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Gas Plasma Sterilization as Contract Sterilization by Meise Medizintechnik

Gas Plasma Sterilization as Contract Sterilization by Meise Medizintechnik

Gas Plasma Sterilization by means of hydrogen peroxide is an innovative sterilization procedure. After having been in use in clinical settings for some time it is now making its way into the industrial production of medical products.

Advantages

  • Low operating temperature of 45-55°C
  • Energy-efficient
  • Short circulation times of instruments
  • Sterilization becomes part of the production process
  • Highly suitable for thermosensitive plastics
  • Highly suitable for high quality electronic components
  • No deformation or discoloration of plastics
  • Gentle treatment of sterilized products
  • No risk of corrosion
  • The procedure is run on a dry basis
 

 

more Information About Contract Sterilization:

PROCEDURE

First the products to be sterilized are inserted into the sterilization chamber. Then the chamber is held under vacuum and hydrogen peroxide vapor is injected into this vacuum at a concentration of up to 60%.

The hydrogen peroxide has a sterilizing effect on all accessible surfaces. Then the chamber is put under vacuum again, to remove the lager part of the H2O2.
For cleaning purposes the remaining gas is made to pass over into the plasma state through high frequency voltage. In this plasma various species of H2O2 are produced that are finally recombined as water (H2O) and oxygen (O2).

VALIDATION

To present evidence of the sterilization with the desired degree of certainty, it is shown that at least 106 colony forming units that are particularly resistant to the procedure can be killed during the cycle (worst-case position).

The process is performed twice to achieve the required sterilization (half-cycle procedure). Our tests are supported by an accredited laboratory. Routine inspections and the annual revalidation of the processes are performed by us. This enables us to have a prompt process approval.

As in the case of other sterilization procedures, the bioburden should be known and should be relatively stable. The inspection for a continued high performance, i.e. material inspection should be performed after artificial and actual storage. Biocompatibility tests are run immediately after the dual sterilization as needed.

We will be happy to recommend to you an accredited lab for such tests as required.

POSSIBLE USES

will follow

PACKAGING

To guarantee a good penetration of the packaging material H2O2, cellulose-free packaging should be chosen. Paper and cardboard can not be used for this sterilization procedure because of their interaction with H2O2.

We will be happy to provide you with a quote for your packaging problem.

NON-DESTRUCTIVE

Gas plasma sterilization has several advantages as compared to other sterilization methods. For example, the temperature is adapted to the product. We can perform tailored sterilization in a range of 37° to 60°C. Our standard cycle is run at 50°C. This means that there is practically no thermal load of the sterilized products.

Excellent results are achieved with the sterilization of membranes. It is well known that retention properties are partly lost when they are sterilized with radiation. After a gas plasma sterilization their properties remain unchanged. Similar positive experiences have been made with sensitiveelectronic components.

Gas plasma sterilization has been long used on a routine basis because of the low power loss. The standard procedure is quite sufficient for a lot of products. If it should not be gentle enough for your product the process is adapted to the product configuration.

STERILIZATION TIME

Gas plasma sterilization procedures usually take between one and two hours, including preparation and finishing.

 

LTP-sterilization 

LTP sterilization requires a special material for sterile packaging. Conventional paper-based or cardboard sterile packaging can not be used for hydrogen peroxide because of their absorbent properties. That is why sterilization using the LTP procedure is performed in the primary packaging, using TYVEK® as a sterile barrier system.

LTP sterilization has several advantages as compared to other sterilization methods. For example, the temperature may be adapted to the product. We can perform tailored sterilization in a range between 37°C and 60°C. Our standard cycle is run at 50°C for a sterilization time of 100 minutes. This means that there is practically no thermal load of the sterilized products.

Excellent results are achieved with the sterilization of membranes. It is well known that retention properties are partly lost when they are sterilized with radiation. After gas plasma sterilization their properties remain unchanged. Similar positive experiences have been made with sensitive electronic components. The standard procedure is quite sufficient for a lot of products. If it should not be gentle enough for your product, we can use our extensive know-how to adapt the process configuration to your product.

Validation requires evidence of your product achieving the required sterility assurance level (SAL) under reduced process conditions. For tests to be performed for the evidence of sterilizability of your product we will be happy to refer you to accredited labs. We will perform the required processes as agreed with your lab. As is also the case with other sterilization methods, the biological burden should be known and it should be relatively stable. Special processes may be run for a conformity evaluation of your medical product, where the product is subjected to worst-case treatment conditions.