Fumigation of BSL-3 security rooms in the new Bioveta Biosafety Hall

15. 02. 2023

BLOCK has successfully completed and handed over the new Bioveta Biosafety Hall (BBH) designed for biotechnological production of veterinary products.

BLOCK® has successfully completed and handed over the new Bioveta Biosafety Hall (BBH) designed for biotechnological production of veterinary products. The hall is located on the Bioveta site next to the Bioveta Novelty Hall, implemented by BLOCK in 2018, and continues the Bioveta company development. For the time being, two floors of the four-storey building are used. The 2nd floor houses the biotech vaccine production and the 4th floor temporarily houses the QA (Quality Assurance) laboratories.

BLOCK® implemented complex delivery of the construction, processing of project documentation including delivery of installation of technical and technological units. The implementation also included modification of the affected outdoor areas and surfaces to ensure the continuity of the buildings with the surrounding roads, the performance of the necessary tests, revisions, validations, regulations and the implementation of a test run of at least 30 days. The works were carried out while the Bioveta site was in full operation.

The production work for biotechnological vaccine production on the 2nd floor is carried out in BSL-3 security, fully enclosed technology with compliance with the safety requirements of the law (especially HVAC). The complete cleanroom and process equipment are fumigatable with H2O2 vapours , as is the wastewater decontamination area located on the 1st floor.

In the Bioveta Biosafety Hall, we have implemented a total of 226 m2 clean rooms with BSL-3 security including a comprehensive vapour fumigation system H2O2

 

 

In order for work to take place in BSL secure areas, they must meet a number of criteria.

BSL (BioSafety Level) rooms are rooms with biological hazards. Biohazards are threats from substances of biological origin that pose a threat to animal and human health. Examples of items and substances that may pose a biohazard include medical waste or microbial samples (e.g. viruses or biological poisons). There are 4 levels of technical security for BSL laboratories/production facilities, namely BSL-1 "basic", BSL-2 "basic", BSL-3 "containment", BSL-4 "maximum containment". In order for work to take place in BSL containment areas, they must meet a number of criteria. A number of regulations address the issue of BSL. For example, the Czech standard "ČSN EN 12128, 09/1999 - Biotechnology - Laboratories for research, development and testing - Levels of containment" and "NV No. 361/2007 Coll., laying down conditions for occupational health protection". International standards include, for example, "WHO, Laboratory biosafety manual, 2004 (3rd edition)" or "Design course be 100% familiar with all these standards and prepare the entire project in accordance with them. For the BLOCK® group, our colleague Ing. Petr Jirkovsky, created an extensive manual summarizing the design and correct solutions of these spaces. In this document we also record our practical findings from the already implemented projects, which help us in solving other projects.

 

To give you an idea, when we designed the BSL-3 space with a comprehensive H2O2 vapor fumigation system in the BBH hall, we addressed the following HVAC principles, for example:

  • Rooms belonging to BSL-3 class laboratories are permanently under negative pressure (up to -50 Pa). During the fumigation process, a pressure of -10 to -15 Pa is maintained throughout.
  • There are always two HEPA filters in a row on the room exhaust.
  • There are tight flaps in the pipe (leak-tightness sheet-grade permeability).
  • Special elements are used.
  • The concept of the HVAC unit is designed with fumigation in mind.
  • The entire HVAC system and HVAC units must be resistant to hydrogen peroxide vapor.
  • Increased leakage class of the HVAC piping (leakage class min "C").
  • The ceiling is not light metal but "heavy" (BLOCK® modular ceiling system) due to the requirements for negative pressure (high room pressure).
  • HVAC units are backed up (this requirement is usually based on risk analysis). This means that there are two HVAC units in parallel, with the second one serving as a backup in case of failure of the first one.
  • The rooms of the BSL-3 outlets are designed as plugs (with 20 Pa overpressure) and managed from another HVAC unit.
  • The entire BSL-3 space in 2nd floor is now designed as a single device in principle in terms of air conditioning. The pre-treatment unit preheats the air in winter and dehumidifies it in summer and two separate circulation units operated 50/50 (so that in case of failure of one KLU the other one can keep the system at least in damped operation). Thus the whole facility is like one fumigation circuit.
  • Source of H2O2 vapors is distributed to individual rooms. The system is controlled by a humidity sensor located inside the HVAC pipeline.

 

Example of  H2O2 vapour distribution principles:

  • The hydrogen peroxide vapour distribution lines are divided into branches.
  • From each hydrogen peroxide vapour generator (Puriter) there is a branch line for the room or group of rooms. The generator may be common to several branches, in which case the branches are in different steps, i.e. they will not be decontaminated simultaneously.
  • Distribution points are terminated under the ceiling with DN 40 ball valve, 24 V DC control, 0-10 V control, clamp connection and distribution head
  • All pipe penetrations through walls into BSL-3 shall be provided with a tight O-ring grommet installed on both sides of the wall. Pipe penetrations through soffits into BSL-3 shall be provided with a tight O-ring grommet installed on the underside of the soffit.

