Tradeline asked 120 individuals representing 98 research organizations to prioritize their areas of focus for 2013 and to make open-ended comments regarding those priorities. The priorities identified in this survey will be the focus of Tradeline's upcoming conference: The 2013 International Conference on Biocontainment Facilities on March 18-19, 2013, in San Diego.
The respondents’ overall priorities are:
1. Pressure and airflow control
2. Maintenance/operations requirements and processes
3. People, teams, and competency
4. Facility design requirements, upgrading aging facilities for safety and regulatory compliance
5. Commissioning, re-commissioning, and revalidation
Pressure and Airflow Control
Without question, maintaining pressure control and airflow is one of the most critical issues for institutions, and new solutions and experience are needed to meet regulatory guidelines in the BMBL 5th edition. The the main concern is the definitive “will not” statement in the BMBL: “...under failure conditions airflow will not be reversed.” Some say it is impossible to avoid some airflow reversal under failure conditions, whether it is for 5 seconds or 30 seconds, but the language “will not” implies that no excursions are allowed at all. Some institutions confirmed that they have solved this problem by balancing unique engineering solutions with risk assessment. If some pressure reversal or airflow reversal is allowed, the duration, volume, or conditions acceptable through proper risk assessment need to be clarified. Maintaining HVAC equipment and systems to perform as designed, and benchmarks to evaluate reliability and ease of use and maintenance, are also in demand.
Representative statements regarding pressure and airflow control:
- Avoidance of reversal of airflow—how do we do that?
- Complying with the BMBL “no reversal of airflow” is our top priority.
- Maintaining pressure control during an outage is the most important criterion to meet, and the hardest.
- What are the ongoing developments with how labs are responding to BMBL 5th edition “no reversal of airflow?”
- Keeping overhead down while maintaining multiple, changing (and conflicting) regulatory requirements is our greatest challenge.
- Resolving single pass air/HEPA filtration/HVAC set-back parameters for cost reduction without compromising safety is very important for our operations.
- Emergency response planning and requirements for continued operations—redundancy, SOPs.
- Maintaining directional airflow and pressure gradient without reversal is our greatest challenge.
Maintenance/Operations Requirements and Processes
Maintenance/operations requirements and processes to lower operating costs are top priorities for biocontainment facility programs for 2013. Organizations are increasingly challenged by facility commissioning, and annual re-certification, re-validation, and preventative maintenance measures. New processes and procedures are needed for scheduling annual shutdown and startup of biocontainment programs that minimize both operational costs and disruption to ongoing research programs. New MEP solutions are required that are easy to repair and maintain, that ensure the safety of maintenance and research teams, and that reduce operating costs. Building Automation Systems and new MEP systems and equipment provide better environmental controls and a safer, more predictable working environment for researchers and maintenance workers, but these systems and equipment require more sophisticated skills and experience to maintain and operate than traditional maintenance staff is trained to handle. Staffing issues relating to recruiting, training, and retaining operating and maintenance personnel continue to be a challenge. Reduced operational budgets continue to force facility management leaders to do more with less money and fewer people.
Representative statements regarding maintenance/operations requirements and processes:
- What is the state of the art for operating efficiency in new construction or upgrades?
- Big thrust here: Trying to find ways to cut cost while not compromising safety and function.
- How do we minimize operational costs without incurring large capital costs?
- We are concerned that our maintenance staff will not be able to properly operate and maintain the lab.
- What is working at other institutions, and what has failed?
- Doing more with less is the buzz statement that may be an overarching theme for many.
- Safety, costs, ROI, and contribution to the bottom line reign supreme.
- What’s possible in terms of energy-use reduction and lower air change rates for biocontainment?
People, teams, and competency
People, teams, and competency in planning, building, and maintaining biocontainment facilities are critical to their safe, secure, and low-cost operation. Too often architects, designers, contractors, and maintenance staff without expertise in building and maintaining biocontainment facilities are the root of problematic facilities—leaky secondary barriers, pressurization, and improper choice of surface materials for building infrastructure, lab furniture, and scientific equipment—causing delays in startup and huge cost overruns to remedy operating issues. An understanding of project team development and requisite expertise for everyone involved, from risk assessment to validation and startup, must be defined. Clear understanding of regulatory guidelines and coordination among staff and project team members is critical to functional biocontainment facilities because there are many sometimes-conflicting compliance guidelines.
