CCIT pharmaceutical packaging leak integrity testing machine

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Fife Vacuum Company's CCIT pharmaceutical packaging leak integrity testing machine

last updated：Oct 11, 2023

伯東本社

Industry-leading basic performance and track record.

The CCIT proposed by Faiver Vacuum Corporation is recently compliant with the revised General Chapter 1207 of the United States Pharmacopeia (USP). It is a quantitative technology that is less prone to human error. The testing method is non-destructive, reproducible, and has garnered attention. It accommodates various packaging forms such as vials, syringes, ampoules, drip packs, and blister packs. Regulatory revisions are expected due to new packaging forms and pharmaceutical formulations. Therefore, even higher testing standards for container closure systems will be required.

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basic information

The U.S. Food and Drug Administration (FDA) defines the container closure system as "the totality of components that together constitute the packaging that contains and protects the dosage form." The Container Closure Integrity Test (CCIT) is key to ensuring the safety of the product and the patient. Defects in the integrity of the container closure system can alter the active pharmaceutical ingredient (API) of the drug and potentially cause unexpected side effects, making it extremely harmful to patients.

Price range

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Delivery Time

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※Delivery times may vary depending on the model number and quantity. Please feel free to contact us.

Applications/Examples of results

【Usage】 • Vials • Syringes • Ampoules • IV bags • Blister packs etc.

Detailed information

• No special tracer gas is required. Instead, gas leaking from the headspace of the container is measured using a highly sensitive optical emission spectroscopy (OES) method. • High sensitivity - capable of detecting holes smaller than 1 micron. • Non-destructive gross and fine leak testing. • Compliant with 21 CFR part 11. • User restrictions, data tampering prevention features (DI), and test results and calibration reports in PDF format that strictly adhere to GMP. • Combination of automatic test sequences is possible (optional).
• Highest sensitivity helium mass spectrometry • Non-destructive gross and fine leak testing • Easy operation with one-touch helium filling module • User restrictions, data tampering prevention features (DI), and test results and calibration reports in PDF format compliant with GMP • Sniffer mode to identify leak locations
•Leak detection using the Mass Extraction method •Tracer gases such as helium are not required •Compatible with samples containing liquids

Line up（3）

Model number	overview
AMI1000	• No special tracer gas is required. Gas leaking from the headspace of the container is measured using a highly sensitive luminescence analysis method (OES). • High sensitivity - detects holes smaller than 1 micron order. • Non-destructive gross and fine leak testing. • Complies with 21 CFR part 11. • User restrictions, data tampering prevention features (DI), and test results and calibration reports in PDF format that strictly adhere to GMP. • Combination of automatic test sequences is possible (optional).
ASM2000	• Highest sensitivity helium mass spectrometry. • Non-destructive gross and fine leak testing. • Easy operation with one-touch, helium filling module. • User restrictions, data tampering prevention features (DI), and test results and calibration reports in PDF format that strictly adhere to GMP. • Sniffer mode allows for pinpointing leak locations.
ATC ME2	• Detects leaks using the Mass Extraction method. • No tracer gases such as helium are required. • Compatible with samples containing liquids.