VeriPac 455 for Ophthalmic Product Package Inspection


Ophthalmic products are available in a variety of packaging types and are used for a range of eye care procedures. Foil-covered blister packs for single-use contacts are also included in the forms for liquid-filled packaging, along with soft containers with snap-on or torque screw tops. Most contact lens solutions match certain chemical characteristics of the ocular region while cleaning, sanitizing, lubricating, and removing protein deposits from the lens. Although these solutions may disinfect, contamination is a greater concern due to the fact that they share characteristics with ocular fluids and new bacterial and fungus strains are becoming more resilient. The risk of contaminating the ophthalmic solution increases significantly in the presence of any channel, breach, or microleak in the container seal. Therefore, Container Closure Integrity Testing (CCIT) of ophthalmic products is critical.  

Vacuum Decay technology is a deterministic CCI testing technique that can detect defects as 1 micron.   It is a method that has gained ASTM approval and is a Food and Drug Administration (FDA) consensus standard that has been shown to provide accurate, repeatable, quantitative findings. Compared to manual visual inspection techniques, Vacuum Decay technology makes use of a specially designed test chamber to eliminate false positives and subjective findings. It provides a more effective laboratory testing technique with rapid findings, with test times of less than 30 seconds for each sample tested. 

 

Ophthalmic Product Package Integrity Testing Using VeriPac 455  

 

VeriPac 455 is a non-destructive inspection system for highly sensitive micro leak detection of liquid-filled containers and ophthalmic product packages. The technique is non-destructive, non-invasive, and requires no sample preparation, so, it can be incorporated into protocols at any stage of the handling process. Applications for this technology include statistical process control (SPC)  in production, quality assurance testing, and stability studies for clinical trials. 

 

The FDA has recognized VeriPac 455 as a consensus standard for pharmaceutical package testing. VeriPac leak testing equipment was used to create this testing method. The PERMA-Vac dual vacuum transducer technology featured in the VeriPac 455 increases test sensitivity and provides reproducible dependable results. In addition, the VeriPac 455 includes substantial networking and internet connectivity advancements that make it easier to operate remotely, monitor systems, and integrate MES. 

 

Technology Overview 

 

A test chamber that is specifically made to enclose the package being evaluated is connected to the VeriPac 455 leak tester. The container is placed within the test chamber, which is under vacuum. The test chamber is monitored for both vacuum level and change during a predefined test duration using the dual transducer technology. The existence of leaks and defects within the package is indicated by variations in the absolute and differential vacuum. The sensitivity of a test depends on the transducer's sensitivity, the design of the package, the fixture used to test the package, and the crucial test parameters of time and pressure. Test systems can be designed to operate automatically or manually. This inspection technique is appropriate for QA/QC statistical process control and laboratory offline testing. Only a few seconds are needed for the test cycle, and neither the product nor the package is damaged during testing. 

 

Benefits of VeriPac 455  

  • Non-destructive, non-subjective, no sample preparation. 
  • Highest level of sensitivity, reproducibility, and accuracy. 
  • Defect detection capacity down to 0.01 cc/min. 
  • Encourages zero-waste initiatives and sustainable packaging. 
  • Results that are more effective than dye ingress. 
  • Deterministic, quantitative test technique. 
  • FDA-recognized standard and ASTM test protocol. 

Ophthalmic drug products intended for the treatment of acute conditions demand strict packaging and safety considerations. Vacuum Decay technology has been proven to be a practical solution for ophthalmic package integrity test solutions. It is a non-destructive CCI technique that can evaluate both liquid and air-filled containers. 

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