Cell Sorting and Biosafety - Flowcytometry News...Cabinet placement can influence safety uK laws The...
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Biosafety and GMM* On the contained use of genetically modified micro- organisms Control of Aerosol Dissemination As described in Annex IV of the European Directive 2009/41/EC 2009/41/EC 2009/41/EC 12469:2000 European Directive European Directive Cell Sorting and Biosafety Protecting you and your research samples Biosafety is the foundation stone of all biomedical laboratory work. As a Biosafety Officer/ Principle Investigator, you must ensure compliance with all the relevant National Biosafety Regulations. In this short document, BD look at the Regulatory Frameworks directives and standards that pertain to this important area of Biosafety. WHAT IS A EUROPEAN DIRECTIVE? • Character of a law issued by the European Commission • Has to be transposed into national laws in each member state to become effective EUROPEAN DIRECTIVES VERSUS NATIONAL LAWS • Member states transpose the directives into national laws to become effective • In some cases, member states require higher security measures for the lower biosafety levels • Specifically, aerosol dissemination has been addressed. This is most important for using cell sorters with potentially biohazardous samples Conclusion © 2018 BD. BD and the BD Logo are trademarks of Becton, Dickinson and Company. BSL-1 BSL-2 BSL-3 BSL-4 WHO HOW TO DO General Biosafety Classification Personal protection from risks related to exposure to biological agents at work Classifications: General rules for lab work Risk Assessment Embedded in Article 3 of European Directive 2000/54/EC German Laws Biostoffverordnung 15.07.2013 Transposes 2000/54/EC into national German law Norms for Biological Safety Cabinets BSC Cell Sorters in Biosafety Cabinets The norm alone does not guarantee safety Cabinet placement can influence safety UK Laws The Genetically Modified Organisms (Contained Use) Regulations 2014, Fifth edition 2014, transposes 2009/41/ EC into UK law. Biosafety Levels have been first defined at the „Asilomar Conference“ in 1975 and have been used since then worldwide harmless for human health low risk effective prohylaxis/ treatment high individual risk, moderate community risk effective prophylaxis/ treatment serious individual risk, serious community risk no prophylaxis/ treatment Responsibility of Principal Investigator and Biosafety Officer What is the risk of infection? Route? Bugs in use, vectors/ plasmids? What are appropriate measures? BSC required? Handling of GMMs is more restricted than working with unmodified organisms to prevent spread into the environment • Aerosols • Waste Handling Amendments necessary due to growing knowledge about GMMs, 2009/41/EC is the newest directive (old ones were 90/219/EC and 98/81/EC, amended by EC 2000/608 and EC 2001/204) *Genetically modified microorganism 2000/54/EC 2000/54/EC European Directive European Directive No eating and drinking in a lab No mouth pipetting Cleaning procedures Lab design • Floor • Lab tables • Cupboards Good laboratory practice A higher biosafety level of containment may be required during sorting than the one recommended for handling the infectious material alone. • For example: BSL2 with enhanced precautions • Depends on the biological agent and risk assessment Minimise is not the same as prevent Defines a BSC or a comparable protective device as required for BSL-2 work when aerosol production can be expected Health and Safety Executive together with the „Scientific Advisory Committee on Genetic Modification” issued “The SACGM Compendium of guidance”. Similar to the German Technical Rules for working with Biological Agents. Identical with the EU Directive Control of Substances Hazardous to Health (COSHH) guidelines, Sixth edition 2012 TRBA-100 requires the prevention of aerosol dissemination in BSL-2 Table 1A. Containment and other protective measures for laboratory activities Part 2 Containment measures. Table 1a Containment measures applicable to contained use involving micro-organisms in laboratories Part 3. Containment measures for laboratory activities involving GMMs (Schedule 8 Table 1a) PART II. Containment measures for health and veterinary care facilities, laboratories and animal rooms BSL-2 BEFORE 2000 BSL-3 SINCE 2000 SACGM Activities involving biological agents of risk group 2 where a hazard from bioaerosols can be expected must be carried out in a microbiological safety workbench or comparable facility (e.g. extractor with high-efficiency particulate filter). Only National standards Deutsche Industrienorm 12950 Germany British Standard 5726 UK AFNOR NF X 44-201 France National Norms for BSC Parts 2 and 4 of BS 5726:2005 regarding the correct placement of a BSC are