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Burst & Leak Testers
Medical Device and Packaging Testers
Burst, leak and flow testers form a key part of manufacturers' quality assurance equipment to establish and maintain the quality of both medical devices and their packaging. We supply a wide selection of testers to help you meet the (usually stringent) standards which govern the testing of sub-assemblies, products and packs in order to achieve the required quality levels.
From the very simple to the very sophisticated, using a variety of technologies (pressure decay, vacuum, burst, tracer gas etc.), our cost-effective machines will help ensure that you have all the necessary data to achieve the quality required by regulatory bodies and expected by your end users.
Our LPC testers for example can test both products and impermeable packs, detecting leaks, measuring flows and monitoring valve opening pressures as well as balloon inflation pressures. Pack strength testing is achieved through the "burst method" (equally applicable to catheters and inflation balloons) using internal pressurisation as detailed in several ASTM standards.
Integrity testing is equally important for pharmaceutical manufacturers who will be more specifically interested in tablet blister and sterile ampoule testers.
Device Testers
Leak and flow testers form an important part of the industry's quality assurance arsenal. Our well-engineered equipment is suited to every situation, from stand-alone machines to networked solutions, simple tooling to full automation for turn-key projects. Accurate and repeatable testing is achieved using pressure decay or mass flow technology, suitable for use on sub-assemblies or finished devices... Leak test machine read more...
Medical Pack Testers
Packaging forms an integral part of all sterile medical devices. CE technical files and FDA submissions both require testing to ISO 11607-1:2006 Packaging for terminally sterilized medical devices. Leak testing is used to assess the integrity of impermeable packs and burst testing is used with all types of packs to measure seal strength... Packaging testing read more...
Pharmaceutical Pack Testers
Whether you need to maintain product sterility or a low humidity atmosphere, we are able to support your production process. OptiVac will provide you with a simple “no electronics” and reliable QA method to test tablet blister packs, whilst, for sterile vials, a particular adaptation of the LPC 820 leak test computer will deliver accurate measurement of any leakages and full data handling. Pillow or pouch over packs can be tested using the vacuum test combined with the LPC 820 or OptiVac system... Closure testing equipment read more...
