TRAINEE - World Health Organization

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Chapter 2 • GLP Training Manual <strong>TRAINEE</strong>S Separation ensures that different functions or activities do not interfere with one another or affect the study, and minimizes disturbances. This can be done by: – physical separation, for example, walls, doors or filters. In new buildings, or those under conversion, separation will be part of the design. Otherwise separation can be achieved by the use of isolators, for example. – separation by organization, for example carrying out different activities in the same area at different times, allowing for cleaning and preparation between operations, or maintaining separation of staff by establishing defined work areas within a laboratory. As an illustration of the principles involved we shall consider: • Areas concerned with test material control and mixing with vehicles (although the same considerations would apply to other areas such as analytical or histopathology laboratories). • Animal facilities. Pharmacy and Dose Mixing Areas The pharmacy and dose mixing area is a laboratory dealing with test item workflow: receipt, storage, dispensing, weighing, mixing, dispatch to the animal house and waste disposal. Size The laboratory is big enough to accommodate the number of staff working in it and allow them to carry on their work without risk of getting in each other’s way or mixing up different materials. Each operator has a workstation sufficiently large to be able to carry out the operation efficiently. There is also a degree of physical separation between the workstations to reduce the chance of mix-up of materials or cross contamination. The pharmacy is a sensitive area and, to such facilities, access should be restricted so as to limit the possible contamination of one study or compound by another. Construction The laboratory is built of materials that allow easy cleaning and are not likely to allow test materials to accumulate and cross contaminate others. There is a ventilation system that provides a flow of air away from the operator through filters, which both protects personnel and prevents cross contamination. Most modern dose mix areas are now designed in a “box” fashion, each box having an independent air system. 25
26 <strong>TRAINEE</strong>S Chapter 2 • GLP Training Manual Arrangement There are separate areas for: – storage of test item under different conditions – storage of control item – handling of volatile materials – weighing – mixing of different dose forms e.g. diet and liquid – storage of prepared doses – cleaning equipment – offices and refreshment rooms – changing rooms. Animal Facility To minimize the effects of environmental variables on the animal, the facility should be designed and operated to prevent the animal coming into contact with disease, or with a test item other than the one under investigation. Requirements will be different depending upon the nature and duration of the studies being performed in the facilities. Risks of contamination can be reduced by a “barrier” system, where all supplies, staff and services cross the barrier in a controlled way. A typical animal house would have separation maintained by provision of areas for: – species – studies – quarantine – changing rooms – receipt of materials – storage - bedding and diet - test doses - cages – cleaning equipment – necropsy – laboratory procedures – utilities – waste disposal.
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TRAINEE - World Health Organization

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