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. In this process, 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.
What is Environmental Monitoring in the Pharmaceutical Industry?
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.
Purpose
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.
What does it involve?
The EM process involves various key aspects of the drug manufacturing process to ensure a clean and sterile environment. However, with a major focus on air, surfaces, people, and water, gas, media, culture, and equipment also must be monitored. Each EM system is unique to the process, plant, and product.
- Air Monitoring: Air monitoring involves measuring and analyzing airborne particles and microorganisms in controlled environments. It ensures that sterile manufacturing areas remain free from contamination.
- Water Monitoring: Water monitoring refers to testing the quality of water used in drug manufacturing processes. It ensures water meets regulatory standards for microbial, chemical, and particulate purity.
- Gas Monitoring: Gas Monitoring includes measurement and control of gases used or present in the drug manufacturing environment. It ensures that gases supplied to cleanrooms, production lines, or directly into drug formulations meet strict purity and sterility standards.
- Equipment Assessment: It involves tracking and assessing the performance, cleanliness, and compliance of instruments used for the drug manufacturing process in quality control labs. Documented equipment monitoring ensures that all equipment operates within validated parameters.
Benefits of Digital Environmental Monitoring
A robust EM system notifies of any breakdown in the control measures. A clear policy on the level of microorganisms 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
Different monitoring 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 the Contact Plate method, the Swab method, the Settling plate method, and the 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.
Challenges with Environmental Monitoring
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.
Need for an automated EM system
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.
Introducing CaliberEMpro: The End-to-End Paperless Monitoring System
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 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!
