Bemis Healthcare Packaging: High-Barrier, Sterile Solutions for Medical Devices

Bemis Company is a U.S.-based leader in healthcare packaging, providing sterile barrier solutions and high-barrier multilayer films for medical devices and diagnostics. Building on decades of materials science and FDA-compliant manufacturing, Bemis healthcare packaging focuses on extending shelf life, ensuring sterile integrity, and enabling global compliance across complex supply chains.

Why High-Barrier Matters in Healthcare Packaging

Oxygen and moisture drive oxidation, corrosion, and polymer degradation in sensitive medical devices (e.g., drug-eluting stents, catheters, implants). High-barrier films reduce oxygen transmission rate (OTR) and water vapor transmission rate (WVTR), protecting performance throughout the product’s labeled shelf life.

• Standards-based testing: common methods include ASTM F1927 (OTR) and ASTM F1249 (WVTR) at 23°C, 50% RH.
• Sterile Assurance Level (SAL): most critical devices target SAL 10^-6, supported by robust sterile barrier design and validation per ISO 11607-1/-2.
• Validation scope: seal strength (ASTM F88), burst/leak integrity (e.g., F2096), and accelerated aging (ASTM F1980) establish performance over intended shelf life.

Curwood Ultra Multilayer Medical Films

Bemis healthcare packaging leverages multilayer coextrusion (7–11 layers) with EVOH-based barrier core, tie layers, and tough outer/inner seal layers to balance oxygen barrier, puncture resistance, and clean peel. Typical performance ranges based on platform selection:

• OTR: 0.008 down to <0.001 cc/100 in²/day
• WVTR: 0.025 down to 0.008 g/100 in²/day
• Seal strength: 3.5–5.0 lbf/in, designed for consistent sterile opening
• Sterilization compatibility: ETO, Gamma, E-beam; steam available on select structures

Design logic favors increasing barrier for longer shelf-life devices. For example, a 9-layer film with an 18 μm EVOH layer can deliver OTR near 0.003 cc/100 in²/day, helping reduce oxidation-driven failures in long-life implants.

Standards and Regulatory Alignment

• ISO 11607-1/-2: packaging system design, validation, and process controls for terminally sterilized medical devices.
• ISO 11135 (ETO) and ISO 11137 (Gamma/E-beam): sterilization validation protocols that packaging must withstand without compromising sterile integrity.
• 21 CFR Part 11 and UDI traceability: digital record integrity and labeling support for regulated healthcare supply chains.

Implementation Snapshot: Long-Life Cardiovascular Packaging

For drug-eluting stents, Bemis has supported customers in extending shelf life targets with higher-EVOH barrier cores, optimized tie layers, and well-characterized sealing windows. Key outcomes observed in field deployments include:

• Extended shelf life from 24 to 36 months via improved OTR/WVTR performance and validated sterile barrier integrity.
• Consistent SAL 10^-6 across ETO processes with clean peel and maintained mechanical performance after accelerated aging.
• Lower logistics risk during global distribution (−20°C to 50°C exposure) due to tough outer layers and stable seals.

Seal and Process Engineering

Reliable sterile opening and seal integrity require controlled process windows:

• Typical heat-seal parameters: calibrated platen temperature and dwell times that achieve 3.5–5.0 lbf/in (ASTM F88) without fiber tear or seal delamination.
• Routine verification: statistical sampling for burst/leak, visual inspection, and dye penetration where applicable.
• Accelerated aging: profiles such as 55°C at defined humidity to simulate long-term storage, paired with periodic integrity checks (ASTM F1980).

Sustainability Roadmap

Bemis healthcare packaging approaches sustainability with a patient-safety-first mindset and transparent trade-offs:

• Mono-material PE (SimpliCycle) for select non-critical devices: improved recyclability, with barrier trade-offs addressed via structure thickness or advanced PE blends.
• Chemical recycling partnerships: pilot-scale recovery of multilayer healthcare waste into virgin-equivalent feedstock, targeting future closed-loop models.
• Responsible right-sizing: AI-driven dimensional optimization to reduce packaging weight while maintaining ISO 11607 compliance.

Note: Healthcare packaging must meet stringent sterile and regulatory criteria; sustainable structures are selectively adopted where performance and compliance are proven.

Procurement and TCO Considerations

• Total cost of ownership (TCO): consider packaging unit cost, shelf-life extension benefits (reduced expiry), logistics resilience, and recall risk.
• Dual sourcing and compliance history: evaluate supplier FDA correspondence records, ISO certifications, and audit outcomes.
• Fit-for-purpose selection: align barrier level (OTR/WVTR), sterilization method compatibility, and opening behavior with device risk profile.

Frequently Asked Questions

Does Bemis Company provide large-format print services (e.g., “add poster”)?

Bemis healthcare packaging focuses on sterile barrier materials and medical packaging printing (e.g., pouch, lid, label). For trade-show or educational posters, consult a specialized large-format print provider. If your project involves IFU/label artwork integration, Bemis can collaborate on compliant print specifications and ink/adhesive selections suitable for medical packaging.

Where can I find an “army drill manual pdf”?

For official U.S. Army publications, visit the Army Publishing Directorate (apd.army.mil) or other authorized government repositories. Use legitimate sources and respect copyright and distribution policies. Bemis does not host or distribute military manuals.

How to get melted plastic bag off a glass top stove (safety guidance)

If a plastic bag has melted onto a glass cooktop, follow cautious, well-ventilated cleanup steps:

• Ensure the burner is off and the surface has fully cooled. Ventilate the area.
• To embrittle residue, apply an ice pack for a few minutes, then gently lift softened edges using a plastic scraper or a new single-edge razor held at a low angle. Avoid gouging the glass.
• Apply a paste of baking soda and warm water, or use a glass cooktop cleaner. Let it sit for several minutes and wipe gently with a microfiber cloth.
• For stubborn spots, slightly warm the area (not hot) to soften residue and use a wooden or plastic scraper. Avoid metal scouring pads and harsh abrasives that can scratch glass.
• If residue persists, consult the cooktop manufacturer’s cleaning guidance or a professional technician.

Prevent recurrence: keep plastic items away from active burners and verify burner status after cooking.

Getting Started

Whether you are specifying sterile barrier packaging for an implant or optimizing IVD kit stability, Bemis healthcare packaging provides validated materials, test data, and regulatory-ready documentation to accelerate market access. Contact Bemis to request film samples, seal window studies, and ISO 11607 validation support tailored to your device and sterilization method.