History of Germfree:
Germfree Laboratories, Inc. (Germfree) has been incorporated in the State of Florida since 1962. Since incorporation, Germfree has been manufacturing Class III Biological Safety Cabinets. In 1975, Germfree expanded the product line to include Class II Biological Safety Cabinets. Additionally, Germfree’s current product line includes mobile and modular laboratories customized for the global market, integrating our time tested containment equipment into these laboratories. Germfree was one of the first manufacturers to have Class II Cabinets listed under NSF (National Sanitation Foundation www.nsf.org) Standard #49 and still maintains the accreditation. Germfree equipment has even gone into space.
Laboratory Containment Division
Germfree has delivered over 300 Class III Biological Safety Cabinets (Gloveboxes) to meet the high containment needs of U.S. Federal and State Agencies. We have recently delivered, installed and participated in the commissioning of stationary and mobile Class III Gloveboxes for BSL-3 and BSL-4 laboratories located at U.S. Army Bases in Edgewood, Maryland; Dugway, Utah and Frederick, Maryland. The “Self-Contained Class III Animal Transport System” was designed with and built for the Aerobiology and Toxicology group at US Medical Research Institute of Infectious Diseases (USAMRIID). The system has become the new benchmark in flexible containment strategies because it combines leading edge ingress/egress technology (the Rapid Transfer Port) with unsurpassed ergonomic features. These Rapid Transfer Ports and the Transportable Glovebox are integral parts included in our mobile and modular laboratories.
Additionally, Germfree is the prime supplier of Portable and Mobile Class III Glovebox and Filtration systems that meet the military specifications for ruggedization and transportation with several branches of the U.S. Army, including: Technical Escort, JSIPP, Chemical Weapons Treaty Verification Laboratory and the National Guard. Germfree has an excellent working arrangement with the U.S. Army, having established two Cooperative Research and Development Agreements (CRADA) and two Patent Licensing Agreements (PLA). Germfree is currently the only supplier of Ruggedized Primary Containment for the Mobile Laboratory, including: Class III BSCs, Class II BSCs, and Class I Fume Hoods. Our experience with developing rugged transportable equipment has been the cornerstone of our development of mobile and modular laboratories.
Germfree has demonstrated national and international expertise in developing mobile, modular and container laboratories to meet user specific requirements. The project team at Germfree includes design and mechanical engineers, industrial engineers and hygienists, registered biosafety officers and end users. These experts, together with the construction team and principal investigators, work cooperatively on every step of the design, manufacturing and installation process to ensure that the safest, most comfortable and useful work area is ultimately achieved.
Germfree is a major sponsor of professional associations, such as the American Biological Safety Association, the Asia-Pacific Biosafety Association, and the American Glovebox Society. These organizations promote the development of better equipment and practices by sharing information and experience in open forums, lectures and courses. Germfree has also participated in many industry forums and workshops to further the advancement of laboratory safety. We recently participated in the International Biorisk Standard Development Initiative, CEN Workshop 31, developing the Laboratory Biorisk Management Standard for the European Union.
Pharmacy Division
Germfree Laboratories Inc. has manufactured Class II Biological Safety Cabinets since the mid 1970's. Company president, Dr. Jerome Landy, realized the applicability of the technology to the healthcare field and added the "BioFlow Chamber" as a standard product to Germfree's growing Biological Safety equipment offerings.
Germfree equipment has been purchased by more than 5000 institutions and companies in the US and 60 other countries worldwide. Our equipment has even gone into space. Our stainless steel Biological Safety Cabinets are located in more Hospital Pharmacies, Home Healthcare Agencies, Educational Institutions and Oncology offices than those of any other hood manufacturer.
Germfree Laboratories' equipment is known for its durability and longevity. We have a number of customers that, with little maintenance, have had their equipment running for more than 35 years. We are the sole supplier of Vertical Laminar Flow Workstations to Central Admixture Pharmacy Services (CAPS) locations across the country and have records indicating perpetual operation of our equipment for over 10 years without failure. Since the establishment of CAPS, Germfree Laboratories has provided them with more than 200 units and continues to supply large amounts of equipment for each of their new facility launches.
Approximately 10 years ago Germfree Laboratories Inc. was approached by pharmacists in the New Jersey area to build a fully closed biological safety cabinet for compounding sterile preparations. Retail pharmacies had begun to perform home health care work and were looking for an alternative strategy to fulfill the State Board of Pharmacy's requirement that the work be done inside a cleanroom.
Gloveboxes and Isolators had been used in Europe for compounding sterile preparations outside of a cleanroom for many years previous and the technology was further proven by its use in Pharmaceutical manufacturing to enclose entire aseptic fill lines. Healix also came to Germfree looking for equipment that would allow them to complete their compounding of parenteral solutions while awaiting the completion of cleanroom construction.
After much feedback and advice from the interested pharmacists, the first generation LFGI was built and purchased in early 2000. Since that time we have made minor modifications to increase user productivity and comfort as well as transportability.
When the new USP <797> regulations were announced, Germfree Laboratories Inc. immediately realized that our current LFGI product description of the barrier isolator mentioned in the document. In fact, it surpassed the regulations. Since the regulations have come into effect it has been our goal to educate our customer base on their options. We have teamed with two large cleanroom manufacturers (Angstrom Technologies in the East and Modular Cleanrooms in the West) to a representative network that can provide both cleanroom and barrier isolator compliant solutions.
Germfree Laboratories' goal has always been to provide a full range of quality safety equipment to meet the pharmacists' needs. Through continued dialogue with practicing pharmacists we will be developing a number of new design elements to further increase productivity and provide an even more ergonomically correct workspace.
