Case Study: Listeria Control in a Ready-to-Eat Food Facility

Listeria monocytogenes' ability to survive in extreme conditions and form biofilms on various surfaces is a significant challenge for food safety. Last week, members of our Decontamination Service team helped a ready-to-eat food facility win the fight against l. monocytogenes. Treating an area just shy of 1,000,000 ft3, the service team completed the decontamination in just two days thanks to a very helpful in-house staff.  The first day consisted of sealing the space from the surrounding areas and sealing the ventilation system off at the roof.  Chlorine dioxide gas generators were setup with tubing run to various locations within the space to speed up the natural gas distribution.  50 biological indicators, all containing over a million bacterial spores, were placed at locations chosen by the facility's Quality Assurance and Food Safety personnel.  The decontamination itself took place on the second day, with gas concentrations being monitored continuously throughout the process from multiple locations throughout the space.  Once the final sampling location eclipsed the target dosage, the decontamination was deemed complete, and the gas was aerated from the facility.  Once the gas was removed and the area was safe for reentry, our team retrieved our supplies and packed them up.  Biological indicators were recovered and processed the next day to check for growth.  After 36 hours of incubation, all biological indicators were negative for growth, capping off a successful decontamination.

FDA November Discussion on Ethylene Oxide Replacement

Ethylene oxide (EtO) medical device sterilization has come under fire recently. Thirty-two people have filed claims against ethylene oxide sterilizing company Sterigenics, believing emissions has led to cause cancer in their bodies. The Chicago Sun Times reports:

“They’ve known for 34 years and they willfully pumped this out in our communities ...,” said Jeanne Hochhalter. "Nobody should have to go through anything like this." Hochhalter, who grew up in Burr Ridge, was one of 32 people who filed suit in the Circuit Court of Cook County this week against Sterigenics, which has a plant in Willowbrook where medical instruments are sterilized. In February, the Illinois Environmental Protection Agency shut down the facility after air quality monitoring recorded spikes of the gas ethylene oxide in surrounding neighborhoods (Esposito 2019).

Despite the environmental concern and public outrage, Sterigenics was allowed to reopen the Willowbrook facility in July.  However, the risk is still found in ethylene oxide sterilization.  In 2016, EPA published an updated Information on the Integrated Risk Information System determination which classified ethylene oxide to be a carcinogenic gas. Now, there is a consideration for an alternative sterilization method to be found, however due to the high level of use, it will be a great feat to switch, plus there is a risk of not having the proper ability to handle the workload either.

Ethylene oxide currently bears the brunt of the medical device sterilization in the country:

Currently, ethylene oxide is used to sterilize more than half of medical devices that need sterilization due to its chemical compatibility with many different device materials and ability to treat devices that are heat- or moisture-sensitive.

The second most common method to sterilize medical devices is radiation, such as gamma irradiation, X-ray radiation and electron beam radiation, which collectively represents about 45% of devices currently being sterilized.

The other common method currently is using pressurized steam, constituting about 5% of sterilization, according to FDA (BioMed Tech, Lim, 2019).

The FDA organized regulators from public health agencies, medical device manufacturers and expert physicians gathering Wednesday November 6th and Thursday November 7th at a two-day meeting to discuss how to address challenges with ethylene oxide. The FDA is looking to determine if there is a viable alternative for large scale medical device sterilization. There are many determinants, but one is if there is an elimination of ethylene oxide, what the FDA can do to prevent device shortages if reduced sterilization capabilities come to pass. New concerns present many challenges to an industry, but offer many opportunities for advancement in the possible use of even greater technology as well.

ClorDiSys Solutions Inc’s Director of Operations, Paul Lorcheim, is a panel member presenting an alternative sterilization technology method, chlorine dioxide.  Chlorine dioxide has long been determined safe for use on medical devices, particularly because it does not leave residues and it is an EPA registered sterilant. The FDA has the webcast day one of the meeting here, and day two is webcast here.

Sources

Esposito, Stefano. “Lawsuits Filed against Medical Supply Sterilization Plant Linked to

Increased Cancer Rates.” Chicago Sun-Times, Chicago Sun-Times, 20 Aug. 2019, https://chicago.suntimes.com/metro-state/2019/8/20/20814132/lawsuit-medical-supply-sterilization-company-linked-increased-cancer-rates-sterigenics-willowbrook.

Lim, D. (2019, November 6). 7 questions about ethylene oxide as FDA panel convenes.

