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Regulations for safety in biological plants

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Regulations for safety in biological plants

  1. 1. REGULATIONS FOR SAFETY IN BIOLOGICAL PLANTS (in respect of biohazards and biosecurity) BY: ABDULRAHMAN MOHAMMED (L-2012-V-21-D)
  2. 2. Contents  Definitions  Safety basics in biological plants  Biosafety in lab.  Personal biosafety  National regulations  International regulations
  3. 3. Definition  Biohazard: An agent of biological origin that has the capacity to produce deleterious effects on humans, i.e. microorganisms, toxins and allergens derived from those organisms; and allergens and toxins derived from higher plants and animals.  Biosecurity: Control of accidental and deliberate release of biohazardous material.  Biosafety: The containment principles, technologies and practices that are implemented to prevent the unintentional exposure to pathogens and toxins, or their accidental release.  Biologicals: are medicinal preparations made from living organisms and their products including serum, vaccines, antigens, antitoxins, blood and other plasma derivatives etc.
  4. 4. Safety basics in biological plants  Why biosafety practice in the facility? Protection of: Personnel  “products” co-workers lab support personnel environment
  5. 5. Safety basics in biological plants  Includes:  Biosafety in lab (production plant).  Personal biosafety
  6. 6. Biosafety in lab (production plant).  There are three principal steps for biosecurity  Physical Segregation: Prevent contamination.  is the most important and effective step. It is the strongest form of biosecurity and where effort should be placed if at all possible.  Cleaning: Remove contamination.  is the next most effective step. If all dirt is removed, there is little left for the microbes to be carried by.  Disinfection: Kill any remaining microbes.  is important but is the least reliable step of biosecurity. Its effectiveness depends on many factors, in particular the quality of the cleaning process.
  7. 7. SEGREGATION  Segregation: means keeping potentially infected persons and animals and contaminated objects away from uninfected animals and objects.  This requires a barrier, either actual or conceptual.  Nothing crosses the barrier unless it has to.  The barrier can be:  physical (fence),  temporal (time between visits) or  procedural (changing footwear and outer clothes)  Perimeter is best marked by a fence, but this is not always possible Limited and controlled access points (lock the gate).
  8. 8. Relation of risk groups to biosafety levels, practices and equipment Risk group Biosafety level (BSL) Laboratory type Lab. practice Safety equipment 1 Basic BSL- 1 Basic teaching and research Good microbiol. techniques (GMT) None, open bench work 2 Basic BSL- 2 Diagnostic services and research GMT + protective clothing biohazard sign Open bench plus bio – safety cabinet (BSC) for potential aerosols 3 Containment BSL- 3 Special diagnostic services and research As BSL-2 plus special clothing controlled access directional airflow Biosafety cabinet and/or other primary devices for all activities 4 Maximum Containment BSL- 4 Dangerous pathogen units As BSL-3 plus airlock entry, shower exit and special waist disposal Class-3 BSC or positive pressure suites in conjunction with class-2 BSCs, double ended autoclave trough the wall and filtered air
  9. 9. CLEANING  Cleaning means that the surfaces of the object must be visibly clean with no dirt left that is visible to the eye. This cannot be done with a garden spray / knapsack sprayer.  Cleaning needs effort.  Scrubbing brushes for smaller items such as boots and high pressure washers for bigger items such as vehicles High pressure = 110-130 bar  Cleaning with a detergent/disinfectant solution is OK, but it must be CLEAN afterwards as well as disinfected.
  10. 10. DISINFECTION  There are many disinfectants capable of inactivating the microbes.  The important elements are that they be used at the correct concentration and be in contact with the clean surface for long enough to act.  Time required depends on concentration up to a certain limit, temperature and contamination.  Disinfection can be improved by DRYING, or at least leaving the cleansed and disinfected object overnight to dry itself.
  11. 11. DISINFECTION  Disinfection kills a percentage of microbes not an absolute amount  Has to get the microbial contamination level to below an infectious dose to be fully effective  Needs the right concentration for the right time at the right temperature  Needs disinfectant to not be inactivated by other materials
  12. 12. Personal Biosecurity  Inner layer:  Tyvek suit underneath waterproof outer-wear  Inner layer of gloves in case outer layer tears  Outer layer:  Latex/nitrile gloves  Wellingtons with plastic over-boots to reduce dirt on boots, facilitating cleaning Water proof outer-wear  Hat/hood
  13. 13. Personal Biosecurity  Wear personal protective equipment  Face mask:  Goggles, face shield, or protective glasses  Gloves(need not be sterile)  Long-sleeve gown or overall (plastic apron if splashing is foreseen.
  14. 14. Personal safety recommendations in lab  1)Coverall  2)Hair cover  3)Plastic apron  4)Boot covers  5)Mask-fit the mask making sure it is secure around the face, especially around your nose  6)Goggles  7)Finally put on your gloves  8)Ideally wear two sets of gloves (making sure that the cuffs of the outer gloves go up and over the cuffs of your coverall)
  15. 15. Laboratory BIOSECURITY In Biological Plant  Risk assessment  An analysis of the probability and consequences of loss, theft, and misuse of microorganisms and biological materials.  Is a coordinated approach that enables the appropriate selection of measures to ensure reasonable and adequate laboratory security with out unduly affecting the scientific work.
  16. 16. Primary factors to consider in Risk Assessment:  1. Agent hazards (risk group)  2. Laboratory procedure hazards  3. Hazards associated with work practices.
  17. 17. Pathogen risk assessment  To analyze the biological risk, we must take into account:  Pathogenicity/infectivity  Virulence/lethality  Infective dose  Therapy/Prophylaxes  Epidemic potential  Resistance  Survival in the environment  Geographic spread (endemic)  Mode of transmission
