Air, Surfaces and Personnel Sampling
Environmental Monitoring (EM) allows you to examine the conditions under which work is conducted and to investigate any contamination incidents. In GMP environments it is conducted to demonstrate that the manufacturing environment is under control.
Sampling locations and adequate sampling are critical components of an effective EM and should be specified in the written program or standard operating procedures. This is one area that we can work closely with our clients to develop.
There are several components involved in an EM program.
• Air (Passive and Active): Air quality can be determined by either active (direct) sampling, in which a given volume of air is examined using a sampling machine, or by passive sampling using settle plates which give a measure of the sedimentation of contaminants over time.
• Surfaces: can be examined in either with surface swabs or contact plates
• Personnel: In some clean room operations it is necessary to take samples of operators hands (finger dabs) or protective clothing to monitor gowning effectiveness and hand cleanliness.