Retrieved from https://www.medtechdive.com/news/7-questions-about-ethylene-oxide-as-fda-panel-convenes/566713/.

AALAS National Meeting 2019 Recap

Each fall since 1950, the American Association for Laboratory Animal Science (AALAS) has held its annual National Meeting. The AALAS National Meeting is the largest gathering in the world of professionals concerned with the production, care, and use of laboratory animals. The 2019 meeting was held at the Colorado Convention Center in Denver from October 13-17th. The spotlight forum was, "One Health–Connections Between Animal, Human, and Environmental Health. ClorDiSys Solutions exhibited at the National Meeting, one of our biggest shows of the year, in booth #209. The life sciences were really the second industry ClorDiSys introduced their products and services following our original focus on the pharmaceutical market.

We hosted a small dinner reception for AALAS attendees at the Denver Firefighters Museum after exhibit hall hours Tuesday evening. ClorDiSys provided a delicious BBQ dinner catered by Roaming Buffalo, and our guests had full access to all of the historic firehouse’s exhibits. From well-preserved lockers to restored antique firetrucks, even a 9/11 memorial, it really was a walk through history. The 2020 National Meeting is scheduled to take place in Charlotte, North Carolina, so we are open to suggestions for any local gems to take our group next year. Thank you to all who could join us!

ClorDiSys' Trip to Jamaica to Address Mold Prevention and Remediation

ClorDiSys Solutions' Director of Technology, Mark Czarneski, was recently down in Jamaica at the annual CanEx Jamaica Business Conference & Expo, which provided our company with the opportunity to explore the Caribbean agricultural market.  We learned from a variety of countries what their concerns are with regards to mold, mildew, and pathogens.  Throughout the growing cycle, and after, ClorDiSys has the ability to prevent and remediate these issues.  We are able to do so through unique and ever-changing approaches depending on the terrain, crop, and needs of the grower as well as the consumer's needs and requirements.  We currently have studies underway utilizing our ultraviolet light disinfection systems on a commercial farm in Montego Bay. We are both excited and optimistic about the successful results.

Mark Czarneski, Director of Techonology - ClorDiSys Solutions

ClorDiSys with Honorable Audley Shaw, the Minister of Industry, Commerce, Agriculture & Fisheries of Jamaica

ClorDiSys with Sabato Scofield Caesar, the Minister of Agriculture, Forestry, Fisheries, Rural Transformation, and Industry of St. Vincent and the Grenadines

Case Study: Airline and Retail Catering Kitchen

ClorDiSys Solutions has a wide range of experience within the food industry, having worked in Ready-to-Eat (RTE) facilities, dairy facilities, commercial kitchens, pet food facilities, and beverage plants. Biodecontamination can take place for a variety of applications. Recently, our Decontamination Services team performed a decontamination at a catering kitchen for airlines and airport retail locations.  The facility was fighting some positive environmental results and needed to regain control.  Due to the busy nature of their operation, limiting the stoppage of production was extremely important.  The chlorine dioxide gas process requires the environment to be fully sealed off from surrounding areas for safety.  The Cold Food Production Area was able to be sealed off quickly, while the Hot Food Kitchen required a much greater level of attention in order to properly seal it off from surrounding areas.  With this in mind, a two-tiered approach was taken in order to balance efficacy and treatment times.  Within the Cold Food Production Area, chlorine dioxide gas was utilized to provide a 6-log sterilization level kill of all surfaces within the space.  The Hot Food Kitchen would sanitized by fogging the area with a liquid chlorine dioxide solution.  This process does not require as tight of a seal, in turn requiring less set-up time.  This allowed both areas to be treated within the allotted downtime, while still providing an adequate level of treatment.  Environmental monitoring results taken after the treatment came back negative, and the chlorine dioxide decontamination was shown to be successful.

Generally speaking, if the space can be sealed, it can be decontaminated. If you have a service project you'd like to explore, contact us here.

Case Study: Tented Equipment in a Laboratory

ClorDiSys provides biodecontamination services for routine or single-time events, specializing in contamination prevention and response. Last week, our Decontamination Service team was in the Midwest to perform a decon at a research facility.  Our team was brought in to decontaminate a CliniMACS Prodigy® Instrument manufactured by Miltenyi Biotec.  The CliniMACS Prodigy allows for automated cell processing within a closed system and was shipped to the research facility to be used for a contract research project within their laboratory.  The research facility required the decontamination to take place to ensure that the incoming device would be sterile before entering the laboratory.  Being a small device, the CliniMACS Prodigy was moved into an airlock and tented for decontamination.  Tenting the CliniMACS Prodigy took approximately 20 minutes, and the decontamination started shortly thereafter.  The decontamination took a total of 2 hours. After which, the chlorine dioxide gas was removed using a carbon scrubber.  Once complete, the tent was removed from the CliniMACS Prodigy, and it was safe to be brought into the laboratory.