Representative statements regarding people, teams, and competency:
- Lowest bid is NOT the way to go with these types of facilities. An understanding of project team development and requisite expertise needs to be defined.
- We need to train people to perform O&M properly and deliver functional facilities. This has BIG ramifications for facility performance—energy and utility costs, equipment functionality, etc.
- BMBL guidelines and regulatory requirements are interpreted differently by key personnel involved in our projects and engineering staff. There needs to be clarification here, i.e removal of interpretation factors.
- We need clarity on the risk assessment-designing-commissioning-regulation-validation-revalidation cycle. These are not individual tasks—biocontainment requires a higher level of collaboration and feedback loops.
- We are understaffed and under-skilled with a reduced budget.
- We need to train our personnel better on sophisticated control systems and principles of biocontainment systems.
Facility design requirements, upgrading aging facilities for safety and regulatory compliance
Many biocontainment facilities have been operating for years under severe conditions (corrosive decontamination procedures and strained MEP systems and equipment) and are in desperate need of upgrades to restore fatigued facilities and equipment, and to comply with a new regulatory and safety requirements that they can no longer meet. For many institutions, budgets are severely constrained, and capital expenditure on upgrades is not an option, so new minimal-cost solutions are needed to keep facilities operational, compliant, safe, and secure.
Representative statements regarding facility design requirements, upgrading aging facilities for safety and regulatory compliance:
- Building equipment is getting older and less reliable. I know others have the same issue and same budget restraints. We can’t afford containment failure because of equipment failure.
- Aging BSL-3 labs requiring steadily increasing levels of maintenance and upkeep are becoming a real problem.
- It is very difficult to keep up with changing requirements, especially in older facilities.
- Updating deteriorating systems and outdated controls technology is our top priority.
- Managing, isolating, and/or integrating separate HVAC and BMS systems are important for us.
- We need a whole new set of preventative maintenance processes and procedures. Containment labs and related equipment have a short life span—corrosion, drive wear and tear, etc. We need to extend the life to save money.
- We need to retrofit some of our labs for BSL-3 capability without “bells and whistles.” Is this possible, and what are the requirements?
- How do we deal with space constraints for new systems to support added BSL and ABSL containment areas?
- Which construction materials are the best choices for the interiors of biocontainment labs?
- We are getting ready to build a new BSL-3 facility. What are the newest developments in MEP systems and pressure control for containment facilities?
Commissioning, recommissioning, and revalidation
Startup, recommissioning, and revalidation are becoming a top focus for operations and maintenance planning as more BSL facilities come online and plan for shutdown. Industry standards and best practices to schedule shutdowns and reduce associated costs top the list of needs. Checklists, processes, and real-world examples of institutions that are successfully performing the commissioning process from planning to initial operation to recommissioning and revalidation are highly sought after. There is a still a significant need for clarification of requirements and processes associated with commissioning, re-commissioning, and validation, and the industry would benefit from a clear definition of each. Upgrades and renovation initiatives to install new energy-efficient and regulatory-compliant systems and equipment are necessary as more facilities have logged significant run time; this can be coordinated during shut down. Solutions on how this can be coordinated and accomplished quickly—at low cost—are in high demand.
Representative statements regarding commissioning, recommissioning, and revalidation:
- Trying to plan a building-wide shut down, keeping scientists’ needs met, and re-verify all operating systems is our priority.
- There is too much confusion regarding commissioning, re-commissioning, and validation. A presentation on this will be very useful for future projects, and shutdowns/re-verification of systems.
- We need to define actual commissioning/re-commissioning requirements—process, scheduling, and budget.
- Any major renovation requires a level of validation before rooms are allowed back in service.
- It took us nine months to get our new BSL-3 facility commissioned and operational last year. Are there standardized procedures available for this that we can implement in upcoming projects?
- With a series of new BSL suites coming online, the commissioning and re-commissioning of functional labs is of interest.
