Jul 26, 2023 · Discover the importance of ampoule integrity in the pharmaceutical industry and learn step-by-step techniques for effective leak testing. Ensure the highest quality standards for pharmaceutical products with this comprehensive guide.

MicroCurrent HVLD technology detects leaks in nonporous, rigid, or flexible packaging such as ampoules that contains liquid products. This is a non-destructive High Voltage Leak Detection Technology that is highly effective across all parenteral …

Sep 30, 2016 · Container Closure Integrity Testing (CCIT) is an assay that evaluates the adequacy of container closure systems to maintain a sterile barrier against potential contaminants. Contaminants that could potentially cross a container closure barrier include microorganisms, reactive gases, and other substances (USP <1207>).

Products that are non-sterile have the potential to cause eye infections, which may be sight threatening. Recalling Firm: Merck Sharp & Dohme, West Point, PA, by letter June 7, 2010. Manufacturer: Merck & Company, Inc., West Point, PA. May have cracks which possibly could affect the drug's sterility.

Sepha has developed an ampoule leak test using vacuum or pressure decay to determine the integrity of glass ampoules. Ampoules need to be sealed completely, as any crack or defect can contaminate the sterile content inside.

Ampoule leak testing is a critical step in safeguarding product quality and consumer safety. By incorporating this essential quality control measure, manufacturers can ensure the integrity of their products, achieve regulatory compliance, and protect their brand reputation.

Laser-based leak detection involves using laser technology to identify changes in the seal integrity of ampoules. This method is highly precise and can detect leaks that are otherwise invisible to the naked eye. HVLD is a non-destructive testing method that is particularly effective for ampoules.

Apr 15, 2022 · HVLD is High Voltage Leak Detection, a sensitive, non-destructive technology to test container closure integrity in a variety of liquid-filled pharmaceutical and medical containers including glass vials and ampoules, IV-bags, Blow Fill …

PTI’s non-destructive inspection technologies verify container closure system integrity with deterministic quantitative test methods for vials, ampoules, syringes, cartridges and auto-injectors.

3.4 Seal Integrity Testing: Perform seal integrity testing on a sample of sealed ampoules to confirm that the seals are intact and meet the required standards. Common methods include vacuum leak testing, dye penetration tests, and visual inspection for defects.