extending the content of EN 12469:2000 DIN 12980 BSC for work with cytostatic agents (production of anti-cancer drugs) requires a higher protection level than defined for standard BSCs in EN 12469:2000 Technical Rules for working with biological agents • All biological samples from humans (body fluids, tissues, cell cultures) that are not tested must be handled as potentially biohazardous. Such samples should be handled as BSL-2 • Only if such samples have been tested negative for HIV, HCV and HBV (Hepatitis B and C) can they be handled as BSL-1. Technical Rules for working with Biological Agents 100 (National law, gives more detailed instructions and expands the Annex II of the German Biostoffverordnung) The open handling of biological agents of risk group 3 or materials where there is good reason to believe that they contain such agents must be carried out in a safety workbench of class 1 or 2 or in a device which is comparable in terms of personal protection EN 12469:2000 Note that it does specifically say „or in a comparable facility/ device“ Local rules may require control of aerosol dissemination for any Level 2 work with potential aerosol generation Customers have to carefully read their local legislation It is important to understand your local regulations, laws and standards to understand what protection level is required EN European Norm Describes in detail • Manufacturing materials • Manufacturing guidelines: painting, no hard edges, lighting, noise levels • Testing procedures to demonstrate safety • Certification procedures during operation • Cleanability Non conforming situations can occur during work in a tissue culture cabinet designed and built to the norm Location of a BSC is important. External airflows may influence the protection, even if the cabinet is fully compliant with the norm Can a sorter in a hood fully comply with EN12469:2000? NO, as this is no longer a product as described in the norm! What can a manufacturer claim? We can test personal, product, and environmental protection according to the procedures defined in the norm ? ? Biosafety guidelines request to work in a BSC or in a comparable facility with the same level of protection Next month BD will review its products that can help Biosafety Officers and Principle Investigators comply with these standards. Learn more? bdbiosciences.com/eu
Transcript of Cell Sorting and Biosafety - Flowcytometry News...Cabinet placement can influence safety uK laws The...
Biosafety and GMM*
On the contained use of genetically modified micro-organisms
Control of Aerosol Dissemination
As described in Annex IV of the European Directive 2009/41/EC
2009/41/EC
2009/41/EC
12469:2000
European Directive
European Directive
Cell Sorting and Biosafety Protecting you and your research samples
Biosafety is the foundation stone of all biomedical laboratory work. As a Biosafety Officer/Principle Investigator, you must ensure compliance with all the relevant National Biosafety Regulations.
In this short document, BD look at the Regulatory Frameworks directives and standards that pertain to this important area of Biosafety.
WhAt IS A EuROPEAN DIRECtIvE?• Character of a law issued by the European Commission
• Has to be transposed into national laws in each member state to become effective
EuROPEAN DIRECtIvES vERSuS NAtIONAl lAWS• Member states transpose the directives into national laws to become effective
• In some cases, member states require higher security measures for the lower biosafety levels
• Specifically, aerosol dissemination has been addressed. This is most important for using cell sorters with potentially biohazardous samples
Conclusion
© 2018 BD. BD and the BD Logo are trademarks of Becton, Dickinson and Company.
BSL-1 BSL-2 BSL-3 BSL-4
WhO hOW TO DO
General Biosafety Classification
Personal protection from risks related to exposure to biological agents at work
Classifications:
General rules for lab work
Risk Assessment
Embedded in Article 3 of European Directive 2000/54/EC
German laws
Biostoffverordnung 15.07.2013 Transposes 2000/54/EC into national German law
Norms for Biological Safety Cabinets BSC
Cell Sorters in Biosafety Cabinets
the norm alone does not guarantee safety
Cabinet placement can influence safety
uK laws
The Genetically Modified Organisms (Contained Use) Regulations 2014, Fifth edition 2014, transposes 2009/41/EC into UK law.
Biosafety levels have been first defined at the
„Asilomar Conference“ in 1975 and have been used
since then worldwide
harmless for human
health
low risk effective
prohylaxis/treatment
high individual risk, moderate community risk
effective prophylaxis/
treatment
serious individual risk, serious
community risk no prophylaxis/
treatment
Responsibility of Principal
Investigator and Biosafety Officer
What is the risk of infection?
