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New WHO Biosafety Guide Related To Coronavirus (2019-nCoV): Are You Ready?

The new WHO Guide “Laboratory biosafety guidance related to the novel coronavirus (2019-nCoV)” of 12th February 2020 related to testing on clinical specimens from patients with coronavirus (2019-nCoV) aims to be a biosafety good practices framework within diagnostic and clinical laboratories. The situation we are in requires immediate actions to adapt laboratories to the biosafety standards this guide recommends. 

The key points of this guide are:

  • Each laboratory must conduct an institutional risk assessment to ensure that it is competent. The procedures must also undergo a risk assessment. Operations must only be performed by personnel with proven capability and in strict observance of the relevant protocols,
  • Prior to their inactivation the sample’s initial processing must be done in a qualified biosafety cabinet,
  • Work such as sequencing or NAAT (Nucleic Acid Amplification Test) must be undertaken in facilities and following procedures equivalent to BSL-2 (Biosafety Level-2). Works such as virus cultures, isolations or neutralisations in BSL-3 (Biosafety Level-3) laboratories,
  • Appropriate disinfectants are those with proven activity against viruses such as hypochlorite (1,000 ppm – 0.1% – for general surface disinfection and 10,000 ppm – 1% – for blood spills disinfection), ethanol (62-71%), hydrogen peroxide, quaternary ammonium compounds, and phenolic compounds. Attention must be paid to the contact time, the dilution and the preparation date of the mixture,
  • Samples from suspected and confirmed cases must be transported as UN3373 (Biological. Substance, Category B). Viral cultures or isolates must be transported as UN2814 (Infectious substance, which affects humans. Category A).

An important part of ensuring laboratory biosafety is the facility’s design and equipment. Therefore, special attention must be paid to the following requirements:

  • Ample space and a designated sink with appropriate access restriction must be provided,
  • Doors must be properly labelled. Walls, floors, and furniture must be smooth, easy to clean, waterproof, and chemical and disinfectant resistant,
  • Airflow in ventilation, and air conditioning systems (especially when installed later) must be checked in order not to compromise the workers’ safety. The airflow speeds and directions must be taken into account, and turbulent flows must be avoided; this also applies to natural ventilation,
  • The area and facilities must be adequate and appropriate to safely handle and store infectious samples and hazardous materials, such as chemicals and solvents,
  • The building must have facilities to eat and drink outside the laboratory, and first aid facilities,
  • The laboratory must have waste decontamination methods (e.g., disinfectants and autoclaves),
  • When designing a laboratory, waste management must be considered. Security systems must include fire, electrical emergencies and incidents based on risk analysis.
  • Electricity and lighting supply must be reliable and adequate to enable a quick and safe emergency exit,
  • The risk analysis must cover emergency situations. It must include geographic/meteorological context.

ASSI, a Trescal company with a long history within the pharmaceutical and hospital sector. We offer specialised consulting and qualification services related to:

  • Processes and facilities risk analysis,
  • Rooms, ICU’s, biosafety cabinets qualifications,
  • Sterilisation equipment qualifications,
  • Instrumentation calibration.

We invite you to take a look at our range of services. We approach every project individually and provide solutions tailored to your needs. Ask us any question you might have.

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