Environmental monitoring is an essential part of maintaining the quality of products manufactured in controlled environments such as pharmaceutical facilities. It involves the collection and analysis of samples from various locations within the facility to detect the presence of microorganisms and other contaminants that could compromise product quality or safety.
Settle plates and contact plates are common methods used in environmental monitoring to collect microbial samples from the air and surfaces, respectively. Settle plates are petri dishes that are placed in the environment for a specific period to allow the airborne microorganisms to settle on the surface of the plate. Contact plates are similar to settle plates, but they are used to collect microbial samples from surfaces. Contact plates are pressed onto a surface for a specific period to transfer any microorganisms present on the surface to the plate’s surface. The plates are then incubated under controlled conditions to allow the microorganisms to grow and are then read by a professional microbiologist, providing information about the types and quantities of microorganisms present in the environment. Vivariant provides clients with incubation and analysis services for settle and contact plates at our GMP and ISO 17025 laboratory. Clients can either buy their own plates, or buy plates from us, collect their samples and send the plates to us for incubation and analysis.
In addition to settle plates and contact plates, water testing is another critical component of environmental monitoring in controlled environments. Water can serve as a source of contamination that can compromise the quality of the products being manufactured. One common water testing method used in these environments is the measurement of the total heterotrophic plate count (THPC) using membrane filtration. Membrane filtration involves filtering a known volume of water through a membrane filter with a pore size small enough to capture bacteria. The filter is then placed on a nutrient-rich agar plate and incubated for a specific period to allow any bacteria present on the filter to grow. The resulting colonies are then counted to determine the THPC, which is a measure of the number of bacteria that can grow on the nutrient-rich medium. Water testing may also include testing for the absence of specific pathogens such as Pseudomonas aeruginosa, which can cause infections in humans and can be found in water sources. Detection of Pseudomonas aeruginosa in water can be achieved using culture-based methods. Vivariant can perform these microbial analyses for environmental monitoring of your facility’s water supply.
By monitoring the environment regularly using methods such as settle plates, contact plates, and water testing, trends in the data can be identified, allowing for early detection of potential issues and proactive measures to be taken to prevent contamination and maintain product quality. The data obtained from environmental monitoring in controlled environments are used to assess the cleanliness of the facility and to identify any potential sources of contamination. This information is then used to implement corrective actions to prevent contamination, maintain product quality, and ensure compliance with regulatory requirements.
Contact us to learn how we can assist you with your organization’s environmental monitoring program.