Sterilization Process Indicating Ink
Designed to change color* indicating the completion of a sterilization process, Tempilink® is uniquely formulated with chemically-reactive materials sensitive to specific heat levels and/or the presence of certain chemicals used in the sterilization process. The Tempilink product line includes inks formulated specifically for Steam Autoclave, Ethylene Oxide Gas, Hydrogen Peroxide (Plasma), Formaldehyde Gas, Radiation or Dry Heat sterilization procedures. Special formulations such as dual-purpose inks are available which provide confirmation of multi-step processes, such as the use of Steam Autoclave and EO Gas. The color change is permanent and irreversible so the package remains identifiable as having been properly sterilized for the length of its shelf life.
Available in both water and solvent-based formulations, Tempilink is suitable for printing on most conventional packaging materials including Autoclave Kraft Paper, Tyvek®, polyester, polypropylene, polyimide, as well as pressure-sensitive tape and cloth. Most Tempilinks can be stored at temperatures lower than 80°F/27°C for up to six months and can be applied using conventional flexographic printing equipment. Tempilinks are capable of conforming to ISO 11140-1 Standards for Class 1 process indicators.
*Note: Tempilink is intended to change color as proof that the packaging has been exposed to specific sterilization conditions.
It is not intended to replace biological monitors that directly measure spore kill, bacteria kill or other pathogens.
Typical Applications: Tempilink can be printed flexographically and used in virtually any application where a permanent, tamperproof means of confirming the successful completion of the sterilization process is required.
Hospital and Medical Facilities
Printing of peel-pouch packaging for reusable and single-use devices, decontamination bags, and lid stock are common applications. Labels, tags, pressure-sensitive tapes, and dots can also be printed for use during on-site sterilization processes.
Pharmaceuticals & Medical Devices
Printing of packaging, pressure-sensitive labels, tapes and dots allow for a dramatic color change confirming that the pharmaceuticals and medical devices have completed the sterilization process.
Printing of packaging, pressure-sensitive labels, tapes and dots provide an irreversible color change assuring that the products have completed the prescribed sterilization process.
Typical Sterilization Procedures:
DRY: Dry heat at 320°F/160°C for 40 minutes
EO: Ethylene Oxide Gas 600 mg/l concentration at 130°F/54°C for 20 minutes
FORM: Formaldehyde Gas 1,0 mol/l concentration at 158°F/70°C for 15 minutes
IRRAD: E-beam & Gamma radiation 10kGy (1.0 megarad)
Long Cycle – Saturated steam at 250°F/121°C for 10 minutes
Short Cycle – Saturated steam at 273°F/134°C for 2 minutes
VH202: Vaporized Hydrogen Peroxide (Plasma) systems