Atlantic Technical Systems (ATS) was formed in 1999 to provide service to the pharmaceutical industry. ATS launched a testing laboratory in 2010 due to the growing demand of the pharmaceutical industry and increased need for compliance services. In 2016, the testing laboratory was spun off as Atlantic Test Labs (ATL). Atlantic Test Labs has successfully achieved the International Organization of Standardization (ISO) 17025 accreditation by The International Accreditation Service (IAS), demonstrating that our company works to the highest degree of ethical, technical, and legal standards.
Our mission is to provide the technical services, products, and guidance that meet and exceed the requirements of the Food and Drug Administration and pharmaceutical industry. As a laboratory with longstanding regulated industry expertise, we are fully committed to providing our customers with results that will exceed the requirements of regulatory bodies. Our current laboratory facilities were designed from the ground up based on the Food and Drug Administration regulations and pharmaceutical industry standards. Our goal is to merge our decades of experience in pharmaceutical testing, commitment to compliance, and unparalleled customer care to service the medicinal cannabis industry in Maryland.
Our company is committed to delivering the highest quality results that our pharmaceutical 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 customer specific 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 only validated procedures. Everything is based upon sterility and contamination control. 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 manufacturer methods specific to their 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.
The International Accreditation Service (IAS) is a nonprofit, public-benefit corporation that has been providing accreditation services since 1975. IAS accredits a wide range of companies and organizations including governmental entities, commercial businesses, and professional associations. IAS accreditation programs are based on recognized national and international standards that ensure domestic and/or global acceptance of its accreditations.
As one of the leading accreditation bodies in the United States, IAS is a signatory to the four primary international organizations that form a unified system for evaluating and recognizing competent accreditation bodies worldwide. These organizations have agreed to cooperate with one another by adhering to a common set of accreditation criteria and to undergo periodic onsite evaluation to determine ongoing compliance with ISO/IEC Standard 17011. Being a “signatory” means that an accreditation body has been evaluated onsite at its offices, a sampling of the assessments of its accredited entities have been witnessed by peer experts, and that it has been found to comply with international requirements.
For more information, please visit iasonline.org/about-ias/.