Cleanflex® Tyvek®/HDPE Bags
® CleanFlex ST TYVEK® / HDPE STERILIZABLE BAGS
® This packaging is ready-to-use for the customer due to the full Tyvek front and the rear from HDPE film, which enables sterilization without contamination risk. A standard printing including an indicator dot shows successful treatment during sterilization.
BULK MATERIALS > Plastic and rubber stoppers > Closures > Caps and seals > Injection-systems > Dosing pumps > Atomizers > Syringes > Processing tools
® CleanFlex ST – STANDARD PROGRAM
code external sizes (W x L) internal sizes qty / full pal. qty / box
STTH20 200 x 350 mm – 8” x 14” 180 x 300 mm 10.010 pcs 500 pcs
STTH32 320 x 450 mm – 13” x 18” 300 x 400 mm 4.810 pcs 200 pcs
STTH40 400 x 550 mm – 16” x 22” 380 x 500 mm 4.010 pcs 200 pcs
STTH50 500 x 650 mm – 20” x 26” 480 x 600 mm 4.010 pcs 200 pcs
STTH100 1000 x 1230 mm – 40” x 48” 980 x 1200 mm 810 pcs 100 pcs
STANDARD PACKING STANDARD PRINTING
® > 100 bags in 2 protection bags > ‘CleanFlex ’ and full description > Inner bag labelled for traceability > B+K code number > Bundles in small cardboard boxes > B+K lot number for full traceability > Units per pallet mentioned above > Indicator dot for steam sterilization > 10 customer samples per pallet (pink/brown)
For STTH100: For STTH100: > > 20 bags in 2 protection bags Just indicator dot and > B+K lot number printing Inner bag labelled for traceability > Bundles in small cardboard boxes > 10 customer samples per pallet
Marketing Datasheet STTH – rev 10 – 2016-01 ® CleanFlex is a registered trademark of Bischof + Klein SE & Co. KG ® Tyvek is a registered trade mark of DuPont Co.
® CleanFlex ST TYVEK® / HDPE STERILIZABLE BAGS
MATERIALS USED STERILIZATION OPTIONS
® > Uncoated Tyvek – 75 g/m² > Steam sterilization up to 125 °C / 15 – 20 min. > HDPE film composition – 80 µm > Ethylene Oxide gazing > Plasma-Sterilization > Gamma-irradiation CLEAN ROOM PRODUCTION
> Qualification as per DIN ISO 14644-1, at rest FULL TRACEABILITY > Extrusion of HDPE film in ISO class 5 > Cleaning of Tyvek® in ISO class 5 > Optional lot number printing on all bags. ® > Printing on Tyvek in ISO class 5 > Full labelling of bundles and pallets. > Conversion of bag in ISO class 5 > Documentation of resin batches. > Bundling and packing in ISO class 5 > IR spectrum as a proof of material origin. > Particle and biological monitoring in place > Certificate of Analysis with every production.
LONG TERM STABILITY ANALYSIS CERTIFICATION AND QUALITY ASSURANCE
> No change of physical properties (5 years). > IR-spectrum of HDPE film composition > No change on indicator functionality (5 years). > Dimensions and thickness > Seal strength > Particle class 200 as per IEST-STD-CC 1246D REGULATORY COMPLIANCES *
> 2011/10/EC (most recent edition) - Food approved TAILOR-MADE DIVERSIFICATION > Compliance to FDA 21 CFR > 94/62/EC and CONEG– heavy metal declaration > Customised printing ® > EMA 410/01 regulation – BSE/TSE statement > Full Tyvek packaging material is also possible > USP <661>, <88> and class VI > Other indicator labels and prints for other sterilization options * After ordering, official certificates / statements will be issued based on the individual material.
CONSISTANCY OF SUPPLY POLICY
> Strict Change Control procedures for changes in process. > Call-off orders and warehousing as options for contracted business.
Marketing Datasheet STTH – rev 10 – 2016-01 ® CleanFlex is a registered trademark of Bischof + Klein SE & Co. KG ® Tyvek is a registered trade mark of DuPont Co.