Parenteral preparations are defined as solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, gels for injection and implants. They are sterile products intended to be administrated directly into human bodies. Parenteral drug products are expected to be free from microorganisms, pyrogenic substances as well as other visible particles. Contaminated parenteral drug products can cause serious health concerns to the patient. Hence, sterility assurance and package integrity testing are of paramount importance in parenteral drug manufacturing. Read on to know more about parenteral products package testing methods offered by PTI.
Parenteral products package testing methods:
1. Vacuum Decay technology
Vacuum Decay technology is a non-destructive Container Closure Integrity test method primarily used to detect leaks in package seals. Proven to be the most practical and sensitive vacuum-based leak test method, Vacuum Decay technology is capable of identifying leaks in sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. It provides reliable, accurate and repeatable test results that ensure deterministic package testing and leak detection. Vacuum Decay technology has established itself as a non-destructive alternative to traditional test methods like Water Bath and Dye Ingress, making it a practical solution for leak detection in the Pharmaceutical and Medical Device industry.
How does Vacuum Decay technology work?
The principle behind Vacuum Decay technology is simple and it challenges container integrity based on fundamental physical properties. The test begins by placing sample packages in a closely fitting evacuation test chamber, which is equipped with an external vacuum source. Based on the test sample and level of sensitivity required, a pre-determined vacuum level is chosen for the test. The next step involves evaluating the test chamber and test system dead space for a pre-determined period. Differential pressure transducers are used to monitor changes in vacuum levels for a specified period. A pressure increase beyond the predetermined pass/fail limit indicates container leakage.
Benefits of Vacuum Decay technology
- Non-destructive package inspection system
- Accurate and reliable results
- Definite pass/fail result based on quantitative test data
- Accommodates multiple packaging formats
- Eliminates destructive, subjective testing methods
- Effective in detecting even minute leaks
- ASTM Test Method F2338, FDA Consensus Standard and USP 1207 compliant
2. MicroCurrent HVLD Technology
PTI’s Microcurrent is patent-pending unique CCI technology that has revolutionized the conventional high voltage leak detection method. It is a non-invasive and deterministic container closure integrity testing method that is effective across all parenteral and biologic products including low conductivity liquids such as sterile water for injection. The Microcurrent HVLD test method is highly effective in detecting the presence and location of pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping and many other defects across applications like pre-filled syringes, vials, cartridges, ampoules, BFS, bottles and pouches. A unique mode of Microcurrent HVLD uses about 50% less voltage and reduces the exposure of product and environment to less than 5% of the voltage when compared to conventional HVLD solutions. The E-scan HVLD series is a leading solution of sturdy container closure integrity test equipment.
Benefits of MicroCurrent HVLD technology
- Non-destructive & requires no sample preparation
- Deterministic & non-invasive
- Highly effective across all parenteral products
- High levels of sensitivity, accuracy and reliability in results
- Offline and 100% online inspection at high production speeds
- Simplifies the inspection and validation process
- Referenced in Chapter USP 1207 Guidance for CCIT
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