The STERIKING® Gusseted pouches with 3 indicators are for use as packing material for packaging of more voluminous items in sterilization by steam, ethylene oxide gas or formaldehyde. The common steam sterilization conditions are 3 minutes at 134ºC or 15 minutes at 121ºC. The products are for single use only.

Closing of gusseted pouches requires special attention to eliminate wrinkles in the final closure seal.Opening of gusseted pouches calls for special care to minimize any break at points of folded edges.

The STERIKING® See-Through packages are constructed of medical grade paper (70g/m2) is heat sealed together with a multiply PET/PP-plastic laminate (12/40 microns). Recommended sealing temperature for final closing is 165-200°C (329-392°F) depending on pressure and time.

Certifications

• The products are registered by FDA under 510(k) Premarket Submission No. 953776.
• 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 14001: 2004; OHSAS 1800

Sizes

Refer to downloads.

• The paper is a high-weight medical grade with improved barrier and water repellent properties.
• The controlled pore size provides for effective air evacuation and steam penetration.
• The specially treated surface facilitates strong sealing against the film but allows fiber-free peeling off without breaks.
• The paper conforms to the requirements of the European EN 868-3:2009 and it is free from dirt, toxic substances and odor.