Environmental Monitoring in Pharmaceutical Industries, What is it and what is it for?
Environmental monitoring is a control that uses some sequences of measurements and parameter indicators, aiming at the preservation of our natural assets such as air and water.
Its functions include measurements, research, inspections and observations, with a view to collaborating for the preservation of these assets.
These parameter indicators (defined by ANVISA) collaborate to verify possible contamination and environmental impacts. Dimensions and risks are measured, and, in the case of occurrences, verification is made of what measures should be taken in order to minimize damage. In addition to evaluating the efficiency of preventive measures for each environment.
How does environmental monitoring work in the pharmaceutical industries and what is its importance in these environments?
First, it is important to understand that there are 2 types of environmental monitoring. They are micro and macro scale.
When we think of environmental monitoring in classified areas, such as in the pharmaceutical industry, we are talking about micro-scale environmental monitoring, as these are relatively small areas and parameters with pre-defined space limits. And it is precisely this monitoring that we are going to deal with…
In pharmaceutical industries and critical environments, air treatment is necessary, as possible contamination through the air can harm the entire drug manufacturing process. Contaminating from its formula, to the workplace and the people who will consume these medicines.
To protect the environment, tests and measurements are needed to control the risk of contamination by microorganisms in industrial sectors.
Through tests such as counting particles present in the air, and verifying the emission of gases generated in these industrial processes, it is possible to conclude which preventive measures (related to air treatment) will be taken to mitigate risks in that environment.
Within the same pharmaceutical industry, there will be different areas that will be separated and classified according to the degree of risk (defined by legislation) of each of these environments, taking into account the processes carried out there.
According to the degree of risk in the area, it will be classified as Grade A, B, C or D. The type of preventive action in the treatment of the air will also be defined, aiming at quality and the reduction of risks in the environment.
A safe production line is all about strict monitoring parameters!
Grade A areas are areas that require maximum environmental control to avoid contamination.
The Clean Rooms (remember the concept of Clean Rooms by clicking here) are examples of environments that must be highly controlled, therefore considered as a Grade A area, so the air treatment that this place will receive will be different from other areas of this same industry such as: pharmacies, corridors, changing rooms, etc.
Grade B areas are those that are close to or next to Grade A areas. They also require stricter control, as if contaminated they can expand contamination to Grade A rooms.
Grade C and D areas are more tolerant to microorganisms. Generally places where non-sterile products are handled, therefore they do not require great environmental control.
Each degree variation will define a different type of action. As well as the use of filters in the air treatment process will be according to the degree of purity required in the environment.
Air Filters in the Pharmaceutical Industries
Os air filters plays an important role in environmental monitoring.
They are the filters that will control the propagation of airborne contaminants such as bacteria, fungi, parasites, among others. In this way avoiding damages such as:
- Contamination of drug batches
- Severe damage linked to the health of all people involved in the drug manufacturing processes
- Damage to the health of the final consumer.
To keep production safe, pharmaceutical industries need a system of air treatment safe and effective.
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