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The Environmental Protection Agency (EPA) engulfs its organization with quality laboratories and research centers. Gibraltar Laboratories, Inc exemplifies this standard. A leading provider of services related to disinfection, sanitization and sterilization regulated by the EPA, Gibraltar has 40 years of expertise and experience. In 1988, Gibraltar was recognized by the EPA as the second lab approved to test disinfectants against HIV-1 [AIDS]. Further, in 1992, Gibraltar became the first and, still, only lab approved by the EPA to test agents against human Hepatitis B Virus using its exclusive in vivo Chimpanzee model.
Today, our state of the art microbiology and chemistry laboratories offer clients valuable, rapid and reliable testing in order to substantiate claims of products. The testing of disinfectants ranging from limited efficacy to general or broad spectrum, as well as hospital or medical environments is routinely performed under the supervision of Ph.D or master level scientists. Depending on the product’s target of disinfection, sporicidals, fungicides, virucides or tuberculocides, the EPA determines the specific pass/fail criteria to be met such as the lot quantity to test, product age, organisms to challenge against, product concentration and, in some cases, contact time.
The test methods are provided by the EPA and require the use of methods as per the AOAC (Association of Official Analytical Chemists). These methods of testing include UDT (Use Dilution Test) and/or GST (Germicidal Spray Test). One deciding factor concerning which method to use depends on whether or not the product is intended for use as a spray. If so, the AOAC Germicidal Spray Test must be employed. Other supplemental claims added to the disinfectant product can also be tested as per the AOAC methods mentioned.
Gibraltar Laboratories also provides independent laboratory testing of food and non-food contact sanitizers as per the appropriate EPA guidance requirements.
Our routine performance of this testing allows for immediate scheduling and rapid turnaround times.
A more detailed listing of our testing services is found in the table below:
| Pertaining to the microbiology testing, antimicrobial product performance requirements are found in 40 CFR: Protection of the Environment Subpart E—Product Performance§ 158.400 Product performance data requirements table. |
Test |
Turnaround time |
Lots required |
EPA DIS/TSS-4 FOOD CONTACT SANITIZER TEST
Testing is performed per the AOAC method (AOAC Germicidal and Detergent Sanitizers) on 3 separate lots, one of which must be > 60 days old, against both Escherichia coli and Staphylococcus aureus. Acceptable results must demonstrate a 99.999% reduction in the number of test microorganisms within 30 seconds. |
5-7 Days |
3 Lots |
EPA HARD SURFACE MILDEW FUNGISTATIC TEST |
14 Days |
2 Lots, 3 Concentrations |
EPA DIS/TSS-1 DISINFECTANTS (GENERAL OR BROAD SPECTRUM EFFICACY)
Testing is performed per the AOAC UDT/GST method (DIS/TSS-1). Sixty carriers are required on 3 separate lots, one of which must be > 60 days old against Salmonella choleraesuis AND Staphylococcus aureus. Killing of 59 out of 60 carriers is required (total carriers = 360). |
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EPA DIS/TSS-1 DISINFECTANTS (HOSPITAL OR MEDICAL ENVIRONMENT EFFICACY)
Testing is performed per the AOAC UDT/GST method (DIS/TSS-1). Sixty carriers are required on 3 separate lots, one of which must be > 60 days old against Pseudomonas aeruginosa, Salmonella choleraesuis and Staphylococcus aureus. Killing of 59 out of 60 carriers is required (total carriers = 540). |
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EPA DIS/TSS-1 DISINFECTANTS (LIMITED EFFICACY)
Testing is performed per the AOAC UDT/GST method (DIS/TSS-1). Sixty carriers are required on 3 separate lots, one of which must be > 60 days old against Salmonella choleraesuis OR Staphylococcus aureus. Killing of 59 out of 60 carriers is required (total carriers = 180). |
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EPA (DIS/TSS-4 and DIS/TSS-5) FOOD CONTACT SANITIZERS (FOR HALIDE AND OTHER CHEMICAL PRODUCTS)
Testing is performed per the AOAC method (DIS/TSS-4 and DIS/TSS-5) (Available Chlorine Germicidal Equivalent Concentration method) on 3 separate lots, one of which must be > 60 days old, against Salmonella typhi. Test results must show product concentrations equivalent to 50, 100 and 200 ppm available chlorine. |
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EPA DIS/TSS-6 FUNGICIDES (PATHOGENIC FUNGI)
Testing is performed per the AOAC fungicidal method (DIS/TSS-6). Two separate lots are tested against Trichophyton mentagrophytes in a suspension test. Killing of all fungal spores in 10 minutes is required. |
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EPA DIS/TSS-10 NON-FOOD CONTACT SANITIZERS
