3.3.1 Fit-for-purpose working environment
A. Background & Definitions
The working environment must be appropriate to ensure adequate and safe working practices and to minimize disturbance that would interfere with the validity of the study.
B. Guidance & Expectations
- Experimental rooms must be suitable to meet the requirements of the study.
- Storage rooms for samples, reagents, supplies and equipment should provide adequate protection against deterioration or contamination. Safe storage for hazardous substances should be ensured.
- Animal housing should be performed under controlled conditions (see 188.8.131.52 Animal environmental conditions).
- Handling and disposal of wastes should be carried out in such a way as not to jeopardize the integrity of studies (collection, storage, decontamination, transportation).
- Archiving conditions should protect contents from untimely deterioration.
Extra care has to be taken:
- Where important, environmental parameters such as temperature and humidity should be monitored and acceptance ranges should be defined.
- Where appropriate, there should be contingency plans in case of power failure or other disruption.
- Where special facilities are used they must be regularly checked and maintained (e.g. fume cupboards, heating, ventilation and air conditioning (HVAC), cold rooms).
PLEASE DO NOT FORGET
- Keep maintenance records of special facilities (e.g. fume cupboards, heating, ventilation and air conditioning (HVAC), cold rooms).
- In case of suboptimal working/storage environment conditions (e.g. acceptance ranges for temperature or humidity are exceeded) this should be documented in the study along with impact assessment.
- Any regulations that define additional standards associated with specific laboratory hazards (e.g. ionizing radiation, controlled substances, biohazard, animal allergens) must be adhered to.
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