Gloves aseptic handling

In chapter Aseptic handling (see Sect. 31.5) product protection results in single gloving and change after 30 min or earlier when damaged. 

Before any aseptic activity, hands should be thoroughly washed and disinfected, usually with an alcohol-based gel. The skin flora is both transient and resident. Resident flora is difficult to remove, so it is recommended to always use gloves within the clean room suite. Whilst carrying out aseptic handling in a Grade A environment, sterile gloves are required. 

Ordinarily, present within the preparation area are localized areas of ISO 5 unidirectional airflow (Class 100) utilized to protect washed components prior to sterilization and/or depyrogenation. These areas are not aseptic and should not be subjected to the more rigorous microbial expectations of aseptic processing. They are designed to reduce/eliminate the potential for particle contamination of unwrapped washed materials. Operators accessing these protective zones wear gloves at all times when handling materials. 

Handling of retrieved implants and tissues may pose safety concerns for laboratory personnel. As a precautionary measure, retrieved implants should be sterilized and disinfected carefully. In cases where implants cannot be sterilized prior to analysis due to protocol requirements, extreme care should be taken to use an aseptic technique. Barrier clothing, gloves and biosafety cabinets should be used. A detailed discussion of precautions to be used in handling of human tissues can be found in ISO 12891-1. 

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