Performance Packaging
Revolutionizing Aseptic Packaging

“All you need is a little faith, trust, and pixie dust.”— Peter Pan

One might wonder what the classic Disney character Peter Pan and a leading supplier of flexible packaging products, Performance Packaging, have in common. The answer is Pixie Dust. Analogous to the way how all fairies used Pixie Dust to fly, the 23-year-old Performance Packaging is revolutionizing flexible and rigid packaging with its patented process of “liquid-to-gas” sterilization, dubbed as “Pixie Dust.” As metaphorical as it sounds, Pixie Dust can be leveraged to sterilize stand-up pouches, bag-in-box, or any sealed package in a ‘magical’ way. Featuring an alternative aseptic process to sterilize flexible packaging and its contents, Pixie Dust is an advanced, non-thermal sterilization technology that has many medical and industrial applications. The fact that it can be used as a liquid or a gas and is effective at room temperature in five seconds or less, hints at its enormous potential.

Eliminating the need for conventional methods of sterilization like hot-filling, retort processing, pulsed light or electron-beam irradiation, peroxide or peracetic baths and sprays, the firm’s new sterilizing technology features generally recognized as safe (GRAS) materials and allows sterilization in less than 48 hours at room temperature during storage or shipping. “The unique facet of Pixie Dust is that the Pixie Dust at the time of application is already under the FDA threshold of regulation, making it completely safe from the beginning,” says Robert Reinders, founder and president, Performance Packaging. “Pixie Dust also has the potential to provide greater efficiency for processing machinery. It allows faster processing with reduced utilization of chemical products and energy.”

Introducing more sustainable packaging, while keeping costs and functionality in line, Performance Packaging traverses beyond the tried-and-true methods of sterilization in the commercial marketplace. While the push toward aseptic packaging is evident in the market, Pixie Dust is meeting the need for shelf-stable products in aseptic packaging that comes with a quicker timeframe and a smaller machinery footprint. “The most important thing that we do is on-time product delivery. We customize applications to a client’s needs, based on our wide range of capabilities. Be it a medical device, a pharmaceutical tech packaging or even a bag for fruit packaging, the same technology is applied in the process,” informs Reinders. This technology has many potential applications for medical, dental, pharmaceutical, food, packaging, equipment, and article sterilization.

Pixie Dust was born with the singular aim to perfect the science of packaging to meet the demands of the ecosystem. “Attention to detail is critical in our industry. Even one aspect if missed out can lead to thousands or even millions of dollars of recalled products.

With our Class 100K clean rooms, training companies and facilities, Performance Packaging is not only developing this technology for sterilization but is also providing the packaging for pharmaceutical companies,” adds Reinders.

With over 30 years of in-depth experience in the production, operations, and sales/marketing of flexible packaging products, Reinders is leading Performance Packaging to venture into the realm of innovation in the flexible packaging industry, where many tread skeptically. Reinders along with Joseph Dunn—Ph.D., with 30 years of experience in industrial biochemistry and microbiology relating to packaging research—VP of Research and Development and Regulatory Affairs, Performance Packaging, has embarked on a journey to revolutionize the packaging world. “In Vaporized Hydrogen Peroxide (VHP) sterilization, VHP being hot condenses on the surface of whatever is in the room. However, with our technology, there is no condensation involved; the gas works extremely rapidly,” explains Dunn.

Tapping the Pixie Dust Potential

During the testing of the company’s new sterilization method for surfaces, packages, and articles, Bacillus atrophaeus spores—a spore-forming bacterium utilized in the production of biological indicators for sterilization—spores were added in high numbers and concentrations to the package contents along with a specific quantity of the Pixie Dust agent to verify its disinfection and sterilization capabilities. In essence, the high relative resistant nature of Bacillus atrophaeus spores to chemical disinfectants makes them the best fit for such testing and verifications. Besides, it is also recommended by the U.S. and other international guidelines and Pharmacopeias as the bioindicator reference test organism for chemical disinfectants and sterilization agents.