Testing is performed per EPA Guidance (DIS/TSS-10). Three lots are required, one of which must be > 60 days old. Testing is performed against Staphylococcus aureus and Klebsiella pneumoniae containing 5% organic load. Enterobacter aerogenes may be substituted for Klebsiella pneumoniae. The results must show a reduction of at least 99.9% in the number of each test microorganism over the parallel control count within 5 minutes. |
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EPA DIS/TSS-9 SPORICIDAL CLAIMS
Testing is performed per the AOAC sporocidal method (DIS/TSS-9). Sixty carriers representing each of two carrier types (porcelain cylinders and silk suture loops) are required to be tested against Bacillus subtilis and Clostridium sporogenes on 3 separate lots, one of which must be > 60 days old. Killing of all 720 carriers is required. |
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EPA SUPPLEMENTAL ORGANISMS
Testing is performed per the AOAC UDT/GST method. Ten carriers are required on 2 separate lots against each supplemental organism. Killing of 10 out of 10 carriers is required (total carriers = 20). |
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EPA DIS/TSS-6 TUBERCULOCIDES
Testing is performed per the AOAC tuberculocidal method (DIS/TSS-6). Ten carriers are tested against each of 2 separate lots against Mycobacterium tuberculosis var. bovis. Killing of all carriers as well as no growth in any of the inoculate tubes of two additional media, is required. |
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EPA DIS/TSS-7 VIRUCIDES
Testing is performed per EPA Guidance (DIS/TSS-7). Two separate lots are tested. Inactivation of virus must be demonstrated at all dilutions when no cytotoxicity is observed or at all dilutions above the cytotoxic level when it is observed. The data must demonstrate a 3 log reduction in viral titer for both lots. |
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Our chemistry laboratory certifies the potency, stability and analytical enforcement method of the agent being registered as in 830 series Subpart D—Product Chemistry§ 158.300 below. |
Test |
Turnaround time |
Lots required |
EPA Product Properties
Group A — Product Identity, Composition, and Analysis Test Guidelines
830.1000 - Background for Product Properties Test Guidelines (March 1998) (PDF) (23 pp, 65K)
830.1550 - Product Identity and Composition (August 1996) (PDF) (5 pp, 12K)
830.1600 - Description of Materials Used to Produce the Product (August 1996) (PDF) (4 pp, 10K)
830.1620 - Description of Production Process (August 1996) (PDF) (4 pp, 10K)
830.1650 - Description of Formulation Process (August 1996) (PDF) (4 pp, 8K)
830.1670 - Discussion of Formation of Impurities (August 1996) (PDF) (4 pp, 11K)
830.1700 - Preliminary Analysis (August 1996) (PDF) (5 pp, 13K)
830.1750 - Certified Limits (August 1996) (PDF) (5 pp, 8K)
830.1800 - Enforcement Analytical Method (August 1996) (PDF) (3 pp, 8K)
830.1900 - Submittal of Samples (November 2008) (PDF) (3 pp, 11K)
Group B — Physical/Chemical Properties Test Guidelines
830.6302 - Color (August 1996) (PDF) (4 pp, 9K)
830.6303 - Physical State (August 1996) (PDF) (3 pp, 9K)
830.6304 - Odor (August 1996) (PDF) (3 pp, 12K)
830.6313 - Stability to Normal and Elevated Temperatures, Metals, and Metal Ions (August 1996) (PDF) (4 pp, 11K)
830.6314 - Oxidation/Reduction Chemical Incompatability (August 1996) (PDF) (4 pp, 13K)
830.6315 - Flammability (August 1996) (PDF) (5 pp, 13K)
830.6316 - Explodability (August 1996) (PDF) (5 pp, 13K)
830.6317 - Storage Stability (June 2002) (PDF) (4 pp, 16K)
830.6319 - Miscibility (August 1996) (PDF) (4 pp, 11K)
830.6320 - Corrosion Characteristics (August 1996) (PDF) (3 pp, 9K)
830.6321 - Dielectric Breakdown Voltage (August 1996) (PDF) (4 pp, 11K)
830.7000 - pH (August 1996) (PDF) (3 pp, 9K)
830.7050 - UV/Visible Absorption (August 1996) (PDF) (7 pp, 19K)
830.7100 - Viscosity (August 1996) (PDF) (7 pp, 23K)
830.7200 - Melting Point/Melting Range (March 1998) (PDF) (5 pp, 14K)
830.7220 - Boiling Point/Boiling Range (August 1996) (PDF) (13 pp, 66K)
830.7300 - Density/Relative Density/Bulk Density (June 2002) (PDF) (5 pp, 73K)
830.7370 - Dissociation Constants in Water (August 1996) (PDF) (8 pp, 23K)
830.7520 - Particle Size, Fiber Length, and Diameter Distribution (August 1996) (PDF) (13 pp, 97K)
830.7550 - Partition Coefficient (n-octanol/water), Shake Flask Method (August 1996) (PDF) (9 pp, 25K)
830.7560 - Partition Coefficient (n-octanol/water), Generator Column Method (August 1996) (PDF) (21 pp, 81K)
830.7570 - Partition Coefficient (n-octanol/water), Estimation by Liquid Chromatography (August 1996) (PDF) (11 pp, 35K)
830.7840 - Water Solubility: Column Elution Method; Shake Flask Method (March 1998) (PDF) (14 pp, 59K)
830.7860 - Water Solubility, Generator Column Method (March 1998) (PDF) (19 pp, 67K)
830.7950 - Vapor Pressure (August 1996) (PDF) (19 pp, 75K) |
3-4 Weeks |
Varies |
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