การตรวจสอบรอยรั่วบรรจุภัณฑ์ Vacuum Decay Principle
การตรวจสอบรอยรั่วบรรจุภัณฑ์ Vacuum Decay Principle
เทคโนโลยี Vacuum Decay กล่าวโดยย่อก็คือ การตรวจสอบรอยรั่วบรรจุภัณฑ์โดยอาศัย การทำให้แรงดันรอบๆบรรจภัณฑ์น้อยกว่าแรงดันภายในบรรจุภัณฑ์นั่นเอง เมืออากาศภายในมีแรงดันมากกว่าอากาศภายนอก หากบรรจุภัณฑ์มีรอยรั่ว อากาศภายในก็จะพยายามไหลออกมาทางรอยรั่วนั่นเอง
The ability to detect leaks is necessary to ensure consistency and integrity of packages. It is also important to detect leaks and defects that are not visibly detectable. Package integrity testing using destructive inspection methods such as water bath, dye tests, peel and burst tests render ALL tested packages useless, both good and bad. These methods are time consuming and unreliable, producing results that are dependent on technique, sample preparation and operator variability. In addition, destructive methods generate significant product loss, waste and mess. Packages can be non-destructively evaluated using the VeriPac inspection method which is based on vacuum decay technology. Package types include filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials.
VeriPac's non-destructive technology is capable of detecting package leaks and invisible defects using an absolute or differential pressure transducer leak test system. Package leaks may appear as imperfections in the package components themselves or at the seal juncture between mated components.
Principles of Vacuum Decay, A Non-destructive inspection technology to verify container closure system integrity. By super-sensitive pressure differential transducer and and a know-how technology to create sample test chamber makes highly sensitive micro leak detection of empty & pre-filled syringes, liquid filled & lyophilized vials and other liquid filled packaging.
The VeriPac 455 can be incorporated into protocols at any point in the handling process as it is non-destructive, non-invasive and requires no sample preparation. Applications for this technology include stability studies, clinical trial studies, quality assurance testing and production statistical process control (SPC). The VeriPac 455 is capable of detecting as little as 0.05 cc/min. Results have proven to be superior and more reliable than the dye ingress test.
The VeriPac 455 core technology is based on the ASTM vacuum decay leak test method (F2338-09) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using VeriPac leak test instruments. The VeriPac 455 features patented dual vacuum transducer technology, PERMA-Vac, that offers increased test sensitivity and produces very consistent, reliable results. The VeriPac 455 also incorporates significant advances in internet connectivity and networking capabilities that facilitate remote operation, system monitoring and troubleshooting.
Benefits:
- Non-destructive, non-invasive, no sample preparation
- Defect detection down to 0.05 ccm
- Highest level of sensitivity, repeatability and accuracy
- Results proven superior to dye ingress
- Supports sustainable packaging initiatives due to zero waste
- ASTM test method and FDA standard
- Test systems can be designed for manual or automatic operation. This inspection method is suitable for laboratory offline testing and QA/QC statistical process control.
Inspection Criteria:
- Measures seal integrity of entire container or package
- Measures and verifies container closure system integrity
- Tests for gas leaks for dry products (lyophilized vials, powder filled)
- Tests for liquid leaks (liquid filled vials, pre-filled syringes)
