Workers in cleanrooms and laboratories wear single-use gloves to protect themselves, mainly against chemical and biological risks during handling, but also to protect their work and industrial processes. In some environments or industries, in cleanroom and laboratories, it may be necessary to double-glove, it means wearing two pairs of single-use gloves one on top of the other. This is referred to as double-gloving. These gloves may be made of nitrile or latex and may be sterile or non-sterile. Why double-glove in cleanrooms and laboratories? Whether to protect the worker or to ensure that the manufactured product is not contaminated, it is important to choose the appropriate gloves and follow the double-gloving procedure.
In these environments, and after carrying out risk assessment, appropriate measures for prevention and the protection of staff, both collective and individual, must be implemented. The nitrile gloves or latex gloves used in these working environments must be:
Gloves provide a protective barrier when handling hazardous materials (infectious, toxic) or equipment potentially contaminated with these materials, infected animals, etc. Gloves can also deteriorate during handling by the operator and may no longer provide sufficient protection. Therefore, doubling laboratory gloves reduces the deterioration of the inner glove (the one in contact with the skin) and ensures better protection for the operator.
The use of (sterile or non-sterile) single-use gloves constitutes the first line of protection for operators handling chemotherapy products. Since the gloves are therefore intended to protect the wearer, they must be registered in accordance with (EU) Regulation 2016/425 on Personal Protective Equipment (PPE). This regulation concerning PPE differs from that concerning medical devices ((EU) Regulation 2017/745).
Since some cytotoxic products have a high penetration power and, in general, these products have a toxic effect on human cells, double-gloving with sterile gloves is particularly recommended during the production and preparation phases, in order to obtain a total thickness of at least 0.2 mm to 0.3 mm (according to the local reference standard). This is because it is unlikely that any micro-holes will be present on both pairs of gloves and in the same places. In general, sterile gloves should be changed regularly (approximately every 30 minutes to one hour or every 4/5 operations) to avoid skin contact.
Sterile medicinal products are manufactured in a Controlled Atmosphere Zone (CAZ) in compliance with good manufacturing practices (GMPs). In these areas, the risk of particulate and microbial contamination of products must be minimized. The first reason for wearing gloves in these areas or, more generally, in cleanrooms, is therefore to avoid product contamination. This is because any detected contamination would lead to both the loss of the manufacturing batch and therefore financial losses. If contamination were not detected, the risks to the consumer would be significant and the consequences for the manufacturer potentially severe.
Sources of contamination:
It is therefore essential to maintain the cleanliness of cleanroom environments by wearing gloves of a high level of cleanliness with a low particle content and which are long enough to cover the wrist of the suit.
Double-gloving ensures that the aseptic environment (Class A or B) is maintained by adhering to clothing procedures that require the wearing of ultra-clean sterile gloves before putting on a complete set of sterile garments, including a second pair of sterile cleanroom gloves.
Furthermore, in life sciences and in many environments, it is very common to have to carry out regular disinfection of outer gloves (those not in contact with the skin) using products such as 70% Isopropanol. This successive spraying or wiping with pre-saturated wipes (approximately every two minutes or after each critical action) causes the gloves to deteriorate. It is therefore necessary to change outer gloves regularly. Wearing two pairs of sterile gloves means that only the outer glove has to be changed without leaving the workspace. Any exit involves a complete, time-consuming, and therefore costly undressing and dressing procedure.
SHIELD Scientific offers several glove combinations for use in a double-gloving procedure:
The most common combinations of double-gloving sterile gloves for activities in aseptic production areas:
The most common combinations of double-gloving non-sterile gloves for biosecurity laboratory activities:
In conclusion, Health & Safety, Production, Quality and Sterility Managers and users of disposable gloves need to consider a number of factors when choosing the right protective laboratory or cleanroom gloves to meet the objectives set. Double-gloving ensures the safety of workers, products and the environment while maintaining comfort and dexterity. Gloves that are easy to put on and take off are an additional factor in productivity and safety.
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Categorised in: Glove education
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