In isolator processes requiring manual control, workers can typically gain access to the products within the enclosure through the use of a half-suit or glove ports.
The half-suit is an airtight protective garment attached to a sterilized isolator chamber and can normally be entered from below, while glove ports are airtight sleeves into which technicians can place their arms and hands in order to physically manipulate an isolator product or sterilized instruments.
These manual access systems are often necessary even in automated isolator operations because isolator equipment may require maintenance, adjustments, or repair during production runs. In general, manual access through the glove ports should be kept at a minimum because glove failures, such as rips or pinhole openings, present the most common risk of contamination for sterilized materials.
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