The STERIKING® LT-Blueline Self-sealable Pouches are designed for use as packaging material for medical devices in low-temperature (hydrogen peroxide, EO and FO gases) sterilization in health care establishments. 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).

The HDPE non-woven (Tyvek®) complies with the requirements of the European standard EN 868-9:2009 for uncoated HDPE non-wovens. Tyvek® consists of pure HDPE fibers. It is free from dirt, toxic substances and odor.

It does not release any fluff or fibers during normal use. All components of Tyvek® 1073B are listed with the DA and have an assigned Drug Master File

Certifications

• The products are registered by FDA under 510(k) Premarket Submission No. K973827.
• The STERIKING® See-Through range 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.