CCI 1000 is the new , state of the art, vacuum decay based, testing instrument capable to measure on various types of containers made of glass, plastic, metal, flexible composite :
· Liquid filled ampoules
· Sealed Vials (empty, Liquid or lyo filled)
· Pre-filled syringes (liquid filled or empty)
· Pouches and sachet
· Bottles, filled and sealed
· Bulk containers small size
· Ophtalmic dropper tip
VOLTA is a nondestructive High Voltage Leak Detection (HVLD) bench top unit for package integrity testing of liquid filled containers.
The QESSE VOLTA is the excellent solution for reliable detection of microcracks or pinholes affecting the sterility of containers.
Explore the key feature
Touchscreen
12" touchscreen with large button enabling easy operation, the touchscreen software is simple and user friendly.
The machine owner can control access, recipes and methods, datas and performing test. Furthermore the user can print or export results.
The software ensures GMP compliancy if needed.
Buttons
Instrument is equipped with two buttons for starting and stopping the testing operation making it easier and robust, even when wearing multiple gloves, no need to touch the panel.
The two buttons are indicators of PASS/FAIL (green/red light) helps the operator to visually understand if the sample is leaktight.
Measuring adaptor
In order to maximize sensitivity a special tool especially dedicated for sample size is developed to suite the user needs and testing optimization.
Multiple tools can be connected to the instrument or multiple size can be adapted to one adaptor tool.
Based on sample type we will provide a standard or a tailored solution.
CCI1000 can measure blister packages we can support you for method development.
Measuring syringe, vials or ampoules empty or filled with a MALL down to microns.
Medical device package can be tested with dedicated tools and methods.
Vacuum decay is a test method used to test package integrity. A sample is placed under controlled vacuum condition. The difference in pressure from the internal atmosphere of the package and the external will force the internal gas to move toward the external area of the packaging. The flow occurring will produce an increase in pressure. This increase will be measured and quantified during the test time.
The increase in pressure based on empirical test will be different in case of a leaking package or a leaktight package and the software will automatically detect the higher increase of a leaking package showing a FAIL result.
This technique is nominated as deterministic in USP <1207>, usually accepted as an FDA consensus method for packaging testing and described in ASTM F2338.
The USP <1207> provides guidance on the integrity assurance of nonporous packages intended to hold sterile pharmaceutical products. The documents provides background instruction about leak and how to test for leaktightness. The documents gives guidance about the evaluation of the Maximum Allowable Leakage Limit (MALL), this strongly depends on process, package, testing procedures and it is evaluated and determined by the user.
Furthermore the documents gives guidance about the validation and the method development.
ASTM is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. Some 12,575 ASTM voluntary consensus standards operate globally.
Specifically the ASTM F2338 describes the procedure for leak testing of packages giving guidance about the approach for a method developement
Our partner Skytech Systems (I) Pvt. Ltd. will participate as exhibitor at Analytica Anacon India and India Lab Expo, if you want to discover more about QESSE products come at booth A41 in Hall 2. Read more…
Among the different techniques for Deterministic Leak Test procedures, one of the most interesting and effective is the HVLD High Voltage Leak Test. This method is known and applied for many years, at least from Read more…
The traditional methods Dye Ingress Test The most widely used in the past is certainly the Dye Ingress Test. This method is based on the concept, common also to other different fields of technology (e.g. Read more…
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