ClorDiSys' chlorine dioxide gas technology allows for a complete decontamination of your facility, room, equipment, or ductwork with minimal downtime. View a sample of some other decontamination service projects here, and Request a Decontamination Service Quote if you have a project you'd like to explore.

AirGlow: In-duct Ultraviolet Light Disinfection System

AirGlow™ is an in-duct ultraviolet light disinfection system that can be installed in any HVAC system. Ultraviolet light (UV) is a specific part of the electromagnetic spectrum of light that offers bactericidal effects. When a micro-organism is exposed to UV-C, the nuclei of the cells are altered due to photolytic processes. This process prevents further replication and causes cell death. As air passes the quartz glass UV-C bulbs of the AirGlow, the travelling air is disinfected, and harmful organisms that may have been present are killed. This provides continuous disinfection without special attention or risk of exposure to people in room.

The AirGlow can be utilized for two distinct purposes. To help reduce and/or eliminate the growth of bacteria, mold and spores as well as prevent the spread of airborne transmitted diseases, the AirGlow would be positioned parallel to the airflow to maximize contact time on the organisms. To improve energy efficiency, the AirGlow would be positioned parallel to the cooling coils. Used in this configuration, biofilm production on the coils is prevented. Biofilms are known to increase static pressure and cause the HVAC system to work harder and less efficient. Clean coils can deliver a 30% increase in cooling capacity which in turn reduces energy consumption and costs.

The AirGlow is constructed of corrosion-resistant stainless steel, and it is offered in a variety of sizes. The following information is required to size an ultraviolet system for duct air treatment:
• Duct or plenum size
• Length of compartment or duct where AirGlow is to be installed
• Air speed typically provided in cfm (cubic feet per minute)
• Approximate air temperature

If you are interested in learning more about the AirGlow™ and how it can benefit your company’s HVAC, call ClorDiSys at (908) 236-4100. If you would like more information about sizes and pricing, request a quote here.

Can Your Facility Benefit from Use of a Portable Decontamination Chamber?

The ClorDiSys Portable Chlorine Dioxide Gas Decontamination Chamber is used in conjunction with a CD Generator to provide a rapid and highly effective method to decontaminate small and medium sized equipment and components. Both the chamber and the gas generator are easily portable allowing for a decontamination station to be set up anywhere in your facility. Items can be treated near the point of contamination reducing the possibility of spreading the potential risk, or components can be sterilized before use, then safely moved under aseptic conditions to a different part of your facility. Decontamination time can be under 90 minutes for a 63 ft3 (1.8 m3) chamber and costs under $7 in consumables per cycle.

The Portable Decontamination Chamber comes equipped with all necessary connections to easily interface with our chlorine dioxide gas generators. All of ClorDiSys' Portable Decontamination Chambers are manufactured with the utmost of care and made of rugged, durable materials to stand up to the demands of continuous use. The Chamber contains removable shelving inside, so both your large and multiple small items can be decontaminated by adding or removing shelving levels as needed.  It can connect to your facility’s exhaust system for direct aeration or utilize an integrated carbon scrubber to remove the gas from the chamber. The Portable Decontamination Chamber pictured is 70"W x 72"H x 30"D (178 cm x 183 cm x 76 cm), and has a decontamination capacity of 75 ft3 (2 m3), however, ClorDiSys works closely with all of its customers to provide a custom solution for any situation.

Visit our product page to learn more or request a portable decontamination chamber quote.

The Dangerous Reality of Drinking a Disinfectant

The FDA recently issued a warning for sodium chlorite products such as “Miracle” or “Master” Mineral Solution. At ClorDiSys, we would like to echo these concerns, as we do not recommend the ingestion of sodium chlorite or chlorine dioxide.  These products are sold online as “treatments” by many independent distributors. Such products go by a variety of names including Miracle or Master Mineral Solution, MMS, Chlorine Dioxide (CD) Protocol, and Water Purification Solution (WPS). Websites selling Miracle Mineral Solution describe the product as a liquid that is 28 percent sodium chlorite in distilled water. When mixed according to package directions with citric acid, that liquid becomes chlorine dioxide.  Some distributors promote on social media dangerous claims that this is an antimicrobial, antiviral, and antibacterial liquid that is a remedy for autism, cancer, flu, and other conditions. However, the U.S. Food and Drug Administration (FDA) is not aware of any research showing that these products are safe or effective for treating any illness. In fact, the agency has received many reports that these products have made consumers sick, and they strongly urge consumers to discontinue their use and not to purchase them.

