When to use sterile gloves and other sterile consumables for the cleanroom?

Sterile gloves and other sterile consumables for the cleanroom are used for a variety of different applications.

In the following article, we first explain exactly what sterile means, when sterile consumables – including sterile gloves – are needed in the cleanroom and which sterile consumables are available to buy in the online store of the Swiss cleanroom specialist wholesaler abovo.

What exactly is sterile?

Sterile refers to the property of materials or their surfaces, for example, in which almost all microorganisms have been killed using a sterilization process. In practice, 100% sterilization is generally not possible. Rather, the aim of sterilization is usually to ensure that the surviving microorganisms remain below a certain limit. Microorganisms include bacteria, fungi, viruses, prions and algae.

There are three types of sterilization process in particular: Gamma sterilization, autoclaving and gassing with ethylene oxide. For sterile gloves, however, it is not only sterilization that is decisive, but also the so-called AQL value (Acceptable Quality Level), which is stricter for sterile gloves than for non-sterile gloves. The AQL value for sterile gloves may only be between 1.0 and 1.5 AQL.

Aseptic techniques and pure cleanroom techniques in particular must be distinguished from sterile techniques. While sterile refers to an object being almost 100% free of microorganisms, aseptic technology refers to the creation of conditions that ensure that the object remains sterile.

In contrast to sterile objects, exclusively cleanroom-compatible objects are objects that fulfill the requirements for a specific cleanroom class, i.e. with regard to the particle contamination emanating from these objects, but are not sterile themselves.

When do you need sterile consumables in the cleanroom?

The question of when sterile consumables – such as sterile gloves – are required in the cleanroom depends on the particular application that is being carried out in the cleanroom. Companies operating in the medical technology, biotechnology or pharmaceutical industries in particular generally require sterile consumables in the cleanroom.

For example, if a pharmaceutical company produces drugs such as infusions or vaccines in a clean room that are to be administered to a person’s body, they must be manufactured under sterile conditions in order to prevent human illness caused by microorganisms. The same naturally also applies to medical technology manufacturers who produce prostheses or implants that are operated on in a person’s body.

In some cases, there are also legal requirements and guidelines relating to sterile production processes. One of these guidelines is EU GMP Annex 1, an annex to the European Union’s guidelines for “Good Manufacturing Practice (GMP)”. In particular, EU GMP Annex 1 regulates the requirements and recommendations for the manufacture of sterile medicinal products.

For more information, please read our article “New EU GMP Annex 1 requires contamination-K ontrol Strategy (CCS)“.

In certain application cases, double gloving should even be used, for example when handling cytostatics.

When you do not need sterile consumables

However, there are also many areas in which sterile consumables are not required, for example where sterile gloves do not need to be used and cleanroom gloves are sufficient. This is the case, for example, if the work to be carried out in the cleanroom is only about reducing particle contamination and protecting the user, i.e. the employee, when they are working with certain chemicals.

However, when selecting a glove, it is important to ensure that the glove is sufficiently resistant to the chemicals used in the work. In order to meet the requirements of the respective cleanroom conditions, it is also important to ensure that the glove is suitable for the respective cleanroom class.

Buy sterile consumables

In the abovo online store, customers can choose from a large selection of s terilen cleanroom productsn are available, including many sterile consumables:

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Advice on sterile consumables

If you need support in selecting sterile consumables that are suitable for your application, our cleanroom experts at abovo will be happy to help you.

The best way to contact the cleanroom experts at abovo is by telephone or e-mail: