Infinity Laboratories Products & Solutions
Cleanroom Certification and Testing Services
A cleanroom is a specially constructed room designed to use HEPA filtered air and specific airflow design parameters to reduce contamination and control airborne particulates and environmental conditions in critical areas. Cleanrooms should be certified routinely to ensure compliance with individual client, industry, and other regulatory requirements. Infinity Laboratories can provide you with the appropriate level of service required to ensure your manufacturing environment complies with FDA, USP and ISO 13485 and ISO 14698 requirements.
Infinity Laboratories provides onsite Cleanroom Certifications, Environmental Monitoring (EM), and Cleanroom validation services to ensure that your cleanrooms and facilities are compliant with the regulations as defined by ISO 14698.
A validation establishes documented evidence that a process or system, when operated within established parameters can perform effectively and reproducibly to produce a product meeting its predetermined specifications and quality attributes. Whether you just completed a new cleanroom or redesigned an existing room, Infinity Laboratories can assist you with all your qualification and validation needs.
Cleanrooms and controlled environments are utilized to control the levels of non-viable and viable particulates that medical devices and pharmaceutical products are exposed to during the manufacturing process. The objective of an environmental monitoring program is to estimate the microbial and particulate content of room air and surfaces. An effective environmental monitoring program can alert you when conditions contributing to excessive microbial levels arise due to ineffective cleaning, sanitation, or other personnel/equipment issues.
Modifications to Cleanrooms/Controlled Environments should be evaluated to ensure the existing validation is still applicable. Addition of major components, expansion of the room and addition of more personnel and operations in the room can all affect the performance of the room. At the very least Alert and Action levels should be re-evaluated to ensure realistic cleanliness standards are kept within the room and sterilization validations do not become compromised.
We continuously work to enhance and protect patient lives through the critical testing services that we provide. We believe we can make a difference in the lives of patients worldwide. Our goal is to go Beyond Testing and become a partner in the success of our customers.
