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There are constant challenges that need to be addressed in Life Science industries. Intense competition, cost increases, strict regulatory and safety requirements are just some of the many difficulties that innovative companies must continuously address in order to develop, produce, and deliver products to market.

 

Environmental Monitoring

 

Environmental monitoring in life science industries is an important component in overall processes to ensure products are fit for market and that quality standards for regulatory compliance are met. In laboratories, clean rooms, operating theatres, blood banks and many other areas, having a comprehensive environmental monitoring strategy is imperative to an organization’s success.

 

“A well developed Environmental Monitoring program is a proactive way to assure the cleanliness of the facility is maintained.”

 

What is Environmental Monitoring?

 

Environmental monitoring in a lab is the measuring of ambient conditions--room temperature, relative humidity, air quality and more--in order to maintain a constant state of control over laboratory conditions. Sensors are installed throughout a facility and on specific equipment to monitor pertinent variables and provide immediate alerts in the event there are any deviations from preset parameters. These real-time notifications provide scientists and researchers with the time necessary to take corrective action and minimize risks.

 

Why is Environmental Monitoring Important?

 

Maintaining control over laboratory environments and equipment is necessary to successfully replicate research results, substantiate scientific discoveries, and prove compliance with regulatory authorities. Airborne particles, changes in room temperature or humidity, and even pressure differentials introduce new variables to controlled, scientific environments. If research results differ, sample integrity is compromised, or a particular patient procedure results in complications, it is necessary to prove an in-depth understanding of environmental conditions backed by relevant data, how conditions influence processes, and what measures are being taken to control all ambient parameters.

 

Why is Environmental Monitoring Difficult?

 

Difficulties with environmental monitoring can be in determining what it means for your organization, what solutions to implement, what benefits there are, and how to address challenges when they come. There are many different methods to environmental monitoring. These can include monitoring for: temperature, relative humidity, differential pressure, particle counting, O2 and CO2, volatile organic compounds (VOCs), and many others. In any event, minimizing risks and costs, while maximizing efficiencies and operations should be at the forefront for any life science environmental monitoring program.

 

Areas and Rooms for Environmental Monitoring:

 

  • Manufacturing Areas

-GMP Environments require strict monitoring

  • Clean Rooms (3 classifications for clean room facilities)

1) ISO 5 (Grade A)

2) ISO 7 (Grade C)

3) ISO 8 (Grade D)

  • Vivariums

-Monitoring for optimal conditions is key for animal research

  • Drug Fill/Finish Areas

-Monitoring protects against potential contamination

  • Formulation Rooms

--Surface monitoring ensures proper conditions for formulation

 

Equipment and other considerations for Environmental Monitoring:

 

  • Laminar Flow Hoods
  • Biological Safety Hoods
  • Isolators
  • Glove/Protective Equipment Storage
  • Packaging Areas

 

 

If you'd like to learn more about implementing an environmental monitoring strategy, schedule a free consultation Today

 

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