Environmental Monitoring
ServicesEnvironmental MonitoringWhile cleanroom validations and certifications are snapshots in time, environmental monitoring (EM) studies work to understand potential sources of contamination on an ongoing basis. Typically, environmental monitoring testing procedures are conducted daily for critical zones and weekly for less critical areas, trending microbial and particulate content over time. Infinity Laboratories supports pharmaceutical and medical device manufacturers, ensuring compliance with all FDA, USP, ISO 13485, and ISO 14698 requirements.
While cleanroom validations and certifications are snapshots in time, environmental monitoring (EM) studies work to understand potential sources of contamination on an ongoing basis. Typically, environmental monitoring testing procedures are conducted daily for critical zones and weekly for less critical areas, trending microbial and particulate content over time. Infinity Laboratories supports pharmaceutical and medical device manufacturers, ensuring compliance with all FDA, USP, ISO 13485, and ISO 14698 requirements.
Environmental Monitoring Program Design
Your EM program must demonstrate control over viable and non-viable particles found in critical areas of your operation. However, standards and guidances are not prescriptive and do not instruct a pharmaceutical or medical device manufacturer on how to achieve this control.
With two decades of testing experience, Infinity can help guide your EM program with a risk-based approach that demonstrates understanding of and control over the operation. A robust EM program will include monitoring the air, personnel, and surface areas within the cleanroom environment to understand the presence and levels of viable and non-viable particles.
A comprehensive EM program will include surveillance of:
Cleanroom Personnel
The primary origin of contamination within your cleanroom facility is people. Comprehensive personal protective equipment (PPE) donning and doffing procedures that align with the cleanroom grade must be established.
Cleanroom Air
HVAC contamination control systems continuously control air. Pressure, temperature, and humidity are generally all monitored. However, air monitoring for viable and non-viable particle counts can vary based on the cleanroom’s grade and the nature of the operations conducted in the cleanroom. An environmental monitoring program will also include maintenance and calibration of air samplers to ensure data accuracy.
Cleanroom Surfaces
Cleanroom surfaces, including floors, walls, and equipment, must be cleaned at defined intervals using established procedures and then monitored. Typically, viable particle counts will be monitored by using contact plates.
Environmental Monitoring Testing Services
Infinity supports clients’ EM programs, including aseptic manufacturing facilities, by sampling on-site or receiving plates containing EM viable samples to incubate, count, and report. We offer full-service EM testing solutions — personnel, surface, air, water, and other utilities monitoring — allowing our pharmaceutical and medical device customers to achieve regulatory compliance and ensure product and patient safety.
Air Monitoring
Air Monitoring
Environmental Monitoring Testing
Utilizing active and passive air sampling techniques and counting nonviable particles provides critical insights into the cleanliness and control of the environment.
Surface Monitoring
Surface Monitoring
Environmental Monitoring Testing
Surface environmental monitoring using swab sampling techniques, contact plates, surface contamination evaluation, and trend analysis to determine potential surface contamination sources within key production areas. Over time, surface monitoring data provides supporting evidence for the effectiveness of cleaning and disinfecting protocols.
Personnel Monitoring
Personnel Monitoring
Environmental Monitoring Testing
Particularly within aseptic environments, facility workers are one of the most significant sources of contamination risk. Personnel monitoring is critical during the donning and doffing qualification process. Additionally, contact plate sampling of personnel is typically conducted after suspected contamination events.
Water Monitoring
Water Monitoring
Environmental Monitoring Testing
Water system validation and thorough water environmental monitoring strategies are necessary to maintain water compliant with all regulations and standards. Given its role as a critical raw material and cleaning and process utility, understanding water quality, specifically its microbial bioburden and endotoxin levels is essential.
Utility Monitoring
Utility Monitoring
Environmental Monitoring Testing
Microbial monitoring of utilities such as compressed air and steam for sterilization systems must be included within a pharmaceutical or medical device facility’s EM program.