Considerations in selecting arm protection for vaccine manufacturing
Vaccine production dates back to the 1700’s. Today thankfully, vaccines are commonplace and highly effective. With the recent SARS-CoV-2 outbreak, many have benefited directly from this life-saving technology.
Vaccine production can present serious risks to patients if not managed carefully. The manufacture of vaccines and similar biologics are carried out in ISO Class 5, Grade A environments. This means that not only must the area be mostly free of particles, but also effectively sterile. Constant vigilance and process control is critical as contaminants can still be introduced into these cleanrooms, usually coming from bulk material and equipment, but primarily from cleanroom operators. (1)
Below are the considerations to make when selecting gloves for vaccine manufacturing:
Length of gloves
300mm (12”) length gloves still remain the most widely used length of gloves in sterile environments today. The trend, however, is shifting to a 400mm (16”) length glove. Many regulatory agencies stress the need to provide adequate forearm coverage by properly overlapping gloves on the gown sleeves. A 400mm (16”) glove ensures that the entire forearm is covered thereby reducing the risk of skin exposure. A longer length, depending on material and thickness, may also provide protection to operators who work with harmful chemicals or pathogenic strains.
- Smooth inner glove
If you are double gloving, you need to ensure that the 1st pair (inner pair) of gloves you put on has a smooth outer surface to aid the donning of the 2nd glove on top.
- Length of inner glove and outer glove
A 300mm (12”) glove is commonly used as the inner glove while a 400mm (16”) glove is used as the outer glove to provide maximum coverage. In many instances end users may also choose a 400mm (16”) inner glove as well as a 400mm (16”) outer glove.
- Sterility of gloves
This decision depends on each company’s SOP. Some companies will have a protocol which mandates a non-sterile inner glove (sanitized with some form of alcohol or sporicidal biocide), with a sterile glove on top, or simply one sterile glove on top of another sterile glove.
Using contrasting inner and outer gloves helps operators to visually detect punctures or tears triggering an immediate glove change to avoid any contamination risk.
Glove polymer coating
It is imperative to ensure that gloves selected for vaccine manufacturing are not polymer coated. Polymer coated gloves will generate particles contributing to process contamination when used. Opt for gloves from your suppliers that have been chemically treated to make them smooth and powder-free as this process leaves no residues or loose particles which can be introduced into your cleanroom.
Also important: sterility
As vaccine manufacturers, it is critical to validate the sterility of the gloves which you have received from your suppliers. Request from them documents which prove the sterility of the product, in particular the sterility validation file. Ensure that suppliers are also able to provide routine dose audit documents for the gloves to ensure the glove you are using are still appropriate regardless of the regularity of their production (2)
Isofield manufactures 600mm (24″),400mm (16″) and 300mm (12″) sterile gloves which are suitable for use in aseptic / sterile environments (Grade A/ISO Class 5). We can guide you in the selection of the suitable hand and arm protection after considering your processes and systems. Get in touch with us to find the right gloves for your vaccine manufacturing.
- “Environmental Monitoring of Clean Rooms in Vaccine Manufacturing Facilities: Points to consider for manufacturers of human vaccines.” <https://bit.ly/vaccinequality>. Accessed July 5, 2021.
- “Method 1 Quarterly Dose Audits: Interpretation Of Results” <https://www.steris-ast.com/techtip/method-1-quarterly-dose-audits-interpretation-results/ >. Accessed July 5, 2021