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.
Designed for healthcare and medical manufacturing environments, this packaging solution is ideal for surgical instruments, diagnostic kits, and implantable medical devices requiring long-term sterility. The high-barrier material protects against contamination, while the transparent design enables quick visual inspection of contents without compromising sterility or opening the package, supporting compliance and operational efficiency.
This packaging is well suited for pharmaceutical products such as oral solid doses, topical creams, ointments, and injectable medications that require protection from moisture and light exposure. The 7-day configuration is ideal for emergency and first-aid kits, while the 31-day option supports bulk hospital inventory management and extended storage requirements.
Commonly used in clinical and research laboratories, this solution is suitable for packaging reagent strips, swabs, and sample collection tools. It maintains sterility and product integrity during cold-chain storage and transport. The durable construction supports consistent handling, regulatory compliance, and reliable performance in demanding laboratory and diagnostic environments.
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) .
