Medical Device Package Testing
Besides its strengths in biological and chemical testing for pharmaceutical and medical device clients, Microtest rounds out its services offering with medical device package testing. It’s all part of the scope that makes Microtest your ideal single source for laboratory testing.
Materials for all package validation and integrity tests are quality-controlled via our extensive Good Manufacturing Practices (GMP) program. Tests are performed by trained, experienced package integrity technicians. Reporting time for the tests below is 1 week. Call Microtest for details on how to submit samples, and for advice on which package validation test best suits your particular product.
Our wide range of medical device package testing includes the following fast, reliable, expertly administered tests:
Peel Strength Test
This test measures the seal strength of flexible barrier materials, with procedures recognized by the American Society for Testing and Materials (ASTM). Peel strength testing utilizes a force gauge calibrated for 0 to 50 pounds, oriented at a 90 degree angle to the sample. The test measures and records the mean peel strength — of a sample area 1 inch wide by 3 inches long, clean-cut at a right angle to the seal — in pounds per square inch, with standard deviation.
This test measures package seal strength of items such as spunbonded olefin (Tyvek) pouches and lid trays. Air pressure on the seal is increased until the material separates; the highest pressure attained before bursting is noted. Burst testing determines the average burst pressure in force per unit area of a given package design. The test measures and records the mean burst pressure in inches of water, with standard deviation.
Methylene Blue Dye Test
This testing provides clearly distinguished visual evidence of package integrity, using methods specified by the U.S. Department of Health and Human Services (DHHS). In an immersion test, a sealed sample package is fully submerged in dye liquid, and then inspected for dye that has made ingress into the package. Or, in a bleed/channel test, dye is poured into a sample pouch or package; the package exterior is then examined for leaks or channels.
This testing measures the resistance of a package seal to internal pressurization. In a pass/fail creep test, the technician observes whether, on a pressurized package sample, seal edges begin separating or creeping apart. In a creep-to-failure test, the technician times and records the interval from when seal separation begins to when the seal ruptures definitively.