Compliance

Bigger is not always better when it comes to generators and their distribution systems. Oversizing a piece of equipment has a domino effect on the infrastructure needed to support it and the square footage it occupies, as well as capital, operating, and maintenance costs, all of which cut into funding that could go toward research. Determining which generator is best for a research facility requires an understanding of many factors, including the current and projected loads, site parameters, risk assessment, flexibility requirements, and operating concerns.

Complex technology, expanding program, and increasingly specialized and segmented roles and responsibilities often create a disconnect in the process of designing and building sophisticated facilities. The result can be a research or diagnostic lab or high-containment animal building that becomes a burden to the owner, whether because it hasn’t been right-sized, is not energy efficient, or operates with sub-par reliability. The solution is to assign someone the task of aligning design decisions with the building’s ultimate scientific mission.

The Pirbright Institute’s Plowright Building transforms the standard box-in-a-box bunker-like containment facility into an interactive environment filled with natural light, expansive views through full-height windows, and extensive opportunities for collaboration. Offices, a cafeteria, and a three-story glass atrium all exist within the containment barrier, reducing the number of times researchers need to shower and gown in and out each day.

In the ever-evolving quest for sustainability, engineers and their clients may find the 2013 updates to ASHRAE 90.1, the energy code that predominantly guides the design of buildings, useful in benchmarking energy efficiency for new or remodeled laboratories and vivaria. Regular review of the code ensures compliance for new projects and offers an opportunity to refine best practices for building envelopes, mechanical systems, lighting, and noise mitigation, say Adam Golubski and Philip Walter of The Clark Enersen Partners.

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.

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.

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.

Bringing biosafety laboratories into compliance with the BMBL 5^th 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.

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:

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 5^th Edition (BMBL).

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.

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.