PowerPointPrsentation

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Biological Safety Instruction
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Definition

• Recombinant work generation of genetically
  manipulated
• organisms (--gt GVO), as well as their
  utilization, fermentation
• and storage.
• Must only be carried out in designated
  facilities, in accordance
• with 3 Nr. 4.
• Organism Every biological material, capable of
  reproduction and
• exchange of genetic information (--gt also i.e.
  viruses and cell
• cultures).
• GVO organism, whose genetic information was
  altered in a way
• that would normally not occur in Nature, i.e.
  by recombination
• and cross breeding.

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NO recombinant work...

• Utilization of purified DNA.
• Utilization of non-pathogenic, naturally
  occurring organisms.
• Exploitation of natural conjugation and
  transformation methods.
• Self-cloning, using non-pathogenic, naturally
  occurring organisms.
• Requirement Donor and recipient had not been
  genetically
• manipulated (--gt GVO)!!!

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Risk assessment and safety classification
Risk assessment of microorganism by
Robert-Koch-Institute http//www.rki.de/GENTEC/ZK
BS/ZKBS.HTM
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Risk assessment, i.e. Escherichia coli
E. coli is part of the physiological human
intestinal flora. Diseases caused, i.e. diarrhea,
enteritis, urinary tract infection, sepsis,
meningitis (infants only). Risk assessment S2
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Good microbiological code of practice

• Keep doors and windows closed.
• In the lab DONT eat, DONT drink und DONT
  smoke.
• In working area wear lab coat and/or protective
  clothing.
• NO mouth pipetting.
• Avoid utilization of syringes and cannulaes.
• Avoid formation of aerosol.
• After you are done sterilize and/or autoclave
  all cell cultures, work space and equipment
  (which had been in contact with the organisms).
• After you are done wash and desinfect hands.
• Keep work space clean and tidy store material
  and equipment no longer required in designated
  areas and cup boards.
• Regularly, verify identity of the biological
  material used.
• Annually oral biological safety instruction

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Operating instructions
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Autoclaving temperature vs. time dependence
Inactivation curve of Bacillus stearothermophilus
Sterilization time (in min)
? 121C/30min
Sterilization temperature (in C)
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Record keeping for recombinant work in
accordance to GENTAUFZV1

• Name and address of operator.
• Location of facility, designated for recombinant
  work.
• Name of project leader (PL).
• Name of authorized representative for biological
  safety (--gt BBS).
• For safety level S2 or higher list of all
  employees.
• Date of notification or announcement of
  recombinant work if applicable reference number
  and date of approval.
• Topic of recombinant work.
• Safety level.
• Start and closing date of recombinant work.
• Special incidents.
• 1 Absolutely no deletions. If necessary, clearly
  indicate date and kind of changes.

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Record keeping for recombinant work in
accordance to GENTAUFZV1

• List of genetically manipulated organisms (give
  names and all properties important for their risk
  assessment).
• Signature of operator or project leader.

Marahiel1 ? Shared ? AK66_Aufzeichnung-Plasmide ?
AK66-05/2004 Deadline for up-dated records
07/05/2004
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Hazardous material (1) ethidium bromide
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Hazardous material (2) acryl amide
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Biological Safety Instruction