HVLD(Low voltage) methods for CCIT(container closure integrity testing)
‘No one test is appropriate for all packages or for all leak testing applications’ (USP <1207, FDA presentations and rticles), A ‘toolbox’ of CCI test methods should be standard configuration for the big pharmaceutical company who need to meet the international market or CDMO company need to face different products from their customers.
Some questions should be considered when choosing the method:
- What package type is being tested: a vial, syringe, or IV bag, etc.?
- How is the container sealed or closed? Melting or with rubber stopper?
- What is the product inside the container? Liquid, Big molecule or sticky?
- How full is the container and is there head-space in it?
- How will the container be used; what processes will it undergo?
- At what temperature(s) will the container be stored and shipped?
High voltage discharge method should be a must have method in your methods box.
Biggest advantages：
· HVLD is a non-destructive test method.
· There is absolutely no secondary contamination to the product.
· HVLD can detect small pinholes in pharmacy packaging that would not be normally found through other inspection methods.
· HVLD is designed for continuous 100% in-line inspection and defective containers are automatically rejected from the production line.
· a variety of products and containers can be inspected on the same equipment with minimal changeover time.
Principle Of HVLD Inspection
HVLD is based on the principle of using a high voltage spark-test system, and it is capable of handling any product as long as:
· the container is made of electrically insulated material
· the product contains an electrically conductive solution.
The high voltage being applied is seeking the least resistive path to the product. The increase in the current volume through the product determines whether the container is good or defective.
Applications For High Voltage Leak Detection
All liquid filled, non-metallic containers, including glass vials, glass ampoules, BFS containers, prefilled syringes, IV bags and other types of flexible packaging are applicable for HVLD technologies.
The PVC IV bag market is growing fast as is the market for non-PVC IV bags.In the event of an IV bag leak, contaminants including microorganisms, reactive gases, and other substances (United States Pharmacopeia (USP) 1207) could potentially cross a container closure barrier adversely affecting the solutions within.
HVLD(low voltage charged) method-update of traditional HVLD
Lossless (Methodological upgrade)
? Strong anti-interference (water droplets, air layer)
? Wide range of application (e.g. low conductivity)
? High sensitivity
? Manage material simple
? Special electrode brush (customized)
? Overall detection (mouth position, edge position)
? Perfect solution to the challenges of traditional methods
Relative products:
