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Pharma industry

Pharma industry

Integrity of vials, ampoules, syringes,...

Maintaining sterility is an absolute priority in the pharmaceutical industry. Container Closure Integrity Testing (CCIT) is a mandatory step when following Good Manufacturing Practices (GMP) before releasing a batch of medication. The traditional CCIT method, dye testing, has several major drawbacks:

These factors are becoming increasingly unacceptable for production sites, which seek to eliminate waste and optimize resources.

Additionally, the FDA (Food and Drug Administration) recommends prioritizing deterministic tests, such as those listed in USP 1207 (United States Pharmacopeia).

Our “F” range of instruments uses pressure decay and vacuum decay methods, which align with these recommendations.

They offer significant advantages:

These instruments also allow for greater precision, ensuring compliance with demanding standards such as ASTM F2338-09. Their ergonomic design provides effortless operation, enabling quick and easy loading/unloading—either one piece at a time or in batches of five.

Correlation with dye testing can be established using standard leaks. ASC Instrument specialists can advise on or even conduct such studies.

Integrity of sachets, pouches, bags, …

Flexible packaging is widely used to contain components, bulk materials, liquids, and medical devices such as catheters.

The integrity of these flexible enclosures is crucial, it must be preserved until the point of use. We have developed an efficient non-destructive test method, applicable to a wide range of packaging, from small sachets and stick packs just a few centimeters in size to large flexible enclosures like betabags. They are used right after the packaging process, but may also be used as verification at the point of use, prior to opening.

Our “S” range allows users to select the most suitable instrument for the dimensions of the product to be tested.