As a world leader in chlorine dioxide, ClorDiSys Solutions has received phone calls from curious consumers asking if it is safe to ingest these or any of our products. Our response aligns with that of the FDA. Both sodium chlorite and chlorine dioxide are not meant to be consumed by people. Drinking any of these chlorine dioxide products can cause nausea, vomiting, diarrhea, severe dehydration, or even death. Please click here to read more from the FDA’s consumer warning. 

Ultraviolet Light Disinfection UV-C Check Strips

There are many industries where disinfection without the use of chemicals is critical, and ultraviolet light can provide a safe, effective solution. To ensure light exposure during a disinfection cycle, UV-C Check Strips are used. UV-C Check Strips are photochromic intensity indicators that create a simple, reliable, low cost method of monitoring ultraviolet light intensity. The Check Strips have an adhesive backing that allows for easy application to any surface.  When exposed to UV-C, the yellow labels undergo a gradual color change from yellow to green that is directly related to the energy value received.  With increased exposure, the indicator labels will deepen in color. While this color change does not guarantee sterilization, it is a way to provide validation of disinfection in a clear and easy manner.  UV-C Check Strips are important in ensuring that packaging or surfaces have indeed been exposed to germicidal ultraviolet light.

ClorDiSys Disinfection Services

If your facility does not necessarily require a 6-log (99.9999%) sterilization level decontamination, ClorDiSys does offer alternative disinfection options to our chlorine dioxide gas services. However, please note, the difference between spore and bacterial inactivation is the same as the difference between sterilization and disinfection. For a chemical agent to be classified as a sterilant, it must be demonstrated to be effective at inactivating spores, the hardest organisms to kill. Disinfection, on the other hand, does not require the complete inactivation of spores or all microbial life and is normally validated against a few vegetative bacteria species. For this reason, disinfecting agents are less rigorous decontaminating agents and are not as effective as sterilizing agents.

Ultraviolet Light Disinfection Services
ClorDiSys offers ultraviolet light services for contamination response or routine preventive disinfection. Ultraviolet light provides a quick, chemical free disinfection method capable of eliminating viruses, bacteria, and mold from the air and visible surfaces. UV-C is extremely inexpensive, and disinfection cycles are fast, allowing for quick turnover times of the spaces being disinfected. Utilizing products such as our Torch UV Tower, we can get a calculated 99% reduction of bacteria in 1 minute and spores in 5 minutes. Rooms, vehicles, and other enclosed spaces can be disinfected quickly and safely using this residue free process.

Chlorine Dioxide Fogging Disinfection Services
ClorDiSys also provides disinfection fogging services with liquid chlorine dioxide. The liquid chlorine dioxide is sprayed on surfaces at concentrations capable of eliminating viruses, bacteria, fungi and spores. Handheld foggers are used, so a trained technician can reach more surfaces than a stationary fogger, by opening enclosures and changing the angle of application in order to minimize shadow areas which are not being contacted.

In one case, a new facility was disinfected by fogging with a liquid chlorine dioxide to provide a clean start for research taking place within the facility.  A high concentration liquid chlorine dioxide was fogged throughout the facility, similar to a hydrogen peroxide vapor treatment.  A team opened drawers, cabinets, and equipment in order to ensure that all visible surfaces were sprayed and treated with liquid chlorine dioxide. This method offers a level of disinfection comparable to utilizing VPHP.

Reception at the Evan Williams Bourbon Experience

Following the IAFP exhibit hall hours on Monday, July 22nd, ClorDiSys Solutions hosted a reception at Kentucky’s first commercial distiller, Evan Williams. Located on Louisville’s historic Whiskey Row, guests entered through a safe door and took a step back in time to the Age of Prohibition where catered hors d’oeuvres and drinks were served in the venue’s “Speakeasy”.

