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Microbial Ingress

Microbial Ingress

The Microbial Ingress test evaluates the microbial barrier performance of needle-free injection sites on intravascular (IV) administration sets. Needle-free devices allow bi-directional fluid flow to facilitate Intravascular Therapies. Such devices may become contaminated on their external surfaces under normal clinical use and require disinfection of the injection site prior to use.

This test is conducted to meet the criteria established in the FDA Guidance Document for 510(k) submission of IV administration sets. Nelson Laboratories is very familiar and proficient at this unique form of testing, which is not offered by many other microbiology labs.

Applicable Standards

  • FDA Guidance Document for 510(k) submission of IV administration sets

Test Options

Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

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PMI110 Microbial Ingress for IV Admin Products: Study Fee Add
PMI110 - Microbial Ingress for IV Admin Products: Study Fee

Study Outline

The Microbial Ingress test protocol calls for the evaluation of the microbial barrier performance of products under a simulated use model. The test should simulate extreme-use conditions over a period of time. All fluids from simulated administration(s) will be captured, filtered and incubated in order to detect the presence of microorganisms and measure the ability of the needle-free device to prohibit their transfer into the fluid path.

Note: It is the responsibility of the client to determine appropriate testing parameters for 510(k) submission requirements. Client specifications should include: number of devices, number of activations, types of organisms, type of disinfectant, disinfectant application technique and the period of time over which the test occurs.

Testing is performed in a sterile Laminar flow hood (class 100 clean bench). Test samples will be set up in a way to avoid cross-contamination from one sample to another. Organisms chosen (typically 2 gram negative and 2 gram positive, chosen by the client) will be adjusted to approximately 105 colony-forming units (CFU)/ml in soy casein digest broth (SCDB) before testing begins.

Samples will be inoculated with 0.01 ml of the organism to reach an approximate inoculum level of 103 CFU on the tops of the devices. Following the surface contamination, the disinfectant will be applied to the tops of the devices in the manner prescribed. Disinfection will be followed by an activation of the needleless access device with an empty, sterile, syringe. This cycle (inoculation, disinfection, activation) will be repeated as often as needed over a course of time determined by the client.

After an appropriate number of cycles have been run on the devices, the devices will be activated with a 10 ml syringe filled with sterile saline. The sterile saline will be flushed through the device and collected within a sterile filter funnel. After filtering the contents of the syringe through a 0.45 mm filter, the filters will be plated and incubated for an appropriate amount of time. After incubation, colonies found on the filters will be counted and reported.
Positive and negative controls are tested concurrently with the test samples. Positive controls are challenged in the same manner as the samples, but are not disinfected. Negative controls are not challenged, but are tested in the same manner as the test samples. The challenge concentration is determined by a titer performed concurrently with the test.

The number of devices and amount of disinfectant will depend on test specifications requested. Contact us for additional guidance.

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