เครื่องทดสอบ ความสมบูรณ์ของการปิดผนึกบรรจุภัณฑ์ ประเภท Vials, Ampoules และ Syringes โดยใช้เทคโนโลยี Vacuum Decay

Vials, Ampoules & Syringes Container Closure Integrity Testing (CCIT)

Container closure integrity of parenteral products is essential to protect the product through the entire lifecycle until patient delivery. Our non-destructive inspection technologies verify container closure system integrity with deterministic quantitative test methods for vials, ampoules, syringes, cartridges and auto-injectors.

Container Closure Integrity of Parenteral Products

The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.

Parenteral products are usually packaged in several packaging formats. Most common are the following formats - Liquid-filled containers such as vials, ampoules, syringes, BFS and autoinjectors, and also containers filled with lyophilized product.

Any breach in the package can cause product deterioration from microbial contamination, exposure to gases, water vapor and loss of solvent. Therefore, container closure integrity is an essential stage in the lifecycle of a sterile drug product. Container closure integrity defects can be hazardous to the patients. Life-saving drugs can lose their efficacy or lead to fatal side effects. CCI defects can result in oxidation and have a significant impact on drug’s effectiveness and shelf-life.
 
Container Closure Integrity Testing Methods

The selection of the appropriate container closure integrity testing (CCIT) method depends on the requirements and purpose of the test. The factors considered while deciding the appropriate CCI test method include sensitivity and reliability of the test method, material of the primary package and inline versus offline testing requirement. Appropriate CCI test methods are able to detect breaches prior to product contamination and ensure patient safety. Moreover, it reduces the risk of catastrophic defects and product recalls.

VeriPac Vacuum Decay Technology

    ASTM Test Method F2338 and FDA Consensus Standard
    Defect detection down to 0.002 cc/min.
    Measures seal integrity of the entire container or package
    Tests for gas leaks for dry products (lyophilized vials, powder-filled)
    Tests for gas leaks for dry products (lyophilized vials, powder-filled)

Our technologies conform to ASTM and other regulatory standards.

Packaging Technologies & Inspection

We offers inspection systems for package leak testing, seal integrity and container closure integrity testing (CCIT). Our technologies exclude subjectivity from package testing, and use test methods that conform to ASTM standards. We's inspection technologies are deterministic test methods that produce quantitative test result data. We specialize in offering the entire solution including test method development and equipment validation.