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Brand Name : Hagilin
Model Number : Customerized
Certification : ISO GMP FDA
Place of Origin : China
MOQ : 100PCS
Price : Negotiable
Payment Terms : L/C,T/T
Supply Ability : 1200000pcs/year
Delivery Time : 5-8days
Packaging Details : Double LDPE Bags+ Carton
Alternative Material : medical dialysis paper
Sterilization Compatibility : 121℃ steam (30 min)
Seal Type : Double - side heat seal + pre - cut notches; seal strength ≥30N/15mm
Printing Capability : 8 - color max, 300DPI, ink adhesion ≥4B
Biocompatibility : ≤10 particles ≥5μm during opening
Shelf Life : 2 years (10–25℃, dry, dark storage)
Compliance : FDA ISO GMP
Quick Detail
Material: core alternatives (Tyvek - equivalent performance): Medical - grade dialysis paper (50-75gsm, steam - permeable microbial barrier)+heat - sealable HDPE film; pre - cut easy - tear notches, double - side heat - sealed edges, water - based food - grade ink for full - area custom printing (121℃ steam - stable).
Core Advantages: Non - Tyvek materials with same steam permeability (121℃ max) and ≥0.2μm microbial barrier as Tyvek; fully customizable printing (logo, batch number, expiry date, steam indicator); easy - tear tool - free opening; cost - effective vs Tyvek; GMP - traceable, low - linting, 100% seal integrity testing, biocompatible; NOT for >121℃ steam sterilization.
Compliance: ISO FDA GMP
Application: 121℃ steam sterilization packaging for rubber stoppers, glass vials, cleanroom PPE, surgical instruments, dental tools, pharmaceutical components, and lab glassware.
Custom Options: Size,Print
Description
This printable non - Tyvek steam sterilization bag is tailored for 121℃ steam workflows, offering Tyvek - equivalent microbial barrier and steam permeability at a lower cost, with full custom printing for GMP traceability. It solves the pain points of Tyvek’s higher price and limited supply chains, using proven alternative: medical dialysis paper (excellent steam penetration and microbial block), paired with HDPE clear film for visual inspection and clean peel - seal.
The water - based ink is validated to stay intact post - 121℃ sterilization (adhesion ≥4B), supporting custom content like batch numbers, expiry dates, and integrated steam indicators—critical for traceability in pharma, hospitals, and labs. Pre - cut notches enable tool - free, low - particulate opening in sterile environments, while 100% pressure hold + dye leak testing ensures seal integrity. Made in an ISO Class 7 cleanroom, it meets low - endotoxin (<0.25 EU/mL) and biocompatibility standards, ideal for high - volume 121℃ steam sterilization of rubber stoppers, glass bottles, PPE, and surgical instruments.
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Printable Steam Sterilization Bag with 121℃ Steam Compliance Tyvek Equivalent Microbial Barrier Images |