Finished Product Testing For Lyophilized Products
There are several aspects of finished product testing which are of concern to the lyophilized dosage form. These include dose uniformity...
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Thinking of the Development Trend of Sterile Freeze-dried Injection
On February 20, 2020 the Directorate for Health and Food Safety of the European Commission published a further draft for the revision of...
Why Perform Batch Control the Freeze Drying Process
Why Perform Batch Control of the Freeze Drying Process? Almost half of all biological products produced within the pharmaceutical...
PCR Diagnostic Kits & Freeze-Drying Considerations
PCR Process Overview Polymerase chain reaction (PCR) is a method widely used in molecular biology to make many copies of a specific DNA...
Inspection of Lyophilized Products: Container Closure Integrity (part 5)
Commonly referred to also as "Leak Control/Testing" or "Integrity Test", the CCIT (Container Closure Integrity Testing) is intended to...
Organic Solvent Recovery
Recovery of solvents from process streams is necessary, from both ecological and economical points of view. The goal is to recover,...
Considerations for Freeze-Drying in Dual Chamber Package Systems
Many parenterals, especially biotherapeutics, are unstable in aqueousbased formulations for long periods of time and are, therefore,...
Minimizing Aseptic Pharmaceutical Manufacturing Risks with the Inclusion of Depyrogenation Tunnels
Introduction Regulatory agencies prefer injectable products to be terminally sterilized. For some products, such as biological drugs,...
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...
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...
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