Whitepaper
Stopper Migration in Frozen Pre-Filled Syringes
Resource Overview
Parenteral products provided as pre-filled syringes (PFS) offer unique benefits to both the patient and manufacturer. Because the closure system – i.e. plunger – is inherently mobile, environmental factors must be considered to ensure that the sterility of the product is maintained during storage, transport, and handling before administration. Chief among these factors are temperature and pressure fluctuations which occur during transport at elevation or in the holds of aircraft, especially for frozen products.
This whitepaper from Simtra BioPharma Solutions presents a semi-automated method of dynamically assessing plunger migration during controlled variations of temperature and pressure using computer vision tools.
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Methods for Determining Equipment Capability of Freeze-Dryers
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Leak Rate Testing for Freeze-Dryers
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Process Development for Lyophilized Products
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Seasonal Vaccine Manufacturing
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Vial Fogging: Practical Considerations for Vial Selection
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Lyophilization Development for Antibody-Drug Conjugates (ADCs)
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