Pharma products are produced under strictly controlled conditions. They must be stored, handled, and transported under ideal conditions. It is essential to ensure the safety of drugs. For this, processing areas must be free from contamination. Microbial data collection and analysis play a critical role in ensuring the quality of such conditions. This data comes from samples of surfaces, air, water, and personnel in a clean space.
Environmental monitoring (EM) is a process that helps monitor sterile and non-sterile drug products. EM provides data on the quality of the environment during batch manufacturing. It gives an insight into the contaminants present in the processing environment. It helps identify potential contamination routes. It also indicates an action plan when levels are exceeded. Trend analysis of environments further improves lab processes. The plan helps analysts check on the effectiveness of common processing steps such as cleaning, gowning, housekeeping, etc.
The Scope
Monitoring can prevent the risk of contamination at various levels. Certain vaccines and injectables are prepared in aseptic environments, also called controlled environments. These environments must be appropriately monitored as per the pharma regulatory guidelines.
With major focus on air, surfaces, people, and water, gas, media, culture, and equipment also must be monitored. Each EM system is unique to process, plant, and product.
The Benefits
A robust EM system notifies any breakdown in the control measures. A clear policy of the level of microorganism to be identified can allow for better control of the environment. A digital environmental monitoring system,
- Provides crucial data on the environmental quality of processing areas
- Helps identify potential issues during a batch production process
- Reduces contamination risks with better control of the environment
The Types
Environmental monitoring can be divided into two major categories:
- Viable contaminants testing
- Non-viable contaminants testing
Viable testing identifies the number of living microorganisms in the processing environment. The most common methods used are Contact Plate method, Swab method, Settling plate method, and Impaction method. These methods specifically test the surface and air contaminants.
Non-viable contaminants are non-living particles that may contaminate a sterile product. This includes dirt, dust particles, tiny metal shavings, and other sub-visible particles. Critical processing areas must be monitored for non-viable particulates to ensure sterility.
The Challenges
Environmental monitoring is complex. It includes event-driven data collection to study microbial genetics. This is a lengthy and time-consuming process. As sampling occurs in sterilized rooms, water, air, masks, gloves, etc. must be tested for contamination. While most organizations already have FDA-compliant processes in place, there can be inefficiencies. Repetitive data collection cycles can be expensive and may lead to data integrity issues. Human errors in EM can also threaten compliance.
The Digitalization Need
Manual EM systems may lead to discrepancies and manipulations. Labs can also face storage and traceability issues. Manual tasks take up a lot of lab analysts’ time and effort.
Digitalization automates the recording and analysis of environmental monitoring data. With an automated EM system, controlled monitoring of sterile environments in QC labs becomes easier and more accurate. It reduces manual effort, errors/deviations, and time. It also guarantees reduced review time, increased productivity, and enhanced quality.
The End-to-end Paperless Monitoring Application
CaliberEMpro is a digital EM system for QC labs. It is a flagship addition to the Caliber suite of quality products. The system has safety features and easy, secure automation. It allows quick access to authorized users from anywhere. CaliberEMpro makes monitoring microbial activity throughout the EM lifecycle easy.
The application ensures the organization’s adherence to regulatory standards. It efficiently automates EM activities with 21 CFR part 11 and GMP compliance. This robust tool for labs is designed to help drive better decisions, perform efficiently, and store data securely. CaliberEMpro is your laboratory’s best companion for digital transformation.
The Conclusion
Any deviation from the standard guidelines may affect the whole environment. It may also compromise the potency, integrity, sterility, and the quality of the final product. EM systems control contamination through rigorous monitoring of all relevant factors and prevent loss of control through early detection.
An integrated EM system such as the CaliberEMpro ensures a clean environment for the processing of sterile drug products. CaliberEMpro consists of 11 plug-and-play modules with instrument management as a standalone microservice. Its exclusive set of features monitors everything from planning and execution of sampling to incubation. It easily integrates with LIMS and other systems. The robust application simplifies monitoring and ensures compliance with good manufacturing practices (GMP) and 21 CFR part 11 guidelines.
Download the CaliberEMpro Brochure here!
