Ophthalmic products are sterile preparations that include contact lenses, specific surgical implants, eye gels, lotions, powders, parenteral medications, ophthalmic inserts, prefilled syringes, etc. These products are applied onto the exterior surface of the eye. Ophthalmic products are packaged by various pharmaceutical firms in various ways and in various materials. According to pharmaceutical production and packaging requirements, all ophthalmic products must pass a strict sterility test.
Plastic containers are used to package almost all commercially accessible ophthalmic products. Plastic bottles, which are mainly made of Low-Density Polyethylene (LDP), Polypropylene (PP), High-Density Polyethylene (HDPE), and other materials depending on the specific product demand, are the most widely used materials for packaging of ophthalmic products. These plastic packaging components, which include bottles, fittings, and closures, enjoy universal acceptability due to obvious advantages such as ease of use, reduced spillage, and little breakage. In the late 1940s, Alcon was the first business to produce these packaging components, known as "Drop-Trainers" for ophthalmic medications, and they quickly became the industry standard for packaging topical ophthalmic products.
VeriPac Vacuum Decay Technology
Vacuum decay is a testing process that has been validated over many years and has been improved by new technological advancements. The test method is straightforward in concept, and it tests container integrity using basic physical attributes. It includes drawing vacuum on a package inside a test chamber and checking for any degradation in the vacuum level, which would indicate a leak. It saves money by avoiding wasting product during a leak test, and many products provide a quick return on investment.
Leak testers from VeriPac attach to a test chamber that is specifically constructed to hold the package being evaluated. The package is then placed inside the vacuum-sealed test chamber. The test chamber is monitored for both the level of vacuum and the change in vacuum over a defined test time using single or dual vacuum transducer technology. The presence of leaks and faults within the package is indicated by variations in absolute and differential vacuum. A test's sensitivity is determined by the package design, the package test fixture, and crucial time and pressure test parameters. Manual or fully automated testing systems are available. For QA/QC statistical process control, this inspection method is appropriate for laboratory offline testing and production applications. The test cycle is quick, non-invasive, and non-destructive to both the product and the packaging.
The VeriPac 455 is a non-destructing and quantitative inspection device that enables the very sensitive identification of empty and pre-filtered syringes, liquid filled and freezed vials, as well as other forms of liquid filled packaging, without any preparation of the sample. The VeriPac 455 is adequate to the challenge of testing these types of products, which necessitates the highest level of sensitivity, reproducibility, and accuracy.
Benefits of VeriPac 455
- No sample preparation, non-destructive, and non-subjective
- Highest level of sensitivity, repeatability and accuracy
- Results have been shown to be superior to dye intrusion
- Deterministic, quantitative test method
- Supports zero-waste and sustainable packaging
- ASTM test method and FDA standard
- Capable of detecting leak rates as low as 0.01 cc/min