The unique facet of Pixie Dust is that the Pixie Dust at the time of application is already under the FDA residuals regulation, making it completely safe from the beginning

To manifest the disinfection and sterilization effects as a liquid, tests were performed by injecting 91,000,000 (7.96 logarithms) colony forming units (CFU) of Bacillus atrophaeus spores into a relatively low concentration of Pixie Dust equilibrated to 10°C or 20°C (nominal room temperature). “The fastest time to inject the spores, withdraw a sample, and quench the reaction was five seconds, which also served as the minimum experimental exposure time,” explains Reinders. “No surviving spores were recoverable even after this brief minimal five-second exposure. Therefore, we state an effective treatment time as five seconds or less.”

Disinfection and sterilization effects as an evolved gas (Pixie Gas) were demonstrated with Pixie Gas sterilization of articles in sealed containers, wherein spore inoculated stainless steel (ss) coupons were used as spore carriers. These ss coupons were inoculated by drying a 10μL droplet containing more than one million Bacillus atrophaeus spores onto each ss coupon. Besides, the evolution of sterilizing Pixie Gas in a bag in box containers was tested using a 4L high barrier, hot-fill BIB bags. These tests examined the inactivation/sterilization effects of treatment on droplets of Bacillus atrophaeus spores for various times of incubation at room temperature (20°C).

The results obtained were impressive. The lack of spore survival after about one day of incubation was a testament to the efficiency of the Pixie Dust gas that eventually evolved and diffused through the bag. Subsequent testing showed that this time can be reduced by increasing the concentration of Pixie Dust which accelerates the diffusion phase (concentration drives diffusion). Sticking with a 24 hour or longer exposure time and the low concentration of Pixie Dust used, it was found that only 40μL of Pixie Dust was sufficient to sterilize a 4L bag, containing 51,000,000 spore CFUs (7.7 logs). “We have designs and methods in place where you can take the product in and out of the treatment zone and isolate the sterilization agent from the environment, without leakage. We look forward to performing sterilization in areas like pre sterilization of an aseptic filling machine, a closet or room with the gas method,” adds Reinders.

Next, Performance Packaging’s unique Pixie Gas was tested for sterilizing stand-up pouches. The initial spore inoculation level in the ten-ounce gusseted, flexible, stand-up pouches was more than 6.6 log CFU. After incubation under ambient conditions, the ss spore carrier within the container was sterile.

It was also found that Pixie Gas can be generated on a preformed basis and then moved to exert its sterilizing effects to where they are needed. “We can design small chamber-based equipment to sterilize medical and dental equipment rapidly in a matter of few minutes,” says Dunn. An experimental arrangement was carried out to test the ability of Pixie Gas to sterilize articles inside a Tyvek pouch within a chamber. As an added complexity, the spore inoculum site on the ss coupon was placed opposite the Tyvek pouch window and against the plastic side of the pouch. When exposed to Pixie Gas for 10 minutes, no viable spores could be recovered from the ss coupon. For evacuation and opening of the chamber, the Pixie Gas can be passed rapidly through a scrubber and safely vented to the room.

Spore inoculated ss coupon in a Tyvek pouch with the inoculation site, face down and away from the Tyvek window such that for effective treatment, the Pixie Dust gas must go into the dental tray, through the Tyvek window and around the ss coupon to reach the spore inoculum. This Tyvek pouch combination was then treated while inside of a standard medical/dental tray in a five-gallon chamber. Sterility was achieved after 10 minutes of treatment. “The existing methods of sterilization of dental equipment can curb their lifespan, owing to exposure to heat. With Pixie Dust, those tools last much longer; on the other hand, faster sterilization process saves time for the doctors,” explains Reinders.

Beyond the Tried-and-True Conventional Methods of Sterilization

While these experimentations have yielded remarkable outcomes, the company’s technology is just the tip of the iceberg. With Reinders and Dunn at the helm, Performance Packaging is extending the limits of what is possible in sterilization. To broaden the scope of their technology in the realm of packaging, device sterilization, as well as foodstuff shelf life extension, the company is currently reaching out to worldwide partners in the pharmaceutical and food industries. “The potential for development of a rapid turnaround, non-thermal equipment sterilizer has been demonstrated and is under further development,” says Reinders. “We are currently looking at the utility of the method to sterilize gauze and wound dressings and to penetrate tubing and lumens. The day is not far when this sterilization technology will be part of everyday workflow.”