Everyone is familiar with disposable gloves, but very few are familiar with the fact that these disposable gloves are of two types, which are
- Sterile Gloves
- Non Sterile Gloves
This classification of disposable gloves is based on FDA (Food and Drug Administration) requirements & in this article, we will discuss the basic difference between the sterile and non-sterile gloves.
What is Sterility?
Before going into details of sterile gloves vs non-sterile gloves, you must be familiar with the term sterile or sterility.
Sterility is the absence/complete removal of microorganisms.
What Are Sterile Gloves
Sterile gloves are those gloves which are sterilised to ensure removal of microorganisms & meet the sterility assurance level (SAL) of 10^-6.
The SAL of 10^-6 indicates that there is less than one chance in a million for the presence of one microorganism.
The sterile gloves also meet strict Acceptance Quality Level (AQL) for pinhole & value falls between 1 to 1.5% for pinholes.
Material of construction for sterile gloves
The following materials are used for the manufacuring
- Rubber
- Latex
- Nitrile
- Vinyl
When To Use Sterile Gloves
- The use of sterile gloves is mandatory in the pharmaceutical industry for the manufacturing of sterile products.
- The sterile gloves are required for working in ISO class 5 and ISO 6, or in simple terms in Grade A and Grade B in pharma.
- For handling of sterile components.
Example
- A common example is to wear the sterile gloves during the filling and sealing of ampoules under laminar air flow.
- Sterile gloves are used in other health care facilities, like in hospitals, during surgery.
Sterilisation of sterile gloves
The sterile gloves are sterilised by the manufacturer, and a certificate of irradiation (COI) is also provided by the manufacturer when it is sterilised by gamma rays.
Gloves are also sterilised by Ethylene oxide gas.
Packaging Of Sterile Gloves
The sterile gloves are not packed in bulk rather, they are packed in individual packets after sterilisation to maintain their sterility assurance level.
Benefits Of Sterile Gloves
- Sterile gloves are free from microbes & prevent microbial contamination of sterile products.
- These are free from powders to ensure product safety.
Non Sterile Gloves
As the name indicates, the non-sterile gloves are not sterilised. The non-sterilised gloves are made from exactly the same material from which sterile gloves are manufactured, but the difference lies in the process of sterilisation.
Non-sterile gloves are not sterilised because they are not used to handle sterile products or surgical procedures.
Non-sterile gloves also follow FDA standards other than SAL.
AQL For Non Sterile Gloves
AQL for pinholes of these gloves is 1.5 to 2.5%.
Packaging Of Non-Sterile Gloves
As we don’t require sterility so these gloves are packaged in bulk.
Price Of Non-Sterile Gloves
Non-sterile gloves are cost-effective because gamma rays or any other sterilisation process is not used for these gloves.
When To Use Non-Sterile Gloves
- Non-sterile gloves are used during work in grade C or D.
- For non-surgical procedures.
- Handling food.
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