Workers who handle infectious agents / materials and recombinant DNA materials are at risk for infections when handling these materials, when introducing these materials into research animals, or when moving from lab scale to production scale. EH&E’s biosafety and microbiology experts are experienced in academic and biotech laboratory and large-scale production facilities. We are experts in developing biosafety programs that minimize the risks of exposures and facilitate compliance with the guidelines for biosafety from the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH).
EH&E can support your biosafety program with the following services:
- Perform a gap analysis of the biosafety program to identify compliance gaps, ways to increase efficiency, and best practices.
- Provide guidance on the development and start-up of an Institutional Biosafety Committee (IBC), and provide ongoing support and facilitation as needed.
- Participate in the activities of the IBC, including review of recombinant DNA and biological agent protocols.
- Conduct a biosafety risk assessment of research with biological agents and recombinant DNA to identify potential hazards and required engineering controls, personal protective equipment (PPE), and training.
- Assist with efforts to obtain required permits and registrations for recombinant DNA, infectious agents and “Select Agents”.
- Conduct biosafety and laboratory safety inspections in laboratories and production facilities.
- Prepare and update site specific documents, such as biosafety manuals, exposure control plans, standard operating procedures and fact sheets.
- Serve as a liaison and technical representative for interactions with local, state and federal regulatory agencies.
- Customize our Web-based Research Protocol Management application to meet your unique needs; which has proven to streamline and improve management of the IBC protocol review process.
- Review research applications and new products; our staff can provide fast and complete reviews based on our extensive experience. Our review process can include a web-based collaboration system in order to fully engage onsite biosafety / EH&S staff, researchers, and manufacturing staff.
- Provide advice on the design of laboratories and manufacturing suites.
- Provide environmental health and safety support and commissioning services for biosafety level 3 (BL3) facilities.
For more information, email us at firstname.lastname@example.org or call 1-800-825-5343.