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Merck Acila Bischof + Klein Furupla Bioclean Texwipe Skin Angel Gloves Dräger Others
Merck Acila Bischof + Klein Furupla Bioclean Texwipe Skin Angel Gloves Dräger Others

CLEAN ROOM PACKAGING B+K CLEANFLEX® PE FLAT BAGS [멸균백]

fileDatasheet_CleanFlex_cf_stpe_01_2023.pdf
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BULK MATERIALS

 > Active pharmaceutical ingredients

 > Excipients

 > Fine chemicals

 > Medical device

 > Plastic components

 > Electronic devices

 > Gloves

 > Garments


CLEAN ROOM PRODUCTION

                >   Extrusion in class 5, DIN EN ISO 14644-1

                >   Printing in class 5, DIN EN ISO 14644-1

                >   Conversion in class 5, DIN EN ISO 14644-1

                >   Particle and biological monitoring in place


STERILIZATION OPTIONS

                >   Ethylene Oxide gazing resistant

                >   Plasma-Sterilization resistant

                >   E-Beam sterilization

                >   Gamma-irradiation

                >   Pre-sterilization can be arranged by B+K.

                >   Certificates of sterilizing process will be provided in original.


CERTIFICATION AND QUALITY ASSURANCE

                >   IR-spectrum of LDPE film

                >   Dimensions and thickness

                >   Seal strength

                >   Particle class 100 as per IEST-STD-CC 1246D


TAILOR-MADE DIVERSIFICATION

                >   Side-gusseted and pre-inserted multiple bags on request

                >   Customised sizes, shapes, prints and packing on request

                >   Thickness from 50-300 um on request

                >   Additives as antistatic, slip-agent, antiblock on request

 

Polyethylene packaging is the easy solution against contamination. Sealed it provides perfect protection for bulk products and ensures the cleanliness level of the clean room as well. The clean room chain remains closed for save and clean operations along all your processes.


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MATERIALS USED
                 >   100% LDPE film-medical grade

STANDARD PRINTING
                 >   Transparent without ink
                 >   'CLEANFLEX'
                 >   B+K lot number for full traceability

STANDARD PACKING
                 >   Bags in 2 protection bags                 >   STPE15: 100 bags / bundle
                 >   Bundle labelled for tracebility             >   STPE20: 100 bags / bundle
                      incl. gamma-irradiation indicator        >   STPE30: 100 bags / bundle
                 >   Bundles in small cardboard boxes       >   STPE50: 50 bags / bundle
                 >   Units per pallet mentioned above       >   STPE60: 50 bags / bundle
                 >   10 customer samples per pallet

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