The term “sterile barrier system” refers to the minimum packaging designed specifically for medical purposes. It plays a crucial role in maintaining the sterility of medical products, protecting them from contamination, and ensuring safe delivery to patients. The packaging must be able to withstand sterilization processes, provide an effective barrier against microorganisms, and allow for aseptic presentation when the contents are needed. By performing these roles effectively, the packaging system ensures that terminally sterilized medical devices such as disposable syringes and IV sets remain safe and effective for use. The following are the detailed roles.
- Minimize risks: The packaging system minimizes safety and health risks to both the user and the patient under the intended conditions of use. It plays a crucial role in preventing any potential harm.
- Aseptic Presentation: The packaging system allows the medical device to be presented in an aseptic manner. This means that it maintains its sterility until the device is unwrapped and used, reducing the risk of contamination.
- Physical Protection: The packaging system provides physical protection to maintain the integrity of the sterile barrier system. It keeps the medical device shielded from any potential damage or external contaminants throughout its journey from production to usage.
- Compatibility with Sterilization: The packaging system is designed to be compatible with the chosen sterilization processes. This ensures that the medical device can be safely and effectively sterilized while inside the packaging, without compromising its functionality or safety.
- Maintaining Sterility: The packaging system is responsible for maintaining the sterility of the medical device. It protects the device from exposure to various conditions and hazards, such as environmental factors, during processing, storage, handling, and distribution until the package is opened or the device’s expiry date.
We recognize the importance of sterile barrier packaging in safeguarding the sterility and overall quality of packaged products (syringes, IV sets, etc). To meet this objective, there are specific requirements that our company adheres to during the inspection of the packaging. The words in blue are what we do in details.
The detailed requirements for sterile barrier system, as outlined by EN ISO 11607-1:2020 standard for terminally sterilized medical devices, are presented below. We have highlighted the actions that we actively undertake to fulfill these requirements:
a) Materials shall be non-leaching and odorless under specified conditions of use to such an extent that neither performance nor safety is impaired and the medical devices with which they are in contact are not adversely affected.
b) Materials shall be free of holes, cracks, tears, creases, or localized thickening and/or thinning sufficient to impair functioning.
We carefully examine the syringe and IV set packaging using both our eyes and specialized tools. Our goal is to make sure it’s in excellent condition, without any signs of damage, cracks, or aging. We have high standards and only approve packaging that meets our quality requirements.
c) Materials shall have a basis weight (mass per unitarea) which is consistent with the specified value.
The weight of the transparent polybag with a medical belt for the IV set is 2.6-3.0g/each.
d) Materials shall exhibit acceptable levels of cleanliness, particulate matter and linting.
Before accepting the syringe and IV set packages, our factory conducts thorough inspections to ensure cleanliness and minimize particulate contamination. Here are the specific standards we follow:
1. We make sure that the primary packaging has initial contamination bacteria levels below 100cfu. This guarantees that the packaging is free from excessive bacterial presence.
2. We assess the particle pollution index of the primary packaging, ensuring it does not exceed 90. This index helps us maintain a low level of particulate contamination, keeping the packaging pristine.
3. The inner packing consists of a tight and dust-proof plastic package. This choice of material and secure packaging helps prevent dust or other contaminants from entering the packaging and compromising product quality.
By adhering to these standards, we prioritize cleanliness and maintain the integrity of our syringe and IV set packaging.
e) Material shall comply with established specific or minimum physical properties such as tensile strength, thickness variation, tear resistance, air permeance and burst strength.
The following tests are conducted to evaluate the tensile strength, tear resistance, burst strength, and peel strength of our primary packaging:
1. Tear resistance test: Based on the method YBB00072005 idt ASTM F-0830, the primary packaging must withstand a force of 20N/15mm (1.33kN/m; ASTM D882) static tension without tearing.
2.Pressure resistance test: This test measures the ability of the primary packaging to withstand pressure. Two primary packages are filled with half water each and placed between two plates. A load of 80N is applied to the packages for 1 minute. The primary packages must not rupture or leak under the applied pressure.
3.Drop performance test: This test measures the ability of the primary packaging to withstand impact. Two primary packages are filled with half water each and dropped from a height of 800 mm onto a concrete floor. The primary packages must not break under the impact.
4.Peel strength test: Based on EN868-7:2009 [Annex E], the primary packaging must withstand a vertical and horizontal peeling force of 1.19N/15mm (0.08kN/m).
f) Materials shall comply with established specific chemical characteristics (such as pH value, chloride, and sulfate contents) to meet the requirements of the medical device, packaging system or sterilization process.
g) Materials shall not contain or release material known to be toxic in sufficient quantity to cause a health hazard either before, during or after sterilization under the conditions of use.
h)Materials shall have microbial barrier properties which are consistent with the specified acceptance criteria unless they meet the criterion of impermeability when evaluated.
Our primary or minimum packing of syringes and IV sets are PE bags, blister bags, peel pouches (paper pouches), and transparent polybags with medical paper belts. These primary packages have the function of microbial barrier.
PE bag: A plastic bag made of polyethylene, a type of plastic known for its strength and durability. PE bags are often used as primary packaging for medical devices because they are impermeable to water and microorganisms.
Blister bag: Packaging made of a plastic sheet and a paperboard backing. The plastic sheet is a raised portion. Blister bags are often used for medical devices because they provide a high level of protection from contamination.
Peel pouch: A peel-open packing made of paper with a plastic sheet. The plastic side of the pouch allows clear visualization of the contents and the chemical indicator. The paper side allows air removal and the sterilant to enter the pouch.
Transparent polybag with medical paper belt: A type of packaging made of a transparent plastic bag with a medical paper belt. The medical paper belt provides a microbial barrier, while the transparent plastic bag allows the product to be easily inspected.
These primary packings all have the function of microbial barrier, which means they help prevent microorganisms from entering the product and causing contamination. This is important for medical devices because it helps ensure they are sterile and safe to use.
In addition to the requirements above, sterile barrier systems shall meet the following requirements.
a)Sterile barrier systems and preformed sterile barrier systems shall meet the requirements of ISO 11607-2.
b)Materials and components, e.g. coatings, ink or chemical indicators, shall not adversely affect the medical device by reaction, contamination and/or transfer before, during or after the defined sterilization process.
The ink on our syringe and IV set primary packages is resistant to sterilization, and will not shift or blur during the sterilization process.
c)If formed by sealing, the specified requirements for seal width and seal strength shall be met.
The seal width is 0.08mm.
Sealing strength of transparent polybag with medical belt: can bear the pressure of -30KPa～35KPa EO sterilization without damage or falling off.
d) Peel-open characteristics shall be continuous and homogeneous, without delamination or tearing of the material that can affect aseptic opening and presentation.
NOTE If seals are not intended to be opened for aseptic presentation, a maximum seal strength limit is usually not necessary.
e) Once formed, the sterile barrier system shall provide seal integrity and/or closure integrity until it is opened at the point of use.
f) Opening a seal or a closure should be irreversible or destructive. If the open seal or closure is reversible, it shall be clearly evident that the seal or closure has been opened.