Micro Needle Roller Steilizaiton Methods

Micro Needle Roller sterilization

Usually, there are two ways that used for the micro needle roller sterilization, 25KGy Co-60 Gamma Ray and the Ethylene Oxide gas ( EO Gas) according to directive EN2852006+A2:2009, or ISO 10993

What is Co-60 Gamma Ray Sterilization

Co-60 is used medically for radiation therapy as implants and as an external source of radiation exposure. It is used industrially in leveling gauges and to x-ray welding seams and other structural elements to detect flaws.

The Benefits and defects of the Co-60 Gamma Ray

There are most benefits for the Co-60 sterilization way, such as no need special demands for the product package,the gamma ray will through the package to be inside, even the plastic,tinfoil. More the sterilization process just takes hours to finish,much quicker and easier.

But there is some defects for the Gamma sterilization, specially for the medical use device that made with plastic materials, during the sterilization process, the gamma ray will generate high temperature, which will cause the plastic to change colors, the light color the plastic materials, the obvious changes, such us with transparent PC and ABS materials, clearly changes to be semitransparent yellow, however, the deep color plastic after gamma ray sterilization without obvious changes, such as dark black.

So, if need the Co-60 sterilization, must consider the plastic color changes caused the high temperature process.

What Are Ethylene Oxide And Sterilization By Ethylene Oxide

Ethylene oxide (EO) is a gas commonly used to sterilize medical devices and products chemically. Ethylene oxide is a potent and highly penetrating alkylating agent. These characteristics make it an extremely effective sterilizing agent. However, at certain levels, ethylene oxide is also capable of causing cancer. Sterilization by ethylene oxide kills microorganisms through exposure to ethylene oxide gas under vacuum and humidity. EO is used either as 100% EO or in combination with carbon dioxide.

What Items Can Be Sterilized By Ethylene Oxide

Standard devices and materials sterilized with ethylene oxide are plastic materials (such as plastic devices), gowning materials, heat-labile equipment, and powders. Materials that can be moist heat sterilized can also be sterilized via ethylene oxide. However, if all materials in your device or product are easily sterilized via moist heat, moist heat is the cheaper and easier sterilization option.

How Is Sterilization By Ethylene Oxide Performed?

The exposure time for most EO sterilizations is relatively long (around 6 hours). The gas aeration period is also lengthy, up to 24 hours or more. After loading items into an ethylene oxide sterilization chamber, a vacuum is applied. Next, the chamber is filled to the desired relative humidity. Then an appropriate concentration of EO gas is added. Items undergoing sterilization rest in the EO gas under vacuum and humidity for the desired exposure time. Finally, the gas is slowly and safely evacuated from the EO sterilization chamber, and the sterilized items are given ample aeration time to support EO off-gassing. For sterilization validations, the D value of biological indicators used for EO sterilization validations may range up to 10-fold over the range of relative humidity values.

The Benefits and defects of the EO Gas sterilization

For the derma roller system line, which made most by kinds of different plastics, the benefits are obvious, that will not cause color change, so no need consider the materials choose during the produce, and meets the different color demands from customers.

According to the EO gas sterilization process, it obviously show that the process will take much longer time than Co-60 gamma ray, and need consider the gas residue, which is harmful and dangerous for human body. So, often after the sterilization process, it often needs 7 days gas release to ensure the residue is safety to human health.

More, in the micro needle roller system line, the EO gas sterilization way needs special package way for the product. Often, we use two kinds of package ways.

First, a cheaper package way,plastic-paper bag, which will also save much labour cost, just need machine to seal the bag. But this package design has few defects.

1. The plastic and paper bag is easy to broken

2. During the sterilization process the risks that wet bag or bulge bag phenomenon will happen

3. The valuation date is shorter considering the goods will not be transferred or stored under standard environment , often the valuation is one year.

Second, the plastic-Tyvek paper package design. This way materials cost is much higher and need more labour cost. But it is no easy to happen broken phenomenon and even under the no standard environment, the valuation will be as long as three years.