Sterilization Indicators
A REVOLUTIONARY CHEMICAL STERILIZATION INDICATOR TECHNOLOGY
EXECUTIVE SUMMARY: JP Laboratories, Inc,Middlesex, NJ has developed a revolutionary class of chemical sterilization indicators (CSI) which change from silvery white/opaque to clear and display the same message, e.g., “PROCESSED”, a barcode and/or green color upon sterilization, irrespective of the sterilant or the class. This patented technology is based on etching/destruction of an opaque metal/aluminum layer by sterilant selective etchantsto make the message printed underneath visible.UniSterIndi has a rare combination of unique and the most desired properties, such as (i) self-reading, (ii) barcode/machine readability for inventory and record keeping, (iii) the same message for all sterilants and classes (universalizing the technology – no need for training the users), (iv) abrupt change from opaque to clear after ~95% of the reaction time (the most desired, the essential and rarely found property for sterilization indicators) and (v) the least expensive (still premium price can be charged). According to one report, the market for chemical sterilization indicators inks was $30M in 2013 and is expected to grow to ~$50M by 2020. The market for the printed indicators may be a few hundred million dollars per year. UniSterIndi is capable of making the current a big jungle of color changing indicators obsolete and capturing most of the CSI market.
Design
UniSterIndi are made, for example, by printing a message, such as a barcode, “PROCESSED” and/or green color on the plastic side and applying a coating composed of a binder and a precursor for an etchant on the metal layer of a metallized plastic film. The message is not visible when viewed from the metal side. The etchants or their precursors do not react with the thin metal/aluminum layer unless sterilization conditions are met. Under proper sterilization conditions, the sterilant (or etchant produced by the reaction between the precursor and sterilant) reacts/etches the metal layer and destroys it, thereby making the pre-printed message visible. The reaction is completely irreversible. Paper thin moving boundary CSI are created by applying a wedge shaped barrier layer between the metal and the activator layers.
RARE COMBINATION OF UNIQUE AND THE MOST DESIRED PROPERTIES
One of the most unique properties of UniSterIndi is its induction period of the reaction. Many metals like aluminum have a naturally formed hard to destroy protective oxide layer. It takes more than ~80% of the time to destroy the oxide layer, which can be extended to ~95% by applying a polymeric barrier layer. UniSterIndi has a rare combination of the most desired properties, such as(i) self-reading (e.g., “PROCESSED”), (ii) long induction period (an abrupt change from opaque to clear, i.e., go/no-go type after ~95% of the reaction), (iii) human and machine readable (green color can be easily noticed and a machine readable barcode can be used for record keeping), and (iv) simple to manufacture and the least expensive system for quality assurance. They provide the same change/message (name of sterilization process on silvery white opaque layer and display “PROCESSED”, barcode and/or green color) upon sterilization for all classes (I-VI) and all sterilants/processes. UniSterIndi eliminates the confusion of current CSI and will universalize and modernize the CSI technology.
STERILANT SELECTIVE ETCHANTS/PRECURSORS
ypically, each activator of the ink/coating of UniSterIndi is selective to one sterilant, e.g., sodium chloride for steam only and similar non-toxic etchants or their precursors for other sterilants and processes, such as wash, dry heat, ETO, hydrogen peroxide/plasma and radiation. UniSterIndi which responds to two or more sterilants, e.g., steam and ETO are made by mixing the activators/precursors of each sterilant/process in proper proportions. No toxic materials are used to make UniSterIndi and they are unaffected by ambient conditions. All UniSterIndi are made from a small number of materials, such as a metallized plastic film or a metal ink and sterilant selective etchants or theirprecursors. Commercially available equipment can be used for manufacturing UniSterIndi.
INKS
Solvent and water based UniSterIndis inks are easy to manufacture. The inks are made simply by mixing an etchant or its precursor in a binder containing fine (micron sized) particles of aluminum, commonly known as metal inks. The ink is coated on a pre-printed message, such as “PROCESSED”, a barcode and/or green color. Under proper sterilization conditions, the etchant destroys the opaque metal particles which makes the message printed underneath visible only when sterilization conditions are met.
UNIVERSALIZATION
By selecting proper etchants and their precursors, JP Laboratories has been successful in developing CSI for most of the sterilants and processes, such as steam, dry heat, ETO, hydrogen peroxide/plasma, nitrogen dioxide, chlorine dioxide, peracetic acid and radiation. Thus the same message,“PROCESSED”, green color, and/or barcode appears irrespective of the sterilant, process or the class,thereby universalizing the CSI technology.
INTELLECTUAL PROPERTY
Patents on this technology are issued in US (USP # 8,343,437), China, Russia, Japan,Canada, Australia, Korea, Europe and South Africa. They are pending in Brazil, India, and Israel (allowed).
DO-IT-YOURSELF DEVICE FOR MONITORING RADON
Radon is a radioactive gas which is found in the basements of houses. Radon can cause cancer. Commercially available devices are expensive and need to be returned for analysis. JP Labs has developed a do-it-yourself device for monitoring radon gas which leaves a permanent record with the user. The device has a color producing layer. It is based on the etching of latent tracks produced by the particles emitted by radon which are made visible to naked eye by etching. The concentration of the radon gas is determined from the number of track spots using a calibration chart/table.
CONTACT:
JP Laboratories, Inc. develops new products/processes and licenses them to other companies for manufacturing and marketing on a royalty basis. For additional information, contact Dr. Gordhan Patel,gnpatel@jplabs.com, 732 469 6670.
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