Undergoing inspections and audits is a harrowing experience. Before the FDA, EPA, or other regulatory agency inspectors visit, you need to form an Inspection Team within your company. When the inspector arrives, making a good impression sets a positive tone because...
What is environmental monitoring?
Environmental monitoring describes the systems that allow pharmaceutical manufacturers to monitor and control the viable, non-viable, and environmental contamination in their cleanrooms. The environment of manufacturing and material/product storage is stored crucial. Specific regulations have to be met for your product to maintain its viability. When preparing your facilities’ production room and storage areas, environmental monitoring should be discussed. Environmental monitoring consists of temperature monitoring, particle counts, and microbial testing (to check the cleanliness of the room). For example, let’s say a new manufacturing room has just been constructed, cleaning has been done, and manufacturing is ready to start. But first, let’s make sure the room is within specification by temperature mapping, particle counts, and microbial testing.
The following process can be put into your environmental monitoring standard operating procedure (SOP) to minimize any issues with compromising your product:
- Standard Operating Procedure – Have in place a procedure describing how your environmental monitoring will be conducted. The SOP details when monitoring happens, how many times (a schedule), and what will occur each time. These specifics will vary if the room is for manufacturing or storing. It’s good to create a form for each testing to keep good records. Have a section on what to do if there is an excursion from the specifications.
- Temperature Mapping – temperature devices are spread out evenly throughout the room, and the temperatures are logged at specific intervals and for a certain period. This procedure ensures that the temperatures are within range continuously across the environment.
- Particle counts – This process uses a particle counter to determine the number of particles in the air inside the room.
- Microbial Sampling– This is the process of making sure that cleaning within the rooms is being done correctly. Microbial sampling indicates how many different microbes are growing within the room. Surface testing involves touching agar plates on areas such as tables, equipment, and walls to test for bacterial growth. Air sampling is performed by leaving agar plates in different parts of the environment for a defined period. The standard operating procedure should state what qualifies as passing and failing the environmental monitoring test.
Authored by Ashley Castro, PSC Biotech® consultant
Edited by Crystal McClain, PhD
PSC Biotech® has engineers and professionals to assist with Environmental Monitoring. As a global leader specializing in Engineering consulting services, PSC Biotech® works to ensure life sciences companies’ processes are functional and fully compliant with FDA and EMA guidelines. Our goals are to provide tailored professional services, act as a seamless extension of life science companies, assist you in producing the highest quality products possible, and ensure processes are functional and in full compliance. Also, see our equipment rentals section for CLiMET® particle counters and air samplers and more!
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