Role of CCI in Maintaining the Sterility of Sterile Injectable Products


Nowadays,  it is crucial to determine a strategy for container closure integrity testing of sterile injectable products. Sterility has historically been connected to container closing integrity. Microbial contamination is possible when a container's closure integrity is compromised. While container closure integrity has evolved through time, the scope of its use has expanded.  

Drug packages must have container closure integrity (CCI) in order to remain sterile during their shelf life. The defects that lead to the leakage of sterile vials are not always defects, that may be recognized visually.  If the defect is hidden by the crimp, microscopic cracks, or is a transient one like a stopper pop-up, then the container will leak temporarily until it is repaired.  

CCI test methods 

 

There is a lot of uncertainty in the findings of traditional CCIT methods, such as microbiological challenge tests or blue dye ingress tests. This makes it difficult to quantitatively validate them for detecting significant leaks. In 2016, the USP<1207> updated with the new chapter 'Package Integrity Evaluation - Sterile Products', which gives a brief review of various CCI testing technologies. Now, let us have a look at some of the CCI test methods that play a significant role in maintaining the sterility of sterile injectable products.  

 

MicroCurrent HVLD Technology 

 

In the USP<1207> chapter guidance, MicroCurrent HVLD is referenced as a deterministic test method for container closure integrity testing. It is a patent-pending unique high voltage leak detection technology that is highly effective across all parenteral products. When compared to standard HVLD technologies, this technique uses almost 50% less voltage and exposes the product and surroundings to less than 5% of the voltage.  

 

The Microcurrent HVLD test technique may detect pinholes, microcracks, stopper/plunger leaks, non-visible leaks under crimping, and many other defects. CCI is assured by scanning a sealed container using electrode probes. It is possible to determine the approximate position of the defect by measuring the difference between resistance and current flow within a container that has a defect. Pre-filled syringes, vials, cartridges, ampoules, BFS, bottles, and pouches can benefit greatly from this method.  

 

Vacuum Decay Technology 

 

One of the most practical and sensitive vacuum-based leak detection methods for CCI testing. Using this test, you can get a quantitative result that is dependable, reproducible, repeatable, and accurate, as well as a definite pass or fail result. To do this, a test chamber is used to draw a vacuum on a package and monitor the vacuum level for any deterioration that would suggest a leak. This is a non-destructive method that is an alternative to the water bath leak test. It saves a lot of money by not wasting items on leak tests, and many products have a quick return on investment. 

 

Good container closure integrity is necessary for the maintenance of sterility and stability of sterile injectable products. Sterile injectable products must be kept sterile and stable by maintaining good container closure integrity.  Sterility assurance of a parenteral drug product is a regulatory requirement before it may be used on humans.  

 

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