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Viral Penetration

Viral Penetration

The Viral Penetration test is a pass/fail test that evaluates the viral penetration resistance characteristics of personal protective equipment such as gowns, drapes and gloves. This test is required by AAMI PB70 guidance to determine the level of protection for gowns and drapes. The test is also required for 510(k) submissions to the FDA, as well as for protective equipment per national fire protection agency regulation. Additionally, this test has been used by textile manufacturers to qualify their product for sale as raw material to medical device manufacturers.

The Viral Penetration test is officially recognized by the FDA and is performed in compliance with ASTM F1671 and AAMI PB70 Nelson Laboratories staff assisted in the development of this test method and has more experience in Viral Penetration testing than any other company. We provide a one-stop shop for all PB70 testing.

Applicable Standards

  • ASTM F1671
  • ISO 16604
  • AAMI PB70
  • ASTM F2407
  • NFPA 1971
  • NFPA 1999
  • NFPA 1951

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT (days) Request Quote
VPT110 Viral Penetration, ASTM F1671 15 Add
VPT120 Viral Penetration, ISO 16604 15 Add
VPT701 Viral Penetration, ASTM F1671: Setup and preparation, per set Add
VPT702 Viral Penetration, ISO 16604: Setup and preparation (cutting) per set up to 32 Add
VPT705 Viral Penetration, ASTM F1671: Compatibility Test Add
VPT706 Viral Penetration, ISO 16604: Compatibility Test 17 Add
VPT110 - Viral Penetration, ASTM F1671
15 days
VPT120 - Viral Penetration, ISO 16604
15 days
VPT701 - Viral Penetration, ASTM F1671: Setup and preparation, per set
Standard TAT not available for this product
VPT702 - Viral Penetration, ISO 16604: Setup and preparation (cutting) per set up to 32
Standard TAT not available for this product
VPT705 - Viral Penetration, ASTM F1671: Compatibility Test
Standard TAT not available for this product
VPT706 - Viral Penetration, ISO 16604: Compatibility Test
17 days

Sample Specifications

VPT110: 32 specimens recommended for FDA Submission (ASTM F1671 requires minimum of 3 specimens); each specimen must be 3 x 3 inches (75 mm x 75 mm) minimum. Include 4 extra samples for setup.
VPT120: 32 specimens recommended for FDA Submission; each specimen must be 3 x 3 inches (75 mm x 75 mm) minimum. Include 4 extra samples for setup.

Study Outline

In this Viral Penetration test procedure, specimens are prepared by randomly cutting the test material into approximately 75 mm x 75 mm swatches. The swatches are conditioned at 21 ± 5°C and 30 – 80% relative humidity for at least 24 hours. Once conditioned, individual test specimens are loaded into the penetration test cell with the outside of the material facing the reservoir. The test cell reservoir is then filled with approximately 60 ml of the phiX174 bacteriophage suspension, maintained at a concentration of at least 1.0 x 108 plaque-forming units/ml, and allowed to sit for 5 minutes at atmospheric pressure.

After the initial 5 minutes, an external air source is connected to the test cell and a pressure of 2 pounds per square inch gauge (psig) is applied to the sample for 1 minute. After 1 minute of applied pressure, the pressure is released and the specimen then sits for an additional 54 minutes at atmospheric pressure.

Throughout the test, the surface of the specimen is observed for penetration. To further evaluate whether viral penetration occurred, at the end of the test, the surface of the test specimen is rinsed with a sterile assay fluid and collected. This assay fluid is plated using standard plaque assay techniques. The assay plates are then incubated for 6 – 18 hours. Specimens showing no plaques on any of the assay plates pass the test, while plates that exhibit plaque forming units fail.
 
The surface tension range for blood and body fluids is approximately 42 – 60 dynes/cm. To simulate the wetting characteristics the phiX174 bacteriophage, suspension is adjusted to the lower end of this range (42 ± 2 dynes/cm).