Freezing and Annealing Phenomena in Lyophilization
The freezing step of lyophilization is of paramount importance. It is the principal dehydration step, and it determines the morphology...
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Inspection of Lyophilized Products: From Regulations to Implementation and Production (part 4)
We have discussed in previous part 3 the main regulations and requirements about visual inspection covered by USP, EP and JP...
Ensure the Efficiency and Safety of Your Freeze Drying Process
Freeze drying is a critical process for producing biological drugs in vials within the pharmaceutical industry. The FDA estimates that...
Tackling the challenges of small batch manufacturing in fill-finish programs
The biopharmaceutical industry continues to grow rapidly, driven by more specialized treatment protocols and the development of new and...
Molded vial manufacturing and its impact on heat transfer during freeze-drying
Glass vials are the most common primary packaging material used in pharmaceutical freeze-drying. Depending on the manufacturing process,...
Inspection of Lyophilized Products: Defect Prevention vs Removal - QA vs QC (part 3)
According to ISO 9001:2015, quality is: “the degree to which a set of inherent characteristics of an object fulfill requirements”....
The Air Cycle Refrigeration Revolution in Lyophilization - MIRAI COLD 80 T
Mirai Intex is proud to introduce the most powerful refrigeration machine added to their product portfolio. Same as the rest of their...
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...
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...
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