Controlled Environment Room
A controlled environment room (CER) is a facility that has controlled parameters that meet industry standards. These parameters include, but are not limited to, contents of the air, temperature, and pressure. These environments are used for a variety of purposes in the NedTech industry, including packaging, quality control testing, manufacturing, and more.
When you need quality management done right, Cannon Quality Group is your go-to team. Clients trust us to deliver on-time, on-budget projects in the following areas:
- Controlled environment room and compressed dry air qualification, validation, and documentation
- Quality system procedures for controlled environment rooms
- Ongoing controlled environment room and compressed dry air services
Contact Cannon Quality Group to learn more about our controlled environment room in the San Francisco area as well as our quality management services.
Certified to ISO 14644-1:2015
Our controlled environment room is certified to ISO 14644-1. This international standard establishes a restriction on the amount of particulate matter that can be in the air of the controlled environment. Managing the level of particulate matter in the air can be challenging in everyday situations, which is part of what makes a certified cleanroom or controlled environment such a commodity. Our controlled environment room has a compressed dry air system that helps to regulate the environment, making it an ideal environment for testing, packaging, and other work with medical devices.
CER Qualification & Features
When you choose Cannon Quality Group, you choose the best solution for your CER needs in the Bay Area. Our controlled environment room meets all standards for medical devices as outlined in ISO 14644-1, and we can aide in the process of your project. Cannon Quality Group can help:
- Define the CER requirements for your project
- Create and execute a plan for use of the CER
- Establish an ongoing quality standard monitoring plan
Our shared-space facility has all the features you need to work successfully, including Wi-Fi, four lab benches, a fume hood, microscopes, and more.
Learn more about our controlled environment room and other shared spaces available from Cannon Quality Group today by contacting us online today.
CER Quality Standards
Cannon Quality Group has multiple procedures in place to support the standards of a quality CER. These include regular environmental monitoring, gowning, and cleaning of the CER. As part of our cleanroom, we also have a gowning room that is certified to ISO Class 8.