Self-Sealing Sterilization Pouch with Internal Steam/EO Indicator

Description

A disposable, single-use self-sealing sterilization pouch designed for safe enclosure of medical devices prior to processing, also known as Medicom SafeSeal Quattro. The pouch supports steam autoclave and ethylene oxide (EO) sterilization and incorporates dual process indicators to confirm exposure to either method. Its construction combines a blue-tinted transparent film with medical-grade paper, enabling clear visibility of contents and reliable sterile barrier performance.

Intended Use

• For packaging medical devices intended for contact with skin or mucosal tissue during sterilization by steam or EO.
• Dual process indicators provide visual confirmation of exposure to the selected sterilization process.

Construction and Design

• Blue-tinted transparent film sealed to medical-grade paper.
• Self-seal closure using polyester-backed adhesive tape; no heat sealer required to close.
• Two printed process indicators (Steam and EO); indicators are process indicators only (not multi-parameter/integrator).
• Seal widths: thermal seal ≈ 9.5 mm (3/8 in); adhesive seal 16 mm (≈ 5/8 in).

Process Indicator Performance

• Steam indicator: pink → cocoa after 30 minutes at 121°C, or 4 minutes at 134°C.
• EO indicator: blue → golden brown after 100–120 minutes at 50°C, 60–85% RH, EO concentration 600 mg/L.

Available Sizes (overall pouch dimensions)

• 57 × 102 mm (2 1/4 × 4 in)
• 70 × 229 mm (2 3/4 × 9 in)
• 89 × 133 mm (3 1/2 × 5 1/4 in)
• 89 × 229 mm (3 1/2 × 9 in)
• 133 × 165 mm (5 1/4 × 6 1/2 in)
• 133 × 254 mm (5 1/4 × 10 in)
• 191 × 330 mm (7 1/2 × 13 in)
• 254 × 355 mm (10 × 14 in)
• 304 × 431 mm (12 × 17 in)
• 108 × 279 mm (4 1/4 × 11 in)

Note: Usable internal area is smaller than the overall dimensions.

Sterility Maintenance and Storage

• Maintains sterility of properly processed contents for up to one year when stored as directed.
• Storage: 15–35°C (59–95°F), <70% RH; protect from light, heat, and humidity.

Regulatory and Compliance

• United States: FDA Class II (Product Code KCT); 510(k) cleared (K070428).
• Canada: Health Canada Class I.

Country of Origin

• USA or Taiwan.