Our Lab Environment
Our company is committed to delivering the high-quality results that our customers demand. Therefore, we engineered our laboratory facility to be secure and aseptic. The laboratory facility is under controlled access and continuously video-monitored. Our microbiology and chemistry laboratories were designed to meet requirements set forth by ISO 14644 for Class 7 cleanrooms. A dedicated anteroom allows staff sufficient space for personal gowning and product selection in order to minimize the generation and transportation of particulate. Personnel who utilize the anteroom are able to change into clean room garments and wipe down equipment to minimize contamination risks.
While contaminants are naturally present in all facilities, large particles settle and smaller particles remain airborne. Additionally, normal activity causes settled particles to become airborne. Equipped with this knowledge, we designed our laboratories to be equipped with state-of-the-art HEPA filters that scrub the air entering our laboratories. Each HEPA filter is 99.99 percent efficient at blocking particles 0.3um and larger. Critical work is performed directly within HEPA filtered equipment, which provides clean filtered air that washes particles away from the work surface.
Atlantic Test Labs management philosophy is deeply rooted in partnering with our clients to provide fully auditable test results in accordance with regulatory requirements. Since 2010, when we opened the only microbiology laboratory in Maryland to specifically target the needs of the pharmaceutical industry, we have consistently delivered high quality results tailored to our clients’ needs. Strict quality control is insisted upon to guarantee that every job is done right every time. The health and well-being of the patient depends on it.
As an ISO 9001:2015 registered company, our quality management system provides the framework which allows us to provide consistent client interactions and continually improve our methods. Our organization operates with written procedures which govern all aspects of the company; from document control and management responsibility to individual test methods and equipment operating instructions. ISO 17025:2005 adds yet another layer of quality control to our laboratory testing procedures with strict rules governing methods, data analysis, and reporting processes.
Our laboratory protocols have been established using validated procedures. We maintain fully traceable documentation for the entire process of sample testing. Our methods are taken directly from the United States Pharmacopoeia, American Herbal Pharmacopoeia or methods specific to a manufacturer’s equipment, which are then internally validated.
Our equipment has been selected to support our guiding principles of reliability, reproducibility, and repeatability. Our entire workflow process is designed to eliminate sources of error, both environmental and human. By using only validated (IQ/OQ/PQ) equipment and methods and conducting our testing in a particulate controlled environment, Atlantic Test Labs can guarantee precision in your results.