In the pharmaceutical industry, trust is not just a value—it is an absolute necessity. Patients, healthcare providers, and regulatory bodies rely on pharmaceutical manufacturers to deliver products that are safe, effective, and free from contamination. Any compromise in the integrity of pharmaceutical packaging can lead to serious consequences, including drug contamination, reduced efficacy, and potential harm to patients.
Building trust in pharmaceutical products begins with rigorous quality control testing, which ensures that every package maintains its integrity from production to patient use. By implementing advanced life science testing services, manufacturers can confidently verify the safety of their packaging, meet stringent regulatory requirements, and uphold their commitment to patient health.
PTI offers a suite of highly advanced package integrity testing methods that ensure pharmaceutical packaging remains leak-free and intact. These non-destructive technologies—such as Vacuum Decay, MicroCurrent HVLD, Helium and Airborne Ultrasound—provide accurate, repeatable, and reliable results, allowing manufacturers to eliminate defective packaging before it reaches the market.
How Does Rigorous Quality Control Testing Build Consumer Trust?
Trust in pharmaceutical products is built on three key pillars: safety, efficacy, and compliance. To achieve this, manufacturers must go beyond visual inspections and use of probabilistic methods and implement scientifically validated, high-precision testing methods that detect even the smallest packaging defects reliably.
- Ensuring Drug Safety: Pharmaceutical products must be free from microbial contamination, oxidation, or any exposure to environmental elements. A compromised package can introduce external agents that degrade the medication, leading to potential health risks.
- Maintaining Drug Efficacy: Many drugs are sensitive to changes in moisture, oxygen, or pressure. Even a microscopic leak in a container can alter a drug’s chemical stability, making it less effective or even harmful.
- Meeting Regulatory Standards: Global regulatory agencies, including the FDA, EMA, and USP, require pharmaceutical companies to demonstrate container closure integrity using scientifically validated testing methods. Advanced CCIT solutions provide objective, quantifiable results that help manufacturers meet these compliance standards.
Quality Control Testing Methods Offered by PTI
1. Vacuum Decay Technology
Vacuum Decay testing is one of the most widely recognized and FDA-approved methods for detecting leaks in pharmaceutical packaging. It is an ASTM F2338 standard test method that has been proven effective in ensuring container closure integrity for vials, syringes, and other rigid packaging formats. This non-destructive test method works by placing a sealed pharmaceutical container inside a vacuum chamber. Once the chamber is evacuated, highly sensitive sensors monitor for changes in pressure over a fixed period. If a leak is present, air or gas from inside the package will escape into the chamber, causing a detectable shift in pressure.
PTI’s VeriPac Series utilizes this advanced technology to provide fast, reliable, and repeatable results, making it an ideal solution for in-line production testing as well as laboratory-based package integrity verification.
2. MicroCurrent HVLD Technology
MicroCurrent High Voltage Leak Detection (HVLD) is an advanced Container Closure Integrity testing (CCIT) method designed specifically for liquid-filled pharmaceutical containers, such as pre-filled syringes, vials, ampoules, cartridges, and blow-fill-seal (BFS) bottles. Unlike conventional HVLD methods that expose products to high electrical energy, MicroCurrent HVLD uses an ultra-low voltage approach to ensure product safety while maintaining high sensitivity.
This technique works by applying an electric current to the sealed container. If the container is intact, the current flows uniformly through the liquid inside. However, if a defect or microscopic crack is present, the electrical path is disrupted, allowing the system to detect and pinpoint the exact location of the leak.
MicroCurrent HVLD is particularly beneficial for testing low-conductivity liquids, such as sterile Water for Injection (WFI) and protein-based biologic formulations. Unlike traditional HVLD methods, which can damage sensitive biologics, this innovative technology significantly reduces electrical exposure—using up to 50% less voltage and limiting product interaction to less than 5% of conventional HVLD solutions.
3. Airborne Ultrasound Technology
For pharmaceutical products packaged in flexible materials, such as pouches, blister packs, and medical device packaging, seal integrity is a critical quality control factor. Even minor defects in a seal can allow contaminants to enter, potentially compromising product sterility and stability. Airborne Ultrasound technology is an advanced, non-destructive testing method that ensures the highest levels of seal quality assurance.
This FDA-recognized and ASTM F3004 standardized method works by transmitting high-frequency ultrasound waves through the package seal. As the waves travel through the material, any variations in the signal indicate voids, weak seals, or leaks. A properly formed seal produces consistent ultrasound reflections, whereas a defective seal disrupts the wave pattern, making it easily identifiable.
Ensuring package integrity in pharmaceuticals goes beyond compliance—it safeguards patients and builds trust. With advanced drugs and biologics on the rise, precise, non-destructive testing is essential. PTI’s solutions—Vacuum Decay, MicroCurrent HVLD, and Airborne Ultrasound—help manufacturers maintain quality, prevent defects, and meet global standards. Investing in reliable testing minimizes recalls and reinforces consumer confidence, making integrity a true commitment to excellence.