We also had the opportunity to experience an Open House Tour of the distillery. On this self-guided tour, we passed recreations of the Louisville wharf in the late 18th Century as well as Whiskey Row from the late 1800’s through the present. Evan Williams’ Bourbon Hosts were stationed along the way to educate us and lead in four premium bourbon tastings. Additionally, we saw a state-of-the-art, modern, operating distillery utilizing the same type of pot stills as the early Bourbon-making days.

Thank you to all who were able to join us at this event, and congratulations to those who won our giveaways including an Amazon Fire HD 8 Tablet and an Echo Show. This reception is certainly going to be a tough act to follow in Cleveland for the 2020 IAFP Annual Meeting, but we are up for the challenge.

Decontaminating Dry Processing Environments

This week, the International Association for Food Protection's (IAFP) annual meeting took place in Louisville, KY.  We had the privilege of participating in a session entitled, “Challenges of Sanitation in Dry Processing Environments: What are the Evolving Methods?” Alongside a group of our industry peers, we discussed how dry gasses can be used to complement your sanitation process. During the presentation, we described how “harborage locations” within a production environment only exist when your sanitation method is ineffective at penetrating the cracks and crevices within a facility.  Gases naturally fill up the volume they are contained within evenly, meaning that there are no surfaces which go uncontacted.  

Chlorine dioxide gas and ozone gas are two residue-free, dry gas sanitation methods that are capable of penetrating into crevices further than pathogens can hide.  This is because they have a smaller molecule size than the smallest virus, measuring in between 0.124-0.127 nm. Ozone has difficulty in large environments however, as it breaks down rather quickly with a half-life of about 30 minutes.  This makes it difficult to accumulate the proper dosage at locations further from the ozone generator as treatment times typically range from 4-36 hours.  Chlorine dioxide has a half-life much longer than the treatment time, meaning that there is no natural loss in concentration during the decontamination itself.

Gas decontamination offers a fundamentally better chance of contacting pathogens throughout a facility, which is the biggest challenge to traditional sanitation methods.  Using chlorine dioxide gas as a supplement to your traditional sanitation method in order to provide a periodic “deep clean” will help establish a true “clean break” within your facility.  Whether treating your entire production facility, a single piece of equipment, or the inside of equipment and its piping / PC lines, chlorine dioxide gas is extremely well suited to eliminate pathogens wherever they reside.

Hope for the Best, Prepare for the Worst.

Why are food facilities in need of decontamination? The most obvious is in contamination response. This could be for facilities that are shutdown and in the middle of a recall, or those simply battling some positive swab results in zones two, three or four. For situations like these, ClorDiSys offers pre-planning for an emergency decontamination. First, we would initiate communication between everyone who would potentially be involved. We would sit down with your facilities, quality and EHS people and make sure everyone knew their role if a contamination should occur. Next, we would establish potential scenarios to determine pricing. In most cases, this is better pricing, simply because other companies might see that you are vulnerable in the case of a contamination and see it as an opportunity to take advantage with the price tag. With us, you would know the cost up front and it’s likely to be less because we have planned ahead with you. Also, the preparation would not just involve you and us, but we have access to other professionals in the field who could be helpful. Finally, as long as everything can be taken care of remotely, there is no cost for us to plan this with you and the result would be a well-written procedure that you could keep in your files.

What do we need to create an emergency response plan? The only things that we would need from your company are a floor plan of the facility, the estimated cubic footage, some photos of the area, and information on the exhaust system. The reason for the exhaust system information is that we would need to know how to aerate – either directly into the air or broken down with carbon scrubbers. Preparing this plan with you could also potentially involve a site visit from us to get a better idea of the little details that would go into a successful decontamination.

If you’re ready to get started, email Kevin Lorcheim or call (908) 236-4100. You can also visit us at the IAFP Annual Meeting next week. We are booth #213.

CD Checkstrips: Color Changing Chemical Indicators

CD Checkstrips are designed to provide an easy, quick and cost-effective way to document your chlorine dioxide decontamination process. The 1/2" x 3 3/4" strips offer a visual confirmation that chlorine dioxide gas was present in the area in which the test strip was placed. The check marks on the paper strips will change color from purple to pink when contacted by chlorine dioxide gas. The color-changed strips can be kept as part of your facility log to provide documented evidence that the decontamination process was performed. This color change does not guarantee sporicidal sterilization. For sterilization cycle verification and validation, Biological Indicators (BI’s) should be used. CD Checkstrips are non-hazardous and can be disposed of as regular waste. Click here to request a quote or call our office at (908) 236-4100.