Introduction
Biosafety and Biosecurity
Biosafety is “Keeping the bad bugs from the people”
Biosecurity is “Keeping the bad people from the bugs”
Together, they are referred to as Biorisk.
Biosafety roughly falls into two categories:
- Biosafety related to genetic modification
- Biosafety related to the use of dangerous pathogens
Both areas require oversight by a biosafety officer. However, in most countries the two areas are subject to two different sets of rules and laws, and fall under inspection authorities of different ministries. If you need advice or auditing of your local rules and guidelines, contact us.
Biosecurity roughly means that you need to take sufficient measures to prevent intended misuse and unwanted use of dangerous pathogens. Laws and rules for this aspect are not always worked out in detail. If you need advice in setting up biosecurity or auditing of your local situation, contact us.
Biological Safety
The key principle of Biological Safety (“biosafety”) is the protection of workers from the biohazards created by working with (micro)organisms. This is achieved by the implementation of safe laboratory operating procedures. Febris can assist in the attainment of this goal by the provision of training and advice on:
- Aerosols – their generation in the laboratory and how to protect against them
- The different types of Biological Safety Cabinets and related devices and how to use them correctly
- laboratory procedures for working with hazardous products, including biological agents,
- Appropriate Personal Protective Equipment (PPE)
- Risk Groups of microorganisms and what is required to work safely with each group
- Decontamination, disinfection, treatment and disposal of microbiological waste
- Handling microbiological incidents
- Working safely with human tissues and body fluids
- Safe handling of animals, including Laboratory Animal Allergies
Biological Security
Biological Security (“Biosecurity”) relates to those procedures aimed at preventing the intentional release of (micro)organisms into the community, including animals or plants. It includes the procedures necessary to ensure high risk microorganisms are not removed from microbiological laboratories. The threat of bioterrorism in the present political climate has contributed to growing concerns about biosecurity.
Biosecurity audit/assessment ….
Febris provides advice for First Responders, preparing guidelines and procedures, and contributed to national committees to ensure guidelines are in place for effective handling of any suspected biosecurity threats.
Biological Containment
Biological Containment (“Biocontainment”) encompasses the design and practices that ensure microorganisms are not unintentionally spread to the community or environment.
Febris provides advice on biocontainment principles, including:
- design standards
- laboratory practices
- safe working environments
Biosafety & Operations Manuals
In addition to implementing the legislative and Standards requirements on the construction, operation and maintenance of microbiological laboratories (PC2/BSL-2 through to PC4/BSL-4), each laboratory must have its own specific set of guidelines for their laboratory workers.
Using extensive knowledge of biological safety Standards and requirements of other organisations, Febris can assist in the preparation of biological safety manuals. We are also aware of the requirements of a range of legislation related to safety and building codes.
The Manual would usually be constructed with the following sections:
- General Information
- Personnel Procedures
- Operation & Safety Procedures
- Laboratory Standard Work Procedures
- Transfer and Transport of Biological Materials
- Incident Procedures
- Inactivation and Disposal of Waste
- …
Training Courses
We provide training in accordance with relevant legislation and standards to ensure the protection of laboratory workers and the general environment. This requires the adoption of different biosafety procedures according to the containment level of the laboratory and the type of work being conducted. We also cover the assessment of biological risks and their control.
Benefits of our training include:
- Qualified, experienced and renowned presenters
- Course developed by presenters, enabling immediate answers to questions
- Courses can be tailored specifically to your organisation’s needs
- Assessment of competency of participants and award of Certificates when competency standards are met
- Use of relevant current incidents to demonstrate PC principles
- Continually updated materials to reflect real world circumstances
Quality of training and management systems are the key components of personnel and institutional triumph. Biosafety education becomes a core element of institutional culture that will impact human behaviour, productivity and compliances. At Febris Biorisk Consult we offer various onsite, in-class or interactive on-line training that can be customized to meet your unique organizational needs, supporting and implementing your standards and procedures in compliance with biosafety legislation and requirements.
Training Programs:
- Biosafety regulations
- Biosafety practices
- Risk assessment
- Bloodborne pathogens
- Laboratory safety training
- Transportation of Dangerous Goods
CONSULTING
The consulting services offered by Febris Biorisk Consult cover a variety of biosafety areas. These various services can complement and support your current operations.
Febris Biorisk Consult can offer you:
- An off-site biosafety officer
- Biosafety program set up and review
- Advice on laboratory design
- Laboratory design review
- Implementation of Biorisk Management System – CWA 15793:2011
AUDITING
Febris Biorisk Consult has extensive working experience in the field of biosafety within Research and manufacturing organizations. Knowing the latest requirements and best practices enables us to provide reliable auditing and validation services. We stand behind all of our audits, training services and validations. It is our objective to become your partner in your biosafety and compliances initiative.
Febris Biorisk Consult provide:
- Regulatory compliances review
- Pre- regulatory inspection consultation
- Audits according CWA 15793:2011
- Inspections
- Emergency response procedures
- Integrated management systems
