Heat sterilization techniques for chlorhexidine based antiseptic formulations
Inventors
Margoosian, Razmik • Afarian, Viken
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-9724437-B2
Publication Date
2017-08-08
Expiration Date
Abstract
Techniques for sterilizing chlorhexidine based antiseptic formulations include exposing a sealed container containing the formulation to heat at a temperature and heating time sufficient to sterilize the chlorhexidine based antiseptic formulation and the hermetically sealed interior of the container, which may be an applicator, a bottle, a swab stick, or a pad-containing pouch.
Core Innovation
The invention relates to a process for preparing and sterilizing a chlorhexidine based antiseptic formulation and a container for medical use by adding the chlorhexidine based antiseptic formulation into a container, hermetically sealing the container to form a hermetically sealed interior, and exposing the sealed container to heat. The heat sterilizes both the chlorhexidine based antiseptic formulation and the hermetically sealed interior, and sterilization of the chlorhexidine based antiseptic formulation and the hermetically sealed interior consists of the heat sterilization.
The process applies to chlorhexidine based antiseptic formulations including chlorhexidine gluconate (CHG) formulations and includes sealed containers with a sealed interior that includes headspace. The heat treatment targets the formulation as well as the sealed interior and headspace, including vapor regions, to achieve sterilization of interior surfaces even when the interior is not directly contacted by the formulation.
The invention further includes determining sterilization conditions for the heat sterilization using a sterility-tested detection tab associated with the sealed interior. In representative embodiments, the formulation and the hermetically sealed interior are treated under defined temperature and heating time conditions, and an example is provided in which CHG/isopropyl alcohol/water in sealed containers treated at specified conditions achieved sterilization of non-direct-contact interior surfaces.
Claims Coverage
The relevant independent claim establishes one inventive process that adds a chlorhexidine based antiseptic formulation to a hermetically sealed container and heat sterilizes both the formulation and the hermetically sealed interior, where sterilization consists of the heat sterilization. The claim coverage also includes related inventive features for formulation ranges, heating conditions, container structure, and validation of sterilization conditions.
Heat sterilization of hermetically sealed interior with chlorhexidine formulation
A process comprising adding a chlorhexidine based antiseptic formulation into the container; hermetically sealing the container to form a hermetically sealed interior; and exposing the sealed container to heat at a temperature and heating time sufficient to effect heat sterilization of the chlorhexidine based antiseptic formulation and the hermetically sealed interior, wherein sterilization of the chlorhexidine based antiseptic formulation and the hermetically sealed interior consists of the heat sterilization.
Chlorhexidine gluconate content range
The chlorhexidine based antiseptic formulation contains about 0.5% w/v to about 5% w/v chlorhexidine gluconate.
Isopropyl alcohol concentration range
Isopropyl alcohol is present in the chlorhexidine-based antiseptic formulation at a concentration between about 55% v/v and about 80% v/v.
Liquid applicator with sealed container body and absorbent head
A liquid applicator includes a sealed container body and an absorbent head that breaks part of the container to allow a chlorhexidine-based antiseptic formulation to flow into and through the absorbent material for application.
Determining sterilization conditions using a sterility-tested detection tab
Sterilization conditions are determined by adding the chlorhexidine-based antiseptic formulation to a container, applying and sealing a detection tab, exposing it to specified temperature and heating time, removing the tab and testing it for sterility, and deciding whether the conditions are sufficient to sterilize both the formulation and the container inner surfaces.
The inventive coverage centers on heat sterilizing a chlorhexidine based antiseptic formulation together with the hermetically sealed interior, including headspace and vapor regions, using heat sterilization alone, with further refinements for CHG and isopropyl alcohol composition ranges, defined heating conditions, specialized container structures, and validation with a sterility-tested detection tab.
Stated Advantages
Documented Applications
No documented applications found
Interested in licensing this patent?