Biosafety & Biosecurity Services for International Clients

Around the world, public health and clinical diagnostic labs are critical for disease detection and control. Local research laboratories are essential for the development of new vaccines and diagnostic technologies to protect public health.

As countries try to improve public health the number of containment labs globally has increased by at least five-fold since 2004.

Perhaps you manage one of these local labs. If so, you may be familiar with some of these problematic statistics:

  • 30 of 56 African countries have no biosafety regulatory framework or guidelines. Simply working in or near a laboratory in these countries is an immediate hazard to your health. On those rare occasions when safety procedures are implemented, they’re implemented in a disjointed, inconsistent manner often lacking state of the art technologies.
  • 92% of Asian labs do not have biological safety cabinets or a biological waste management program. In China, this resulted in the re-use of hypodermic needles that spread chronic and fatal infectious disease to hundreds of thousands of young children. As a result, by 1991, 60% of the Chinese population was infected with Hepatitis B – a chronic disease leading to China’s #1 cause of death: liver cancer!
  • SARS has escaped 6 separate times from labs in Singapore, Taiwan and Beijing, China. FOUR distinct biorisk events originated from the same laboratory! These events prompted immediate World Health Organization involvement and strained relations between multiple Super Power nations. The cause? Poor work practices and improper waste management.
  • While a strain of H1N1 (influenza A) was being used to create a vaccine for swine flu in one country, it suddenly appeared in two neighboring countries. Laboratory scientists became infected and political tensions arose between nations. Poor work practices, a lack of biosafety and biosecurity protocols and ineffective training caused this to happen. Are you following best practices for handling of infectious materials?

Improper laboratory design, insufficient safety equipment and an absence of training significantly increase the risk of this type of work. The mix poses its own unique threat to local and world public health as well as national security.

You’re here because you’re aware of these risks. So, what can you do to minimize these risks to your workers, your organization and your community?

Inspirion has a long history of working with internationally funded programs to improve biosafety and biosecurity in laboratories around the world.

We’ve supported these laboratories with technical expertise, guidance and training. We’ve helped countries revise legislation and regulatory frameworks to account for improvements in technology, laboratory practices and design principles.

We’ve helped over 30 countries with:

Development of Regulatory Frameworks and Best Practices

Countries lacking a regulatory framework for biorisk management and countries that inconsistently implement biorisk management guidelines developed by other nations have scientists who become infected by their work materials and they have citizens who catch infectious diseases from medical waste. In these countries, the general population faces major health risks due to improper sample handling and poor waste management practices. Even with vaccination programs, it’s essentially impossible to bring infectious disease rates under control in these locations.

As the world’s biorisk management authority, Inspirion staff members have led or participated in national regulatory framework development efforts in multiple countries. We have contributed to multiple revisions of biorisk management manuals including Biosafety in Microbiological and Biomedical Laboratories not to mention multiple CEN Workshop Agreements (CWA 15793, CWA 16393, CWA 16335). We know firsthand the risks to your scientists, public health and national security. We can lead your Ministry or Agency through the process of stakeholder buy-in for regulatory reform and we can lead you through the creation of your own biorisk management guidelines or the adaptation (or adoption) of guidelines proven successful in other locations.

Campus Planning & Flow Analysis

Poorly designed public health campuses and agricultural laboratories have infectious samples, contaminated waste and infected animals crisscrossing the property. In addition to the obvious inefficiency, this presents significant risk of infectious disease exposure to staff, visitors and patients.

Inspirion staff members have developed long-term campus plans for many national public health laboratories. We group and consolidate similar functions to increase efficiency and minimize safety and security risks. We develop access controls appropriate to the organisms your organization handles and we develop waste management plans that decrease waste handling and ensure safe, rapid inactivation. We work with laboratory architects and planners to ensure that campus safety and security risks are fully identified, appropriate safety and security equipment is included in the design and that our clients are adequately prepared to confidently manage the risks on their property.

Laboratory Biosecurity & Pathogen Access Control

Even in a well-secured facility, infectious agents can be stolen or diverted. Poorly cataloged and monitored repositories can have samples removed with no one’s awareness. Remember the anthrax letters of 2001 in the US? Postal workers and civilians were infected. The US mail was shut down of a short period. National security was in jeopardy. The FBI says all this happened because infectious organisms were surreptitiously removed from a laboratory.

Inspirion Biosciences has supported almost every one of our BSL-3 clients with implementation of physical access controls and security monitoring for their repository. For those with specialized requirements, we have close relationships with vendors for pathogen access control software as well as repository management and relocation services. From client to client, the problems may be similar but the solutions are unique. Our experts will guide you to the most cost effective solution to ensure the safety of your workers and the surrounding community.

Biorisk Optimization of the Built Environment

In existing operations where biorisk management hasn’t been properly considered, workflow, sample processing, equipment maintenance and calibration, and waste management are inefficiently tangled and poorly controlled. The myriad of health, safety and security risks that exist in these circumstances jeopardizes public health as well as that of the scientific and non-scientific staff of the facility. Newly designed facilities can face challenges with these same activities, as well, if there was a failure to properly consider biorisk during the design process.

Inspirion Biosciences will help you avoid these problems and fix them if they already exist through:

  • Review of designs for new construction and renovated space to ensure compliance with biorisk guidelines;
  • Review of laboratory, facility and campus designs to ensure they account for all processes and to verify that workflow is optimized.
  • Inclusion of modern technologies and reagents in the design and floor plan in order to economize space, optimize manpower and minimize the creation of hazardous waste.

Biorisk Program Review & Development

A national audit or inspection that identifies the same findings and observations we typically identify may result in significant fines or laboratory closure. Health Ministries and subordinate laboratories in relatively few countries possess a written biorisk management program. They have no biological safety officer with dedicated responsibilities for health protection of laboratory staff and surrounding community. In most instances where organizations DO have a written program, it hasn’t been reviewed in years and, consequently, it no longer reflects the priorities, processes or management structure of the organization. In both situations, the organization is not in compliance with internationally accepted best practices. Staff members, visitors and the general public are at significant risk of exposure to potentially infectious materials.

Inspirion will help you identify suitable candidates to serve as biological safety officers in your facility. We’ll train these individuals to perform their job and monitor their performance. We’ll review your existing biorisk management program documentation. We commonly find dozens of inconsistencies and shortcomings requiring immediate attention. We’ll work with you to create or adjust policy statements, program plans, procedures and protocols so your program documentation is properly aligned and reflects the layout and design of your laboratory. We’re happy to train you to perform these activities for yourself. Don’t wait to contact us, for newly constructed facilities these documents must be revised and staff must be trained long before occupancy if work is to flow smoothly.

  • Do you have concerns about the effectiveness of your national regulatory framework for biosafety and biosecurity?
  • Does your research or public health laboratory campus have a long-term plan for efficient space utilization?
  • Does your facility or laboratory require renovation?
  • Does your organization have a biosafety officer?
  • Do you have a written biorisk management program in your laboratory?
  • Are continuing staff training programs in place to inform new employees and update to the latest biosafety practices?

These problems won’t fix themselves. Contact us—we’re ready to help.

BioRisk. Managed. TM

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