Frequently Asked Questions (FAQs)
What is Clyraguard Personal Protection Spray?
Clyraguard Personal Protection Spray is a disinfectant and germicide intended to clean and decontaminate noncritical medical devices such as personal protective equipment (PPE).
Clyraguard is a medical device class I (exempt) registered with the FDA and its base formula is an FDA cleared solution based on a copper-iodine complex platform (K181428, Class II medical device).
What is the copper-iodine complex technology behind Clyraguard and how this helps to reduce bacteria, virus and fungus?
The powerful yet safe iodine-copper technology of Clyraguard allows the release of a controlled amount of free iodine, which along with copper ions produce a synergistic effect to decontaminate PPE.
The antimicrobial properties of this copper-iodine technology have been assessed against bacterial pathogens commonly associated with Hospital Acquired Infections (HAIs) (ESKAPE pathogens), including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus
faecalis (VRE), and Pseudomonas aeruginosa. GLP testing have shown that Clyraguard base formula can reduce the bacterial and fungal burden up to 99.999% (5 log reduction) for up to 3 days1.
The product has also been tested against the SARS-CoV-2 virus (that causes Covid 19) and totally inactivates the virus within 30 minutes, thus providing additional protection for a mask or other PPE between any resterilization and re use2.
Iodine is an essential trace element for human beings and also a very well established antiseptic that has been in use for more than 150 years. It is one of the most widely accepted antimicrobials in the world with broad spectrum of antimicrobial activity, rapidly inhibiting bacteria, yeasts, molds, protozoa and viruses and no known acquired resistance. Its mechanism of action works in two ways:
(1) Penetration into the cell wall of the microorganism, causing blocking of the hydrogen bond which results in damage to the phospholipid cell membrane;
(2) Damage and denaturing of the proteins,nucleotides and fatty acids, leading to rapid cell death by binding to amine and sulphydryl groups3. Additionally, copper also is an essential trace element for human beings, which in controlled doses has important antimicrobial activity4,5.
What are the benefits of Clyraguard?
- Extremely High Efficacy 99.999% kill rate against bacteria, fungi and viruses
- Safe on skin / Non-irritating / Non-sensitizing / Non-toxic/pH friendly
- Sustained Activity: 10 min to 3+ days
- No Known Microbial Resistance
- Clear / Colorless / Odorless
- No Rinsing, Mixing or Dilution Required
- Environmentally Friendly
How to use Clyraguard?
Apply Clyraguard Personal Protection Spray directly onto mask or PPE until full coverage is achieved.No rinsing or dilution required. Close eyes if spraying on mask in situ.
How much should be used each application?
Each Personal Protection Equipment (PPE) has different surface area, therefore it is recommended to spray Clyraguard until full coverage of the surface. For example, for standard masks an average of 3-4 sprays up to 6 times per day will allow for > 30 days use6
How many applications are recommended daily?
Clyraguard has shown sustained antimicrobial activity (bacteria and fungi), however, depending on the PPE and the protocol for hygiene within the hospital setting for SARS-CoV-2 it is recommended that PPE be resprayed between exposure to new environments and patients or every 2-3 hours.
How long is it necessary to wait after application on mask or PPE?
There is not a safety or performance reason to wait to use your mask and PPE after Clyraguard application. The product will start protecting immediately and has a significant effect on the virus (log 2 reduction) but will reach total deactivation of the virus at 30 minutes.
Are there any safety concerns for Clyraguard to be in contact with skin?
The product is safe for skin and non intact skin (wounds, abraded skin, etc.) and has been evaluated for biocompatibility compliance (ISO 10993), including: cytotoxicity assay (ISO 10993-5:2009)7,sensitization test (ISO 10993-10:2010)8
, direct primary skin irritation test (ISO 10993-10:2010)9,material medicated pyrogenicity10, chemical characterization11, toxicological risk assessment for
systemic toxicity12 and stability testing (stable in composition, appearance, pH and self-sterile capacity (microbiological evaluation) for 2+ years, when stored unopened at ambient temperature,in accordance with the manufacturer’s recommendations13, 14).
Does Clyraguard have any warning or contraindication?
- For external use only.
- Not for injection or ophthalmic use.
- If you have a known sensitivity to iodine do not use product.
Does Clyraguard require any special handling, storage or disposal requirement?
Handling: safe for skin. Non-irritating, non-toxic, and non-sensitizing. No special handling precautions required.
Storage Conditions: Store at 15 – 30 °C (59-86 °F). Avoid excessive heat.
Disposal: No special disposal considerations are required.
What is the shelf life of Clyraguard?
Clyraguard can be stored at room temperature for two years (shelf life).
What is the package configuration?
Clyraguard is currently available in 2oz, 4 oz and 8 oz spray bottles (12 per case) as well as 1 gallon refill containers and 55 bulk gallon drums plus 330 gallon bulk totes. (Some items are special order only)
Do you have more production information?
For more information on Clyraguard, please see the product datasheet page.
1. GLP Time Kill Study. Nelson Laboratories. Study Numbers: 913680-S01 (Bacteria) and 1012993-S01(Fungus). 2016-2018.
2. In vitro efficacy testing of Clyra Irrigation Solution for Coronavirus (Covid-19) inactivation. SLP-0401-0003.Galveston National Laboratory Preclinical Studies Core. The University of Texas Medical Branch.
3. Cooper RA. Iodine revisited. Int Wound J 2007; 00:1–4. DOI: 10.1111/j.1742-481X.2007.00314.x
4. Carolina Falcón García, Martin Kretschmer, Carlos N. Lozano-Andrade, Markus Schönleitner, Anna Dragoŝ, Ákos T. Kovács and Oliver Lieleg. Metal ions weaken the hydrophobicity and antibiotic resistance of Bacillus subtilis NCIB 3610 biofilms. npj Biofilms Microbiomes 6, 1 (2020). https://doi.org/10.1038/s41522-019-0111-8.
5. Jonathan Baker, Sutthirat Sitthisak, Mrittika Sengupta, Miranda Johnson, R. K. Jayaswal, and Julie A.
Morrissey. Copper Stress Induces a Global Stress Response in Staphylococcus aureus and Represses sae and agr Expression and Biofilm Formation. Applied and Environmental Microbiology, 2010, p. 150–160.
6. Memo: Duration of Clyraguard 4 oz spray bottle based on the daily number of sprays. Dermazone Solution,Inc.
7. GLP Cytotoxicity by Agar Overlay. Nelson Laboratories. Report number: 1012989-S01. 2018.
8. GLP Guinea Pig Maximization Sensitization Test (Method for Liquid Test Article). Nelson Laboratories. Test code: 900854.1. Report Number: 122860. 2018.
9. GLP Direct Primary Skin Irritation Test - ISO Abraded Method. Nelson Laboratories. Report: 19-00374-G1.Report Number: NL# 1144568. 2019.
10. GLP Materials Mediated Rabbit Pyrogen (No Extraction). Nelson Laboratories. Test code: 900770.3. Report Number: 118088. 2018.
11. Ion concentration measurements for iodine, copper, potassium and sulfur using spectroscopy techniques (ICP-OES, ICP-MS). Galbraith Laboratories. 2018-2019.
12. Toxicological Risk Assessment (Chronic and sub-chronic systemic toxicity prolonged contact >24 hours < 30days). Nelson Laboratories. Project numbers: SC19011-DER01 and SC19011-DER01.1.
13. Stability studies (3 independent batches). BioScreen Testing Services. Project numbers: 1050481, 1082983,1082956. 2018-2019.
14. Antimicrobial Effectiveness Test (AET) (USP<51>). KLM Labs.