The control of microbiological contamination in drugs and biologics is essential to patient safety. With more than 25 years of experience developing cleanroom contamination control and environmental monitoring programs in the pharmaceutical, manufacturing and pharmacy industry for controlled environments, Element’s complete suite of cleanroom testing services are designed to ensure the control of microbiological contaminants in critical environments as well as the quality of small and large molecule drugs.
To protect the safety of patients, end-users, and equipment operators, in addition to preventing cross-contamination and ensuring the cleanliness of manufacturing and packaging equipment, drug manufacturers and compounding pharmacies must demonstrate routine facility cleaning procedures limit potential contamination according to documented specifications. The evaluation of environmental controls that have been established in controlled environments, including cleanrooms and sterile compounding areas, is essential to minimizing and controlling particulates and microbial contaminants.
Comprehensive environmental monitoring (EM) programs include not only a microbiological environmental program, but also assess personnel-gowning performance and aseptic behavior, as well as the efficacy of cleaning and disinfection procedures. Element offers a comprehensive suite of controlled environment monitoring services to verify validated cleaning procedures have been implemented effectively. Our teams of regulatory and scientific experts have decades of experience designing robust programs that meet microbiological environmental monitoring guidelines for leading organizations, ranging from large pharmaceutical manufacturing companies to compounding pharmacies and hospitals. Our expertise extends to the development, implementation and monitoring of risk-based environmental monitoring programs. Element’s consultative experts also offer wrap-around services, including environmental monitoring mapping, filter integrity testing, cleanroom training, training of staff in proper aseptic practices, and a broad range of cleanroom consulting services.
Cleanroom certification and controlled environment monitoring services
- Surface, viable air, total particulate air (non-viable) sampling
- Compressed gas contaminant testing
- Compressed air line sampling
- Passive/setting plates
- Autoclave validations to FFDCA Sections 503A or 503B for compounding pharmacies
- Primary Engineering Control (PEC) (laminar flow hoods, isolators, and Class I, II, III biological safety cabinets)
- Growth promoted media
- Calibrated equipment
- Incubation and enumeration
- Microbial identification
- Electronic reporting
- Customized environmental monitoring SOP generation
Cleanroom validation and facility validation support
- Environmental monitoring performance qualification (EMPQ) and environmental monitoring operational qualification (EMOQ/EMPQ/OQ/PQ)
- Disinfectant and cleaning studies
- Water system qualifications
- Risk assessment
- Summary report
Environmental monitoring excursion investigations
- Root cause analysis
- Corrective action/preventative action (CAPA)
- Training (on-site and/or virtual)
- Investigational sampling
- Excursion response SOP
Aseptic technique and gowning services
- On-site gown training and qualification
- Cleanroom behavior training
- Aseptic technique qualification
Ensure compliance to microbiological environmental monitoring guidelines
Element’s extensive experience meeting both state and federal regulatory expectations, along with a quality-centric, “first time right” mentality, ensures environmental monitoring programs are designed to yield both cost savings and high-quality results. Our EM technicians are thoroughly trained on aseptic technique, gowning, sampling, and the science of microbiology within the cleanroom environment. This unparalleled blend of experience, staff development and training, and extensive regulatory, industry, and scientific knowledge allow Element to offer industry-leading cleanroom validation solutions, including controlled environment monitoring, cleanroom testing services, and environmental monitoring of sterile compounding areas.
Environmental Monitoring programs allow manufacturers and compounders to measure and monitor cleanliness and contamination levels within their facility. Element provides comprehensive EM services, as well as education and training in proper aseptic practices for your staff. We will partner with you to validate your cleaning and disinfection processes, as well as aseptic technique, to help you produce the safest possible product.
Environmental monitoring of sterile compounding areas
Compounding pharmacies must comply with the cleaning and sanitizing guidelines detailed within USP <797> for compounded sterile preparations (CSPs). Furthermore, when handling hazardous drugs in healthcare settings, the procedures and guidelines detailed within USP <800> must be followed. Environmental monitoring of sterile compounding areas is critical to demonstrate compliance to this regulatory guidance. Specifically, daily cleaning and sanitizing is required for counters and easily cleanable work surfaces and floors, and walls, ceilings, and storage shelving must be cleaned and sanitized monthly. Furthermore, ISO Class 5 PEC sites must be minimally cleaned at the beginning of each shift, before each batch, every 30 minutes when compounding, after spills, and when contamination is known or suspected.
Environmental monitoring programs detect contamination in compounding pharmacies and are a critical tool in identifying conditions within controlled environments that lead to excessive microbial levels, which can include ineffectual cleaning, sanitation, aseptic technique, and insufficient hand hygiene and gowning. Element’s consultative teams of experts offer USP <797> testing, as well as comprehensive monitoring, qualification, training programs to ensure cleanroom and manufacturing environments are compliant with regulatory standards, including FDA, USP and ISO 13485 and ISO 14698 guidelines.
The Element advantage
Comply with regulatory requirements while simultaneously refining manufacturing processes and keeping costs low with Element’s comprehensive environmental monitoring and cleanroom certification and testing services, customized to meet the specific needs of your facility, manufacturing processes, and finished product.
To learn about our customized approach to controlling microbial contaminants in biopharmaceutical manufacturing facilities, compounding pharmacies, hospitals, and more, or to speak with one of our experts, contact us today.
Sterile Compounding Services
Element provides USP <797>, USP <800> and cGMP FDA compliance expertise and testing solutions for home infusion, pharmacies, hospital pharmacies and human drug outsourcing compounding facilities.800>797>
Media-Fill Test Kits
Our media-fill test kit program provides aseptic compounding proficiency test kits that validate confidence in your aseptic procedures.
On-demand Webinar: EM and Contamination Control in the Compounding Pharmacy
Watch a free webinar on USP <797> controlled environments and environmental monitoring.
Element offers Disinfection Qualification studies for the pharmaceutical industry and Disinfectant Efficacy studies for the antimicrobial industry.