We are confident that the addition of this room will help our organization safely and confidently handle and fill regulated products such as dental, medical, OTC, veterinary, pharmaceutical and cosmetics.
Waukegan, IL (PRWEB) April 15, 2014
American Empire Manufacturing (AEM), a leading provider of contract unit dose packaging, labeling and filling services, announced today it has installed, qualified and certified an ISO 8/Class 100K Clean Room within its 20,000 square foot manufacturing facility to better meet the increased demand for their services amongst companies operating within the healthcare, dental, veterinary and cosmetic industries.
Features of the new 400 square foot space include a 6’ X 10’ gowning room, a laminar flow design that inherently forces any particulate or airborne contaminants downward and out of the room and four 2’ X 4’ HEPA filtration systems that are programmed to filter the air introduced into the room and regulate the number of air turns per hour to ensure compliance to ISO 8/Class 100K requirements.
According to the firms' Chief Operations Officer, Joseph Trznadel, one of two automated filling machines have already been installed and qualified within the room. The machine is outfitted with an integrated tube and swab feeder, along with pharmaceutical grade, micrometer fed filling pumps that are spec’d out specifically based on the fill volume, viscosity and corrosiveness of the solution. All employees that work and operate equipment within this room have been trained and adhere to both company-mandated and cGMP/cGDP procedures.
Mr. Trznadel added, "While purchasing and installing a clean room was always part of our long-term strategic plan, expeditious organizational growth, combined with our strong desire to add key capabilities that aligned with the current needs of our customers, served as the catalysts for making this addition within the first few months of 2014. We are confident that this room will help our organization safely and confidently handle and fill regulated products such as dental, medical, OTC, veterinary, pharmaceutical and cosmetics."
Trznadel may also consider adding a second clean room of equal size to further enhance AEM’s filling capabilities and position the organization for future growth.
About American Empire Manufacturing:
Headquartered in Waukegan, Illinois, American Empire Manufacturing is a leading provider of unit dose contract packaging and liquid filling services. Its patented Pro Swab and Snap Tip Tube technologies are ideal for companies operating within regulated industries such as healthcare, veterinary, dental and cosmetics due to their easy-open design, no-mess, one-time use application and accurate administration of topical and oral medications.
For more information about American Empire Manufacturing and its services, visit their corporate website or call (800) 664-8990 to speak with one of their knowledgeable and friendly account representatives.