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Controlled Environment Services
STERIS provides high-quality contamination control services for cleanrooms, facilities, and equipment in the pharmaceutical, biotechnology, research, and laboratory industries.
With a goal of creating a comprehensive portfolio of certification and decontamination services across various industries, STERIS established a subsidiary, Controlled Environment Certification Services, Inc., through the following acquisitions:
- Agape Instruments Services, Inc.
- Southeastern Certification, Inc.
- Micro-Clean Certification Services, Inc.
- SixLog Corporation
In order to ensure optimum performance and maintain compliance to regulations, put your trust in our accomplished team.
- ISO 9001 certified with more than 40 years of technical industry experience and consultation
- Certified and accredited field-based experts using the latest technology and procedures
- Compliant with federal and state agency industry regulations
The Controlled Environment service portfolio includes certification for HEPA-filtered devices and cleanrooms, plus biodecontamination and environmental monitoring for your most critical applications and equipment. Our cleanroom equipment testing and prompt results meet your needs with little disruption to normal workflow.
Get the most precise and efficient service possible with the industry-leading technology, training, and experience we bring to every project.
Equipment and Cleanroom Certification
- Cleanroom Certification
- Biological Safety Cabinet and Equipment Certification
Decontamination Service Offerings
- Our Process
- Our Products
- Facility and Equipment Decontamination
- Routine and Emergency Remediation
Adhere to the most demanding industry standards by demonstrating control of your critical areas with our environmental monitoring services.
STERIS experts help create quality assurance programs and perform testing to provide results needed for cleanroom monitoring. We’ll help you conform to industry standards, including:
- ISO 14644-1
- USP 797
- USP 800
- FDA Guidelines
Viable and Non-Viable Testing
To accurately assess your potential for contamination, our certified technicians collect samples of the air and surfaces in your critical areas. By utilizing our ISO 17025 accredited microbiology laboratory for testing and analysis, you will receive rapid results to ensure compliance.
Quality Assurance Programs
Our team supports the development and documentation of your quality assurance program for demonstrating compliance and environmental control of critical environments and equipment.
Additional Testing and Services
A safe and repeatable process is important for the quality and commercialization of your products. We work with you to understand your equipment and system processes to ensure your specific documentation requirements are met with current Good Manufacturing Practices (cGMP) and Good Engineering Practices (GEP). STERIS validation services are customized to help you comply with FDA requirements for:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Guarantee accuracy by keeping all your instruments and equipment precisely calibrated. Our in-house ISO 17025 accredited lab ensures you’ll receive your certificate of calibration and quality-reviewed reports quickly. STERIS calibration services comply with ANSI Z-540 requirements, and all instrumentation used is traceable to NIST standards. Current accreditation includes temperature, humidity, particle counters, pressure gauges, aerosol photometers, and thermal anemometers. Calibration capabilities include instruments and equipment from a wide range of manufacturers.
Compressed Air and Gas Testing
Testing the quality of compressed gas utility systems, such as compressed air, nitrogen, breathing air, and other gases is essential for ensuring product quality and meeting regulations. We provide compressed air line testing and compressed gas line testing and analysis per ISO 8573-1.
- Non-Viable Particle Count
- Viable Organism Testing
- Canister Collection and Testing
- Oil Testing
- Dew Point/Water Testing
Repairs & HEPA Air Filter Replacement Services
STERIS offers a wide range of HEPA filter and containment device repair services. Regularly working with leading equipment manufacturers enables our trained technicians to perform prompt diagnostics, troubleshooting, and repair. We maintain a stock of commonly used parts to ensure availability in critical situations. We can help you keep your equipment operational with minimal disruption or downtime.