  18. 18. Hazards associated with Work Practices, Safety Equipment and Facility Safeguards  1st line: Conscientious and proficient laboratory staff reduce the inherent risks that attend work with hazardous agents.  2nd line: Safety equipment remove or minimize the exposures to hazardous biological materials(BSCs).  3rd line: Suitable design and construction of the facilities contribute to the laboratory workers‘ protection.
  19. 19. Biological waste  In the lab, waste must be contained in a biohazard box with an autoclavable biohazard bag (usually yellow).  Inactivate liquids either chemically (e.g., with bleach) or autoclave.  Sterilize solids by autoclaving, then transfer into a different bag (red white) to indicate that the waste has been deactivated.  Special treatment for radioactive waste and waste of a biosafety level of 3 and higher.
  20. 20. Essential Building Principles  Primary containment barrier is the first barrier between agent and man (PPEs such as gloves, gowns, masks, biosafety cabinets, respiratory protection etc.)  Secondary containment barrier is the barrier between agents and environment (airtight rooms, air handling and filtration, air locks, showers, laundry, sewage treatment, waste disposal, sterilizers, redundant services as well as equipment and material niches.  Tertiary containment barrier represents an additional organizational barrier with the physical operation with items such as walls, fences, security, quarantine and animal exclusion zones.
  21. 21. Biosafety Principles  Substitution (replace hazardous material)  Technical safety measures (engineering controls)  Facility design  Directional airflow, ventilation  Isolators for animals  Organizational measures  SOP  Practices, procedures  Training  Access control  Personal Protective Equipment  Does not necessarily eliminates the hazard!!
  22. 22. Good Manufacturing Practices  The Good Manufacturing Practices (GMP) are part of quality assurance that ensures that biological products are produced consistently and controlled in accordance with the appropriate quality standards.  These standards depend on the intended use of the product and the requirements issued by the health authorities (WHO, MOH) or the product specification.GMP applies to both production and quality control laboratory.  Purpose  To ensure that the product is safe and effective for the end user
  23. 23. REGULATIONS AND LEGAL FRAMEWORK FOR BIOLOGICAL PLANT National Regulations (India)  India ratified the Cartagena Protocol on Biosafety in January 2003.  India ratified the Convention on Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxic Weapons and their Destruction in July, 1974.
  24. 24. Acts/Rules - Biosafety Regulation  Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms (Genetically Engineered Organisms or Cells, 1989 under the EPA (1986) known as ‘ Rules 1989’ by MoEF.  The Biological Diversity Act, 2002 by MoEF  Plant Quarantine Order, 2004 by NBPGR under MoA  Seed Policy, 2002 by MoA  DGFT Notification Relating to Inclusion of GM Policy in Foreign Trade Policy (2006-09) by MoC&I  Food Standards and Safety Act, 2006 by MoH&FW  Drugs and Cosmetics Amendment Act, 1972 by MoH&FW
  25. 25. National Institute of Biologicals (India)  Registered in January 1992 ( vide No. S-22590) under the Societies Registration Act 1860.  National Institute of Biologicals (NIB) strives to fulfill the national requirement for assuring the quality of biologicals to safeguard public health.  The Institute is committed to comply with the requirements of ISO/IEC 17025: 2005 to assure accurate and reliable results.  NIB has established systems and procedures to review the quality objectives from time to time thereby continually improving the effectiveness of the quality management system.
  26. 26. INSTITUTIONAL BIOSAFETY COMMITTEE (IBSC) Constituted by an occupier or any person including R&D institutions handling microbes. Comprises Head of Institution, scientists doing related work, medical experts and DBT nominee Assists the occupier or any person including R&D institution prepare an emergency plan as per guidelines of RCGM Copies of emergency plan to be made available to District Level Committee/State Biotechnology Coordination Committee and the Genetic Engineering Approval Committee (GEAC)
  27. 27. INTERNATIONAL INSTITUTIONS AND REGULATIONS  1. International Federation of Biosafety Association.  2. ISO (international organization for standardization).
  28. 28. Declaration of International Federation of Biosafety Association on Advancing Global Biosafety and Biosecurity 2011, the year of building international biosafety communities Longer-term goals • Promoting biosafety education, particularly of the younger generation, involving curriculum development within a common framework and a common methodology for evaluation. • Supporting appropriate and practical legislative framework development. • Developing a strategy to obtain funding for applied biosafety research programs
  29. 29. Declaration of International Federation of Biosafety Association on Advancing Global Biosafety and Biosecurity Short term goals • Raising awareness from the political and public perspectives, and encouraging collaboration among the human and animal health communities • Developing sustainable biosafety associations and mapping gaps and needs • Providing advice to the competent national authorities and services for the improvement of efficient waste management (through disseminating knowledge of appropriate systems, tools and technologies for public and veterinary health environments). • Promoting human and laboratory capacity building with proper identification of gaps and needs (using the best available concepts, principles and practices)
  30. 30. ISO  ISO (International Organization for Standardization) is the world’s largest developer of voluntary International Standards with a current portfolio of over 19 700 documents providing benefits for business, government and society. ISO is a network comprising the national standards institutes of 163 countries.  The document relevant to biological plants standards is ISO/IEC 17025:2005(E).
  31. 31. References • ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, second edition. • WHO/CDS/EPR/2006.6. Biorisk management Laboratory biosecurity guidance. • http://www.nib.gov.in (Indian institute of biologicals). • http://www.iahvb.co.in (Institute of animal health and veterinary biologicals)
  32. 32. THANK YOU FOR LISTENING

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