Services: Cleanrooms & Controlled Environments
QA Consulting works with each client and device to develop the regulatory and technical basis for test omission, test requirements, protocols, lab selection and reports. Testing ranges from screening of new materials to pre-market safety, product release and periodic audits.
Cleanrooms and Controlled Environments are typically used for manufacturing sterile medical devices. In accordance with international standards, these rooms require validation, operational procedures, routine testing, and robust systems for handling out-of-specification results from a routine monitoring regiment.
Our consultants have extensive experience with the design, validation, and operation of Cleanrooms and Controlled Environments and we can assist with the following:
- Gowning
- Cleaning
- Transfer of materials
- Maintenance
- Environmental monitoring program
- Investigating out of specification conditions
- Training
- Routine Monitoring
What is a Cleanroom?
A Cleanroom is a room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room, and in which other relevant parameters (e.g. temperature, humidity, and pressure) are controlled as necessary
What is a Controlled Environment?
A Controlled Enviornement is a defined zone in which sources of contamination are controlled by specified means.
What Standards are associated with Cleanroom and Controlled Environments?