Cleanroom Documentation Systems Details

Cleanroom Documentation Systems Details

Description

CleanPrint 10®, Core2Write®, and Core2Print®

CleanPrint 10 is a synthetic writing substrate that has been manufactured using patented technologies to assure strength, very low particulate generation, non-shedding characteristics, abrasion resistance, water resistance, chemical resistance, inability for ink to smear, and the ability for lamination. CleanPrint 10 is designed for ultraclean manufacturing environments and is void of any cellulose in its construction.

Each page of CleanPrint 10 is printed with a 10% screen of light blue so that end users and identify that ClenaPrint 10 is in use as opposed to regular paper. CleanPrint 10 is packaged in reams of 500, available quadruple bagged in VAI’s ABCD Cleanroom Introduction System®, available sterile or non-sterile, and available in 8.5”x11” or A4 sizes.

CleanPrint 10 is the base material used in the custom design of VAI’s Core2Write products. Core2Write is a patented technology that revolutionizes the method of cleanroom documentation by providing custom printed logbooks, one part tags, two part identical tear off tags, labels, and forms. The Core2Write line starts with a custom customer evaluation of what documentation materials are required. Once determined, such documents and artwork are digitally designed into the product required, printed, and RIFD, QR coding, and/or bar coding integrated.

All Core2Write products are fully customized to the facility’s needs. Depending on these needs the following items can be customized: color, company name, logo, SOP Name & Number, Document Revision Number, RFID, bar coding, QR Coding, lamination, specific entry requirements, packaging, bagging, labeling, and sterility. Core2Write products, via its RFID inlay capabilities, are compatible with VAI’s Core2Scan end-to-end tracking system. In addition, the Core2Write line offers gamma irradiated sterile sharpies and pens for use alongside the documentation materials.

CleanPrint 10 is the printing medium used with the Core2Print cleanroom printing system. Core2Print is a patent pending technology that revolutionizes the method for printing required sterile documentation within aseptic manufacturing environments. The Core2Print is constructed of 316L stainless steel for durability and lexan windows for a clear view of the printer in operation. HEPA filtration in the cabinet is a mandatory feature. Therefore, positive pressure within the cabinet is equally filtered to the controlled environment and the cleanroom stays clean throughout documentation efforts.

The entire Core2Print unit is chemical resistant and can be completely disinfected with VAI’s sterile sanitizers, disinfectants, and sporicides. The Core2Print is sheet fed, high speed, digital quality, and has a high quality resolution that prints on CleanPrint 10 with chemical resistant and permanent ink. The Core2Print unit has been made for Grades A, B, C, & D and has wireless capabilities so documentation required in the controlled areas can be signaled to print in the core from the exterior.

Patents: www.sterile.com/patents

Additional Information

  • Features and Benefits of CleanPrint 10
    • Abrasion, tear resistant, and smear resistant
    • Lightweight and flexible but exceptionally durable
    • Inks adhere and dry immediately
    • Chemical and water resistant
    • Remains pliable in extreme temperatures, -70 °C to 180 °C
    • Cellulose free and extremely low in particulates and shedding features
    • Excellent ability to write
    • Substrate recycles as a plastic
    • Available quadruple bagged in VAI’s ABCD Cleanroom Introduction System®
    • Reams are individually labeled with lot number and expiration
    • Available sterile gamma irradiated 10-6 SAL
    • Sterile versions are lot sterility tested according to current USP compendium
    • Delivered with lot specific documentation
    • Completely traceable from start to finish
  • Product Uses of CleanPrint 10
    • Opposed to regular paper
    • Batch record retention
    • Recording data and note taking
    • Equipment manuals
    • Work instructions or procedures
    • Printing with the Core2Print
  • Features and Benefits of Core2Write
    • Fully customizable to your operation with procedure & logo printed including SOP#, REV Date, procedure name, page number, and unique sequential number
    • Available in thousands of colors and color schemes in order to distinguish between items
    • Can incorporate RFID, bar coding, and QR coding for traceability purposes
    • Available fully or partially laminated with easy write areas
    • Labels have easy peel off, a non-shedding back, and have excellent adhesion
    • Tear-apart tags have easy tear perforations that will not shed and have optional hole punching in place of choice
    • Logbooks have non-shedding plastic spiral binding and rounded corners to eliminate bending
    • Logbooks can incorporate side stair stepping edge separation so ripped out pages can be ascertained
    • Available quadruple bagged in VAI’s ABCD Cleanroom Introduction System®
    • Available sterile gamma irradiated 10-6 SAL
    • Sterile versions are lot sterility tested according to current USP compendium
    • Delivered with lot specific documentation
    • Completely traceable from start to finish
  • Product Uses of Core2Write
    • Document GMP operations in grade A/D environments
    • Label or tag GMP containers
    • Label or tag transfer cans/tanks/bottles
    • Traceability via bar coding, QR coding, or RFID via VAI’s compatible Core2Scan System
  • Features and Benefits of Core2Print
    • HEPA filtered with a sealed cabinet so contamination exiting to the controlled environment is reduced
    • Can be fully disinfected with VAI’s sterile chemicals
    • Sheet fed, high speed and digital quality printer that can print 12 inches per second, ~60 pages per minute
    • High quality resolution, up to 1600 x 1600 dpi
    • Ink dries in 0.19 seconds
    • Rich colors at full-bleed, excels in printing readable small fonts and sharp barcodes
    • Ink is a water based dye that is chemical resistant, permanent ink
    • Prints wirelessly
    • Prints onto CleanPrint 10
  • Quality and Manufacturing of Core2Print
    • Constructed of 316L Stainless Steel that is chemical resistant
    • Printer is completely housed within the Core2Print unit
    • Side windows constructed of lexan for a clear view of the printer in use
    • Standard buttons and lights are programmed into the unit to indicate print status and warnings
    • Intake and exit trays with adjustable guides
    • White swivel caster wheels and push handle for easy transportation and maneuvering
    • Core2Print compatible ink is double bagged sterile
    • Delivered as a complete unit
  • Technical Documents