Sterile medical device packaging must maintain its integrity from manufacture through to the point of use. IETQAN evaluates seal strength, burst resistance, microbial barrier performance, and overall packaging integrity in full compliance with ISO 11607 and ASTM standards.
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Before your product can enter the market with a defined shelf life claim, you must demonstrate that the packaging system will maintain its sterile barrier throughout that period. IETQAN conducts Accelerated Aging Studies using the industry-recognised ASTM F1980 method, enabling you to establish validated shelf life data in a fraction of the time required by real-time testing alone.
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Ethylene oxide (EO) sterilization is widely used in medical device manufacturing, but residual EO and its by-product ethylene chlorohydrin (ECH) must be controlled to ensure patient safety. IETQAN’s Residual EO/ECH Analysis service confirms that residual levels fall within the limits defined by ISO 10993-7 and applicable regulatory standards.
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IETQAN provides heavy metal and elemental impurity testing for medical devices and pharmaceutical materials in compliance with ISO 10993-18, USP <232>, and USP <233>. Our analytical laboratory detects and quantifies regulated elements — including lead, cadmium, arsenic, and mercury — providing the documented evidence required for regulatory submission.
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Many medical devices — including catheters, gloves, and surgical instruments — incorporate lubricants during manufacturing. IETQAN’s Lubricant Concentration Testing service verifies that lubricant levels comply with your validated specifications.
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