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MicroCurrent HVLD Technology Whitepaper

The document discusses container closure integrity (CCI) testing for parenteral products like vials and syringes, which must maintain a sterile barrier. Traditional CCI testing methods are probabilistic and unreliable. High voltage leak detection (HVLD) technology provides a more deterministic approach. PTI's MicroCurrent HVLD technology further improves on HVLD by allowing for the testing of products with very low conductivity and by reducing voltage exposure and ozone production compared to other HVLD methods. MicroCurrent HVLD provides quantifiable and validated test results suitable for high-risk parenteral packaging.

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24 views2 pages

MicroCurrent HVLD Technology Whitepaper

The document discusses container closure integrity (CCI) testing for parenteral products like vials and syringes, which must maintain a sterile barrier. Traditional CCI testing methods are probabilistic and unreliable. High voltage leak detection (HVLD) technology provides a more deterministic approach. PTI's MicroCurrent HVLD technology further improves on HVLD by allowing for the testing of products with very low conductivity and by reducing voltage exposure and ozone production compared to other HVLD methods. MicroCurrent HVLD provides quantifiable and validated test results suitable for high-risk parenteral packaging.

Uploaded by

MohammadIsmail
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Inspection Systems

A Paradigm Shift in Container


Closure Integrity of Parenteral Products
MICROCURRENT HVLD TECHNOLOGY

MICROCURRENT HVLD TECHNOLOGY

Container Closure Integrity (CCI) is defined by whether a container maintains the sterile barrier. If there is a leak or breach
of the sterile barrier, environmental contaminants can rapidly convert a life saving treatment into a microbial soup.
Parenteral products are the highest risk of all package formats. Vials, ampoules and prefilled syringes have the highest
potential for microbial growth, and the risk to the end patient amplifies the focus needed on CCI for these applications.

Historically there have been a variety of test methods used for parenteral CCI testing. The use of less sensitive and archaic
methods has evolved to better procedures and newer technologies. There is still a level of misinformation and a reliance on
probabilistic solutions for CCI testing of high risk parenteral products. Regulatory bodies have initiated the shift to more
deterministic test methodologies that can be controlled, calibrated and provide a definitive determination of CCI.

High voltage leak detection (HVLD) has been a common technology on the market for decades. The latest evolution of HVLD,
PTI’s patent pending MicroCurrent technology, aims to achieve a high level of CCI assurance across the entire range of
parenteral products. High voltage leak detection is a method included in USP 1207 as a deterministic test methodology and
is an established and reliable solution for all liquid filled parenteral products.

TRADITIONAL METHODS

The dye ingress and microbial ingress methods have been traditional methods deployed for parenteral CCI.
The ability to detect defects varies greatly, and there is no global standard to perform these methods. USP 1207 has clearly
outlined these methods as probabilistic and for good reason.

While vials and ampoules do have the physical requirements to perform an ingress test, the method does not provide the
certainty of detecting critical defects. For package formats such as a prefilled syringe or cartridge, the lack of internal
headspace makes these methods even less effective. The general probabilistic nature of these methods is exacerbated by the
difference in physical properties of each package type. With a method that has a variable probability of detection there is one
fundamental question, how can it be validated? The simple answer is that both the blue dye and microbial methods struggle to
produce validation worthy test results befitting of high risk
packaging applications.

The blue dye ingress method and the microbial ingress method can be largely described as qualitative in nature, with a simple
pass/fail result. The destructive nature of the test makes test results finite despite the probabilistic nature of the result, making
it almost certain that at some point batch release data will be inaccurate, sending good product out to market or issuing a flurry
of remedial actions based on a false reject.

914.337.2005 [email protected] www.ptiusa.com 145 Main Street Tuckahoe, NY 10707 7/2017


ADVANCES IN DETERMINISTIC PARENTERAL
CONTAINER CLOSURE INTEGRITY
inspection
electrode pinhole
HVLD operates on the simple property of electrical current. The package barrier must be or crack
non-conductive and would resist voltage from passing through, while the package contents
should generally be able to carry voltage. Liquid products with a conductivity of 5 micro-
siemens and greater meet the requirement for PTI’s MicroCurrent HVLD.

The container is placed horizontally on a rotating stage. While rotating the container, high
voltage is applied to one side of the container and a ground probe on the opposing side.

If the package has no leak, the two container walls (high voltage side and ground side)
detection
provide full electrical resistance and no significant current is measured passing through the
electrode MicroCurrent HVLD
vial. If there is a micro-leak or crack in one of the container walls, the break-down
resistance is reached and the current passes through.

HVLD is the only leak detection technology that does not require mass
to pass through a defect site, requiring only the passage of electricity
through a crack. This characteristic makes HVLD sensitive to leaks in
which most leak test solutions cannot identify.

PTI’s MicroCurrent HVLD technology uses unique voltage


characteristics to inspect a wide range of parenteral products.
Traditional HVLD has proven to be an effective solution for standard
parenteral products, but requires a level of conductivity for the liquid
contents of the package. PTI’s MicroCurrent HVLD greatly increases the
range of liquid conductivity that can be tested, with the technology
capable of testing water for injection (WFI) and other liquids in the
single digit micron range.

The MicroCurrent HVLD reduces voltage exposure to the product to less


than 5% of the voltage exposure experienced when testing with
comparable HVLD solutions. Reducing exposure voltage not only
reduces any risk that the voltage poses to the product, but also greatly
reduces the production of Ozone during operation when compared with
traditional HVLD solutions. Ozone in the headspace of a container can
be detrimental to the product, and in the operating environment can
affect respiratory health. Experiments have shown that PTI’s
MicroCurrent HVLD produces essentially no Ozone.

DETERMINISTIC, Product HV Exposure Ozone Creation


QUANTITATIVE TEST
METHODS PROVIDE:

• Hard traceable data


• Discrete pass/fail limits
• The ability to calibrate a system
• Avoidance of subjective influences in results
• A reliable test method that can be validated
and rolled out globally

914.337.2005 [email protected] www.ptiusa.com 145 Main Street Tuckahoe, NY 10707 7/2017

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