Definition
The sterile barrier system refers to the primary packaging that is specifically designed to maintain sterility, protect the product from contamination, and allow for aseptic presentation. For our product syringe and IV set, the sterile barrier system includes PE bags, blister bags, peel pouches(paper pouches), or transparent polybags with medical paper belts, which create a barrier against microorganisms and other potential contaminants.
On the other hand, the protective packaging serves as an additional layer of defense for the sterile barrier system. It includes corrugated outer cartons or other sturdy materials designed to protect physically and prevent damage during transportation, storage, and handling. Referring to our product, syringe and IV set, the double corrugated outer carton is the protective packing that acts as a shield, absorbing shocks and minimizing the risk of any harm that may compromise the sterility or integrity of the product.
By combining the sterile barrier system and the protective packaging, the packaging system ensures that the product remains safe, sterile, and undamaged throughout its journey from production to the end-users.
Types of sterile barrier system and protective packing
Types of sterile barrier system
The main sterile barrier system used in our product, syringe and IV set, is the small PE bag, paper pouch, blister bag, and transparent bag with medical paper belt.
PE bag: The PE bag is a specialized plastic bag crafted from polyethylene, a robust and long-lasting plastic material. These bags are widely chosen as primary packaging for medical devices due to their exceptional strength and durability. One of the key advantages of PE bags is their impermeability to water and microorganisms, ensuring an additional layer of protection for the enclosed products. This feature helps maintain the sterility of medical devices, such as syringes and IV sets, throughout their lifecycle until they are ready for use.
Blister bag: A blister bag consists of a combination of a plastic sheet and a paperboard backing. The plastic sheet is precisely molded into a raised portion, creating individual compartments for packaging medical devices. This design is especially favored in the healthcare industry due to the high level of protection it offers against contamination. Blister bags effectively shield medical devices from external elements, preventing potential damage and minimizing the risk of any unwanted contact with harmful substances. By securely housing syringes and IV sets, blister bags contribute to maintaining the sterility and integrity of these essential medical products.
The peel pouch or paper pouch is a unique type of packaging that consists of a combination of paper and plastic materials. The plastic sheet enables clear visualization of the contents and the chemical indicator. This allows healthcare professionals to easily inspect the contents and verify the sterilization process. The paper side of the pouch facilitates the removal of air, ensuring proper sterilization while also allowing the sterilant to penetrate the pouch and reach the medical devices inside. The peel-open feature provides a convenient and aseptic way to access the enclosed products when needed.
Transparent polybag with medical paper belt: This packaging solution involves a transparent plastic bag paired with a medical paper belt. The transparent plastic bag offers visibility, enabling easy inspection of the enclosed product. It allows healthcare providers to visually assess the contents without compromising sterility. The medical paper belt serves as a microbial barrier, providing additional protection against contaminants. By combining the benefits of transparency and a microbial barrier, this packaging solution ensures that the medical devices remain safe, secure, and ready for use.
Types of protective packing
Our protective packing is the double corrugated outer carton, featuring the construction of two layers of corrugated cardboard (flutes) with a liner board facing between them, offering impressive strength and stability.
Requirement of packing
Requirement for protective packing according to ISTA 2A: 2011
ISTA 2A: 2011 is a standardized test procedure developed by the International Safe Transit Association (ISTA). It is specifically designed as a partial simulation test for individual packaged-products, with a weight limit of 68kg or less when prepared for shipping.
The purpose of ISTA 2A: 2011 is to evaluate the performance of a packaged-product under simulated transportation conditions. By subjecting the package to a series of tests, such as drops, vibrations, and compression, it helps assess how well the packaging can protect the product during the typical rigors of shipping.
This test standard is especially useful for comparing and evaluating different package and product design alternatives. It allows manufacturers and designers to decide on the most suitable packaging solutions for their products. By conducting ISTA 2A: 2011 tests, they can determine which designs provide the best protection and performance, considering factors such as cost, sustainability, and overall functionality.
The test shall be performed on each test in the sequence indicated in the following table:
| Sequence# | Test Category | Test Level | Test Method/ Specification |
| 1 | Atmospheric conditioning | Tropical: 72 hours at 38℃ /85% RH. 6 hour ramp to 60℃. 72 hour dwell at -18℃. | ISTA 2A-2011 |
| 2 | Compression test | Compression test with an imposed load Force apply and release | ASTM D 642-00 and ISTA 2A 2011 |
| 3 | 1st Vertical Vibration Test | Fixed Displacement | ISTA 2A 2011 |
| 4 | Drop Test | Drop cycle with 10 drops | ASTM D 5276-98(09) and ISTA 2A 2011 |
| 5 | 2nd Vertical Vibration Test | Random vibration Spectra Truck/Air Speed-up value 1,15gn in area 1Hz to 200Hz Duration 1 hour | ASTM D 4728-06 Method B and ISTA 2A 2011 |
After conducting the ISTA 2A: 2011 test, the packaging should ideally show no visible signs of damage. This includes no visible tears, punctures, or any other structural or cosmetic damage to the packaging itself. This outcome indicates that the packaging has successfully protected the product during the simulated transportation conditions.
In addition to the packaging, the products themselves should also be free from any visible damage. This means that there should be no observable harm, such as cracks, breakages, or other forms of physical damage, to the individual packaged-products. This demonstrates that the packaging system effectively safeguarded the products throughout the testing process.
The absence of visible damage on both the packaging and the products is an important measure of the packaging system’s performance and its ability to provide adequate protection. It ensures that the packaged-products can reach their destination in the same condition as they were prior to the test, giving manufacturers and consumers confidence in the packaging’s reliability and effectiveness.
Requirement for sterile barrier system according to EN ISO 11607-1:2020 standard for terminally sterilized medical device
The detailed requirements can be referred to our other article The role of sterilized medical device packaging.
