The dye ingress test method is a routine test for container closures attached to parenteral drugs and large molecule drugs. Traditionally, this method uses ten test samples and three positive controls. During this testing, the test samples are place in a vacuum chamber and pressurized with dye. Three vials are punctured to allow dye to enter the vial for this testing and visual comparison purposes—these punctured vials are named the “positive controls”. Samples that show dye in the vials do not pass the test, including the positive controls. This method is used to test for Container Closure Integrity (CCI); but with high risk parenteral applications and large molecule drugs, this method is not sufficient. There’s a need of urgency to solve the CCI test methods for large molecule drugs or parenteral drugs. Altering the methods of testing for container closures will only secure the patient’s safety.
The dye ingress test method is not a suitable approach for patients safety. It is inevitable that all containers leak. Dye could get in and damage any product in the container unknowingly. This dye is not safe for high risk CCI applications due to caution for the patients safety.
“There is no global standard for the dye ingress test method”. Meaning, all inspectors could have different expectations and approaches with this method. Dye ingress method is known to have played a role with visual inspection tests. Visual inspectors are subjected towards approving or recalling an entire product due to the container closure and results from the dye ingress test.
Scientists are still determining what the best alternatives to the dye ingress method. Currently, scientists have defined appropriate norms for CCI testing—in USP<1207>, that will lead to improving with all visual inspections of products as well as noting when a product should be rejected
The Identifier Software will help keep track and identify all qualifications for visual inspections and following data integrity—supporting USP <790> and <1790>. By storing data and qualifications, we can help secure patient safety with parenteral drugs.