials have been trialled and tested, glass remains the most widely used type of primary container for parenteral...
Vaccine Storage as an Immediate Solution
Success is inevitable when professionals start working together. Mirai, Teledoor, Refolution and Secon have joined forces in a joint...
Equipment capability of Freeze-Dryers and its Relevance to the Design Space for Primary Drying
The capabilities of a freeze dryer can change with differences in design. This is particularly important when users are transferring...
Inspection of Lyophilized Products: Introduction & History (part 1)
Inspection and quality control of parenteral products There have been concerns about contamination by particulate matter of injectable...
Covid-19 Vaccines Could Depend on the Strength of This Vial
CORNING, N.Y.—Near the back of a Corning Inc. glassmaking plant here, a robot picked up a cage packed with hundreds of tiny vials and...
MIRAI Intex: ultra-low temperature (ULT) applications between -40 °C and -110 °C
In general, sustainable should mean efficient, reliable and safe for humans and the environment. The air refrigeration machines from...
Selection of Excipients for Lyophilization
Injectable products require a unique formulation strategy. The formulated product must be sterile, pyrogen-free, and, in the case of...
Freeze-Drying with the Air Cycle Technology
Freeze-Drying (also known as lyophilization) is a low-temperature dehydration process. Most dehydration methods use heat to remove the...
Influence of Lyophilization Vials Design on Heat Transfer
Primary drying is known as the most time consuming part of a freeze-drying cycle. With regard to increasing demands to process efficiency...
Freeze Drying and PCR
The current coronavirus disease COVID-19 outbreak caused by severe acute respiratory syndrome SARS-CoV-2 is a public health emergency of...
Latest Innovation in Injectable Solutions
Recently, small batches and patient specific or high-tech medicines for new therapies, such as precision medicine, used for R&D or...
Teclen Lyoprotect Stainless Steel Tray for Lyophilization
The Lyoprotect® Stainless Steel Tray for Lyophilization, multiple use, is designed for freeze-drying of pharmaceutical APIs (Active...
The role of Lyophilization in Fill-Finish Manufacturing
A critical step in the fill-finish manufacturing process, lyophilization removes water from the product after it has been frozen. Modern...
History of Freeze Drying of Vaccines
The origin of lyophilization of vaccines for mass immunization has a very interesting history. The initial advent of this technology as...
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