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Ensuring clean manufacturing conditions to maintain drug quality, efficacy, and the safety of patients.
Eurofins BioPharma Product Testing New Zealand offers comprehensive environmental monitoring services to ensure safety and compliance in pharmaceutical manufacturing environments, focusing on pathogen control and Good Manufacturing Practices (cGMP)
Environmental monitoring 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 effective environmental monitoring, and should be specified in the written programme or standard operating procedures. This is one area that we can work closely with our clients to develop.
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 gives a measure of the sedimentation of contaminants over time.
Surfaces
These can be examined 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.
Would you like to find out more about our testing solutions, or do you need tailored analytical support? Contact us today to get in touch with our experts.