Why Do Manufacturers Choose Non-destructive Package Integrity Testing Methods?
Medical packaging growth has steadily accelerated in the United States. Stricter infection control standards, an aging population requiring more medical services, and more convenient and flexible package designs are all driving growth. Companies are looking for ways to improve their processes while maintaining costs and meeting the growing demand as the number of medical products packaged grows. This expansion emphasizes the importance of companies developing quality manufacturing practices. These practices can assist the company in ensuring the integrity of their packages.
Package integrity is the unimpaired physical condition of a final package. It basically means that a package meets the minimum physical properties and seal quality requirements. Package integrity testing ensures that the sterility of a package is maintained. It is an indicator of its sterile barrier.
Package quality has traditionally been assessed using probabilistic and destructive container closure integrity test (CCIT) techniques such as water bath, dye, and microbial ingress tests. Due to several factors, these tests have limited usefulness and dependability. The subjectivity of the results, the lack of uniformity, and the test operator’s lack of control over certain aspects of the test procedure are three main issues. Additionally, there is a lack of industry standards in these test procedures, as various sites employ various chemistries, cycle periods, and test parameters to provide test results.
On the other hand, non-destructive leak testing techniques including headspace analysis, vacuum decay, and high-voltage leak detection (HVLD) are based on phenomena that proceed in a predictable sequence. Physicochemical technologies that are simple to regulate and monitor are used to quantify leakage, producing quantifiable, objective data.
Benefits of non-destructive package integrity testing
1. Packaging Validation and Cost Effective Solutions
Validating packaging is essential to getting high-quality pharmaceutical products on the market. Along with choosing the proper package material, design, and qualifying equipment, it is essential to validate the sealing process and run sample tests. Non-destructive package leak testing employing the vacuum decay testing method provides trustworthy package validation. Moreover, packages can be returned to production once the test is complete, thereby reducing waste.
2. Data Is Easier to Interpret
Numerous destructive testing techniques have been shown to be inconsistent, unreliable, and frequently challenging for the operator to use in a unified environment. Due to the damaged or lost tested product, it is difficult to interpret the data. Additionally, the corporation may never be certain of the quality of the packages and what changes must be made to the packing line due to the inaccuracy of the results. Employing non-destructive package leak testing technologies will reduce costs and maximum operation time.
3. Save Costly Product
It is against the company’s best interests to fill a flawed container with expensive product only to discover later that the package was improperly sealed. Non-destructive package leak testing can streamline the testing process and prevent costly brand damage by evaluating packing materials in addition to the finished package.
The primary goal of any manufacturer would be to be sure that their products reach the consumer or patient in perfect condition without any damage. Today, the market offers a complete range of non-destructive package integrity testing solutions. Depending upon the type of packaging material used and test sensitivity required, they can choose the most appropriate solution.
