Plastic Type | PET |
Industrial Use | Medicine |
Custom Order | Accept |
Color | Transparent |
Certificate | ISO9001:2015 |
The 7/31-Day Cold-Seal Blister Pack for Medical is a sterile packaging solution engineered to maintain the integrity of temperature-sensitive medical devices and pharmaceuticals. Compliant with ISO 11607-1:2020 and FDA regulations, this packaging system provides a reliable sterile barrier for up to 31 days post-sterilization, making it ideal for short-term and medium-term storage needs. Unlike traditional heat-sealed packaging, its innovative cold-seal technology uses pressure-sensitive adhesives, eliminating heat exposure that could damage delicate components. This design ensures high product visibility through a transparent blister while offering robust protection against microbial contamination and physical damage during transportation and storage.
Material & Compliance
Constructed with medical-grade PET and a food-safe pressure-sensitive adhesive, the blister pack meets ISO 11607-2:2020 requirements for sterile barrier systems. It undergoes rigorous microbial challenge testing using Bacillus subtilis spores (ATCC 9372) at concentrations ≥1×10⁶ CFU per package, ensuring no bacterial growth after 7 days of incubation .
Cold-Seal Technology
The heat-free sealing process protects thermally sensitive products such as vaccines and biological agents. This method reduces energy consumption by 40% compared to heat sealing and enables faster production turnaround with consistent seal integrity .
Durability & Traceability
The blister pack withstands ISTA 3A transportation testing, including vibration, drop, and stack tests, ensuring durability during logistics. It supports UDI (Unique Device Identification) labeling, facilitating compliance with EU MDR and FDA traceability mandates.
Sterile Medical Devices
Perfect for packaging surgical instruments, diagnostic kits, and implantable devices that require long-term sterility. The transparent design allows visual inspection without opening the package.
Pharmaceutical Applications
Ideal for storing oral solids, topical creams, and injectables that need protection from moisture and light. The 7-day option suits emergency kits, while the 31-day variant is preferred for bulk hospital inventory.
Laboratory Use
Used in clinical labs for packaging reagent strips and sample collection tools, maintaining sterility during cold-chain transport.
Is the packaging compatible with ethylene oxide (EO) sterilization?
Yes, the materials are EO-compatible and designed to release residual gases within 48 hours, meeting ISO 11607 standards for sterilization compatibility .
Can the blister pack be customized with printed instructions?
Absolutely. The cardstock backing supports full-color printing, including dosage instructions, expiration dates, and batch numbers, using FDA-approved inks.
What is the shelf life of the unopened blister pack?
When stored at 25°C (77°F) and 60% relative humidity, the packaging maintains sterility for up to 2 years, verified through ASTM F1980 accelerated aging tests (55°C for 28 days) .
