STERIKING® LT-Blueline Heat Sealable Pouches have been designed for use as packaging material for devices for low-temperature (hydrogen peroxide, EO and FO gases) and irradiation sterilization. The packages are printed with a process indicator for vaporized hydrogen peroxide sterilization processes.

The STERIKING® LT-Blueline packages are constructed of uncoated HDPE non-woven, named Tyvek®, (grade 1073 B) which is heat sealed together with a multiply BOPET/PE plastic laminate (12/50 microns). Recommended sealing temperature for final closing is 120-130°C (248-266°F) depending on pressure and time.

Certifications

• The products are registered by FDA under 510(k) Premarket Submission No. K973827.
• The STERIKING® See-Through range of peel packages conform to the international product standards and norms: ISO 11607-1:2006, ISO 11607-2:2006, EN 868-5:2009.
• The products are registered under Class 1 as accessories in compliance with the European Medical Device Directive 93/42/EEC and its amendment 2007/47/EC
• To show compliance with MDD the CE mark is printed on the label of the transport carton.
• Wipak Oy is certified to ISO 9001:2008; ISO 13485:2003, ISO 14001: 2004; OHSAS 18001: 2007 and ISO 22000: 2005.

Sizes

Refer to downloads.

• Tyvek® allows quick passage of sterilising gas and accompanying moisture vapour.
• Tyvek® absorbs significantly less sterilising agent than ordinary medical papers.
• Excellent bacteria barrier properties.
• Enables effective and fast packing.
• Extra strong materials for superior tear strength and puncture resistance.
• Packed in dispenser boxes of 200 pieces.