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 manufacturing and storing of your product is an enormous undertaking for a company. The product is the bread and butter of the company, and the environment that it is manufactured in and stored in has to be impeccable and within its regulations per GMP (Good Manufacturing Practice). Several issues could arise if the environmental specifications are not met. Your product could be stored in a room where the temperature became too high for an extended period. There could be a significant amount of microbial contamination within a manufacturing room that was supposedly cleaned. There could be too many particles floating in the air as well. Any of these issues could mean loss of the product and timing complications in getting your product out because now more testing needs to be conducted to ensure that the product wasn’t compromised. If you have a system of checks, the environmental compromises become minimal.
Environmental monitoring clean room

Best Practices

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.
Make sure to create forms for each test and to make sure and explain what the plan of action is if there is a failure in the room. Environmental monitoring is a vital part of your manufacturing. Putting this in place is a part of the success of the company. It is another way to keep the product from being compromised.

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! 

We look forward to hearing about your needs in Engineering and whether we can be of service. Please get started by emailing us at info@biotech.com or using our contact form online.

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