Route? Bugs in use, vectors/
plasmids?
What are appropriate measures?
BSC required?
handling of GMMs is more restricted than working with unmodified organisms to prevent spread into the environment
• Aerosols
• Waste handling
Amendments necessary due to growing knowledge about GMMs, 2009/41/EC is the newest directive (old ones were 90/219/EC and 98/81/EC, amended by EC 2000/608 and EC 2001/204)
* Genetically modified microorganism
2000/54/EC
2000/54/EC
European Directive
European Directive
No eating and drinking in a lab
No mouth pipetting
Cleaning procedures
lab design • Floor • Lab tables • Cupboards
Good laboratory practice
A higher biosafety level of containment may be required during sorting than the one recommended for handling the infectious material alone.
• For example: BSL2 with enhanced precautions
• Depends on the biological agent and risk assessment
Minimise is not the same as prevent
Defines a BSC or a comparable protective device as required for BSl-2 work when aerosol production can be expected
health and Safety Executive together with the „Scientific Advisory Committee on Genetic Modification” issued
“the SACGM Compendium of guidance”. Similar to the
German technical Rules for working with Biological
Agents.
Identical with the Eu Directive
Control of Substances hazardous to health (COShh) guidelines, Sixth edition 2012
TRBA-100 requires the prevention of aerosol dissemination in BSl-2
Table 1A. Containment and other protective measures for laboratory activities
Part 2 Containment measures. Table 1a Containment measures applicable to contained use involving micro-organisms in laboratories
Part 3. Containment measures for laboratory activities involving GMMs (Schedule 8 Table 1a)
PART II. Containment measures for health and veterinary care facilities, laboratories and animal rooms
BSL-2
BEFORE 2000
BSL-3
SINCE 2000
SACGM
Activities involving biological agents of risk group 2 where
a hazard from bioaerosols can be expected must be carried
out in a microbiological safety workbench or comparable facility (e.g. extractor with high-efficiency
particulate filter).
Only National standards
Deutsche Industrienorm 12950 Germany
British Standard 5726 uK
AFNOR NF X 44-201 France
National Norms for BSCParts 2 and 4 of BS 5726:2005 regarding the correct placement of a BSC are extending the content of EN 12469:2000
DIN 12980 BSC for work with cytostatic agents (production of anti-cancer drugs) requires a higher protection level than defined for standard BSCs in EN 12469:2000
technical Rules for working with biological agents
• All biological samples from humans (body fluids, tissues, cell cultures) that are not tested must be handled as potentially biohazardous. Such samples should be handled as BSL-2
• Only if such samples have been tested negative for HIV, HCV and HBV (Hepatitis B and C) can they be handled as BSL-1.
technical Rules for working with Biological Agents 100 (National law, gives more detailed instructions and expands the Annex II of the German Biostoffverordnung)
the open handling of biological agents of risk group 3 or materials
where there is good reason to believe that they contain such agents must be carried out in a
safety workbench of class 1 or 2 or in a device which is comparable in
terms of personal protection
EN 12469:2000
Note that it does specifically say „or in a comparable facility/
device“
Local rules may require control of aerosol dissemination for
any level 2 work with potential aerosol generation
Customers have to carefully read their
local legislation
It is important to understand your local regulations, laws and standards to understand what
protection level is required
EN
European Norm
Describes in detail
• Manufacturing materials
• Manufacturing guidelines: painting, no hard edges, lighting, noise levels
• Testing procedures to demonstrate safety
• Certification procedures during operation
• Cleanability
Non conforming situations can occur during work in a tissue culture cabinet designed and built to the norm
Location of a BSC is important. External airflows may influence the protection, even if the cabinet is fully compliant with the norm
Can a sorter in a hood fully comply with EN12469:2000?NO, as this is no longer a product as described in the norm!
What can a manufacturer claim?We can test personal, product, and environmental protection according to the procedures defined in the norm
??
Biosafety guidelines request to work in a BSC or in a comparable facility with the same level of protection
Next monthBD will review its products that can help Biosafety Officers and Principle Investigators comply with these standards.
learn more? bdbiosciences.com/eu
