Monday 11 October 2021

Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity


The presentation of pharmaceutical preparations in the form of prefilled syringes continues to grow. The addition of drugs in prefilled insertable and disposable cartridges is driven by manufacturing economics (including the avoidance of overfill, common with dispensing into vials, which saves on product yield); clinical preference, including better accuracy of dose delivery and avoiding the cross-contamination that can occur with a separate syringe and vial; and an expansion of medications that can be self-administered by the patient in the home. The syringe plays a dual role in the prefilled syringe product — as a container closure system and as a delivery device.



Prefilled syringes vary in terms of their method of manufacture, method of filling syringes with a drug product, and the types of syringes available. Several variations are required due to product incompatibility in particular drug combinations and material types. Products in prefilled syringes must be chemically, physically, and biologically stable and, based on the route of administration, the combination product must be sterile and apyrogenic. Product manufacturing requirements are set out in the ISO 11040 standard, such as Part 8, which presents the “Requirements and test methods for finished prefilled syringes.” One important aspect of assessing prefilled syringes relates to the integrity of the filled syringe. The process of assessing integrity is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.




Sandle, T. (2021) Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity, Pharmaceutical Online, 18 August 2021;


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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