Chemical Hygiene Plan and Safety Manual - LP3014.2 Laboratory Accommodations and Environmental Conditions

4.1.4.1 The microbiological testing department will be physically separated from all other testing to prevent cross-contamination and access to department will be limited.

4.1.5 To ensure the safety of all visitors, access to the laboratory is controlled and limited. LP3002 Chemical Hygiene Plan and Safety Manual Section II: General Laboratory Safety details laboratory access.

4.1.6 Purity will have separate storage areas for test samples, references (including positive controls and standards), and chemicals, media, and reagents. Samples should also not be handled or stored in the same area that controls or standards are being prepared. Media should also not be prepared or stored in the same area as positive controls.

4.1.6.1 Procedures regarding the storage, handling, and disposal of chemicals, media, and reagents can be found in LP3001 to LP3012 Chemical Hygiene Plan and Safety Manual.

4.1.6.2 See LP2005 Test Sample Storage, Retention, and Disposition for procedures regarding test samples.

4 2 Environmental Conditions

4 2 1 Purity will ensure that the environmental conditions do not invalidate the testing results or adversely affect the required quality of any measurement

4 2 2 This will be done by controlling, monitoring, and recording environmental conditions as required by relevant specifications, methods, and procedures, or where they influence the quality of the results Environmental conditions include, but are not limited to: biological sterility, dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, and sound and vibration levels

4.2.3 When a test method or procedure spells out specific environmental conditions for the conduct of an analysis, the measures taken to resulting data defining conditions recorded. Environmental conditions will be monitored either directly or indirectly as needed by the test method or procedure.

4.2.3.1 Direct measurements are documented within the original observations or in a logbook dedicated to such measurements.

4.2.3.2 Indirect measurements include quality control samples, such as certified reference materials or spikes.

4.2.4 Environmental conditions will be monitored at frequencies according to test method or procedures. Activities will be stopped if conditions could be detrimental to an analysis. If equipment or analysis is performing within acceptable ranges, the conditions are considered acceptable.