Compliance

Maximizing Operating Efficiency of High-Containment Labs

Select Agent Experiment Conducted in 30 Days, Thanks to Staffing and Management Model

Published 1-21-2015

Researchers at Duke University Medical Center’s Regional Biocontainment Lab (RBL) recently organized and launched a select-agent-based study in just 30 days from inception to conclusion, thanks to the organization’s highly efficient operational framework. Fast tracking of the study—which involved aerosol exposure of 38 immunized mice to Francisella tularensis, the causative agent of tularemia—was made possible through the facility’s strategic management and cross-trained staffing model.

Getting BSL-3 Labs to Pass Failure Scenario Requirements

Commissioning for No Reversal of Airflow and the Cost of Failure

Published 12-3-2014

Regulatory requirements for using directional airflow as the primary method of containment in BSL-3 labs is a simple concept, however the engineering and controls required for today’s facilities present an array of challenges when it comes to conducting “failure scenario” tests during commissioning and shutdown, and startup procedures during normal operations. Maintaining collaboration between the occupants, an experienced architect, and an objective third-party commissioning partner while designing or redesigning a BSL-3 lab can prevent costly delays and complications.

Addressing Biosafety Regulations with Risk Assessment and Verification Planning

Charting a Roadmap to Compliance and Cost Effectiveness

Published 11-5-2014

Using a verification planning process to meet current regulations—for directional airflow, atmospheric pressure reference, containment barriers, and other common compliance measures—with solutions based on risk analysis and standard operating procedures (SOPs), takes a project through planning and design to fully licensed and operational, and helps minimize spending on solutions to a level that is risk-appropriate.

Upgrading Facilities for No Reverse Airflow Compliance

Necessary Systems and Practical Solutions for Regulatory Requirements

Published 1-29-2014

Bringing biosafety laboratories into compliance with the BMBL 5th Edition’s “zero airflow reversal” clause requires assessing risk appropriately, analyzing the impact of a pressure envelope on the facility, installing appropriate ventilation and control systems, and implementing new control strategies for practical testing.

2014 Biocontainment Facilities Priorities

Industry Leaders Share Their Thoughts, Help Shape Upcoming Conference

Published 1-15-2014

The following is a compilation of responses to a survey that asked individuals responsible for planning, design, operations, and maintenance of high-containment facilities to rank their priorities for 2014 and make open-ended comments regarding those priorities. The issues identified in this survey will be the focus of Tradeline’s upcoming conference—The 2014 International Conference on Biocontainment Facilities—on April 10‐11 in Scottsdale, Arizona.

The respondents ranked their overall priorities as follows:

Measuring Reverse Airflow in Laboratory Failure Conditions

Yale Presents a Quantitative Measurement Using Fluorescent Beads

Published 9-18-2013

A study at Yale University suggests that quantitative performance analysis of laboratory airflow may show more conclusive results than traditional methods of measurement, and thus obviate the perceived need for costly retrofits and upgrades in order to comply with the CDC/NIH’s new prohibition against reversal of airflow under failure conditions found in Biosafety in Microbiological and Biomedical Laboratories 5th Edition (BMBL).

Proposed ANSI Standard on BSL-3 Ventilation Systems Open for Review

Document Provides Methodologies and Resources for BSL-3 and ABSL-3 Labs

Published 8-14-2013

The American National Standards Institute (ANSI) will be collecting comments through Sept. 10 on its new standard, Testing and Performance-Verification Methodologies for Ventilation Systems for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Facilities, also known as ANSI Standard Z9.14-2013. The 127-page document provides guidance for the inspection and testing of ventilation system components of new or existing BSL-3 and ABSL-3 laboratories, including research, pharmaceutical, and insectary facilities.

Best Practices for Successful Revalidation of BSL-3 Labs

Undergoing Process Annually Helps Preserve Science, Financial Investment

Published 8-7-2013

Annual revalidation of BSL-3 biocontainment facilities—which involves verifying that systems are operating to specifications—is important not only to maintain a safe working environment for scientific needs, but also to reduce utility and maintenance costs and protect the substantial financial investments such buildings represent. The time and expense of the revalidation process can be minimized with careful preplanning.