Medical apparatus and method for sterilizing medical apparatus

Abstract

According to embodiments, there is provided a medical apparatus including one or more sterile pre-filled syringe, one or more first protective container including the one or more sterile pre-filled syringe, wherein the first protective container may be completely or partially filled with an inert or non-inert gas, wherein the one or more first protective container is impermeable to moisture and / or sterilizing agents, and a second protective container including one or more medical components and the one or more first protective container, wherein the second protective container may be, but is not necessarily, completely or partially filled with an inert or non-inert gas. In some aspects, a package mostly impermeable to bacteria including the first and second protective containers is also completely or partially filled with an inert or non-inert gas.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]The present application relies on the disclosures of and claims priority to and the benefit of the filing dates of U.S. Provisional Application No. 62 / 454,651, filed Feb. 3, 2017, and U.S. patent application Ser. No. 15 / 888,020, filed Feb. 3, 2018. The disclosures of those applications are hereby incorporated by reference herein in their entireties.BACKGROUND OF THE INVENTIONField of the Invention[0002]The present invention discloses a method for sterilising medical kits or apparatus, including pre-filled syringes, and also the contents of novel, sterilized medical kits comprising, in part, pre-filled syringes.Description of Related Art[0003]In medical interventions or procedures, one or more medical devices, pharmaceutical products and / or other apparatus are typically used. Depending on the medical procedure being performed, different products and devices will be employed. In some situations, it may be difficult to predict specifically w...

AI Technical Summary

Benefits of technology

The present invention provides a process that can sterilize a pre-filled syringe while maintaining its quality and contents. This ensures that sensitive medical materials are delivered in highly sterile conditions, which is becoming a requirement for modern medicine. Overall, the process helps to prevent bacterial contamination and ensures the delivery of medical materials in the purest form.

Problems solved by technology

In some situations, it may be difficult to predict specifically what types of medical device(s) and / or medicaments will be required at the outset of a medical procedure.

While those skilled in the art will be familiar with methods for sterilising pre-filled syringes, the situation becomes more challenging when the pre-filled syringe is provided as part of a medical kit.

While the sterilisation of certain components conventionally employed in medical kits may not be problematic owing to their ability to withstand harsh sterilisation conditions, the same may not be true for pre-filled syringes either as a result of the material from which the syringe body or various parts of the syringe are formed, or because of the sensitivity of the product contained within the syringe.

In many cases, products formed of woven or textile materials (e.g., gauzes, bandages) cannot be sterilised using such techniques without those products being damaged.

For example, cellulose based materials are not compatible with NO2 sterilization and require protecting separately.

However, there are also products and devices for which many of these sterilisation approaches will be inappropriate.

While this sterilisation approach is capable of being used in connection with products and devices that are heat, moisture and irradiation-sensitive, problems may arise when pre-filled syringes are sterilised with ethylene oxide.

The principal concern regarding the use of ethylene oxide sterilisation with pre-filled syringes relates to the ingress of the ethylene oxide into the pre-filled syringe which can contaminate the product within the syringe and lead to unacceptable levels of residual contaminants in that product, especially in the case of products intended for neo-natal and pediatric populations.

The concerns regarding the ingress of ethylene oxide into the syringe are especially acute for pre-filled syringes constructed from plastic materials, such as polypropylene, owing to possible leaching of ethylene oxide through the syringe body and contamination of the contents.

Once inside, the gas is difficult to dissipate quickly.

The interaction of ethylene oxide gas and iodine-containing solutions is that it can result in the formation of additional toxic residues.

Accordingly, for those engaged in providing medical kits and for those who have invested in the costly devices needed to employ ethylene oxide sterilisation, it is not possible (or not possible without serious risks) to sterilise kits comprising pre-filled syringes in a single sterilisation operation.

Packaging the kit in this way is labor intensive and also risks damage to the externally provided pre-filled syringe during storage and transport of the kit.

However, those skilled in the art will recognize that the approach disclosed in WO2005 / 073091 does not fully address the problem of the ingress and retention of potentially toxic residual sterilizing gas (or contaminants thereof) as such material could remain present within the container and indeed would be trapped therein upon removal of the gas permeable portion of that container.

Further, one skilled in the art will also recognize that the construction of the container will be challenging, resulting in either an increase in the complexity of the manufacture of the container, or (if sourced from a third party supplier) an increase in the cost of each sterilization cycle.

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