 

Example of layouts and built-ins principles:

  • Built-in spaces with parameters for BSL-3 with anticipated H2O2 vapor fumigation are designed in a complete system of metal non-load bearing structures with increased requirements for their fabrication. These BLOCK® structures interlock with each other with interconnections to the floor structure to meet the highly demanding cleanliness and tightness requirements of the work environment. Once assembled, all joints are sealed with silicone sealant.
  • Two-stage personnel and material clearances are standard on the BSL-3. We always design a decontamination shower at the exit of the underground level.
  • Structural H2O2 Resistant
  • Tight design of clean rooms and HVAC system.
  • Tight doors and other elements.

 

 

Fumigation with hydrogen peroxide vapour does not leave residues because hydrogen peroxide decomposes into oxygen and water after decontamination.

One of the requirements for BSL-3 facilities is that they must be fumigated (decontaminated) on a regular basis. This is a cleaning process that removes biological contamination or the possibility of contamination. Within the BLOCK® Group, we have developed an integrated system for decontaminating buildings and equipment with hydrogen peroxide vapour for this purpose. The source of the hydrogen peroxide vapour is the generators (Puriters), which are located outside the decontaminated areas in the technical or unclassified area. These are mobile devices that connect to the distribution pipeline. The hydrogen peroxide vapour is distributed to the decontaminated areas via a separate pipework leading from the Puriters to the nozzles on the ceiling of each room (or to the nozzles located in the individual equipment). The removal of contaminated air from the individual rooms is via an exhaust pipeline (HVAC). Control is possible from the master control station or directly from the Puriter. The decontamination process can also be monitored from a connected mobile phone. Relative humidity and temperature are monitored at the outlet of each fumigated room and are the control variables for determining the hydrogen peroxide vapor decontamination process. The system can be supplemented with monitoring of hydrogen peroxide vapour concentrations and the data can be collected in a higher-level system.

The use of hydrogen peroxide vapour results in surface sterilisation which reduces biological contamination by up to 6 orders of magnitude. This method leaves no residue because the hydrogen peroxide decomposes into oxygen and water after decontamination.

 

 

Technological process of decontamination (fumigation) in BSL-3 in the BBH hall

 

A) PREPARATION OF THE FUMIGATION AREA

Before adjusting the air parameter (temperature humidity) the following will be done:

  • Shutdown of technological processes
  • Fitting the hydrogen peroxide supply assembly to the built-in ceiling outlet
  • Abandonment of staff
  • Closing the tight door at the BSL-3 border
  • Placement of Puriters in the appropriate places

 

Subsequently, the premises will be treated by the HVAC:

  • Switching off humidifiers
  • Air heating to approx. 31°C

 

B) TRANSITION FROM WORKING OPERATION TO THE FUMIGATION PROCESS

  • The HVAC mode switches from the operating mode to the idle mode, the supply and exhaust fans of the units are switched off.
  • The air supply dampers in each room are closed tightly.
  • The tight flaps on the main exhaust duct behind the second stage HEPA filter are closed.
  • The shut-off valves on the hydrogen peroxide mixture inlet in front of each room are opened.
  • Generators are powering up.
  • The dampers on the fumigation outlet are opened and the fumigation outlet fan (mounted on the roof) is started and blows the exhaust air to the outside environment.
  • After the pipeline is heated, the developer begins to distribute the hydrogen peroxide mixture.
  • The pressure regime (gradients between rooms) is levelled after the HVAC unit is switched off and is controlled by the fumigation process. A negative pressure of -10 Pa to -15 Pa is maintained in the rooms by means of a control damper on the fumigation extract at each individual room. The pressure parameter is measured against a pressure zero. A differential pressure sensor will be in each fumigated room.

 

C) THE DECONTAMINATION PROCESS ITSELF

               

D) VENTILATION OF THE AREA AFTER FUMIGATION

 

  • The hydrogen peroxide generator stops the preparation of the pressurized air/peroxide mixture, but continues to blow separate compressed air into the rooms for the initial ventilation of H2O2 out of the rooms.
  • The duration of this process will be set according to the test operation based on monitoring the decrease in H2O2
  • Thereafter, the activity of the developers is terminated.
  • The flaps on the peroxide mixture supply to the rooms are closed.
  • The flap on the fumigation air exhaust is closed.
  • Fume extraction fan dampers closed.
  • The fumigation exhaust fan is switched off.
  • The pre-treatment air handling units are started up, the circulation air handling units are put into operation in "ventilation after fumigation" mode, also as exhaust air handling units.
  • Monitoring of the ppm level will be on the ppm sensor in the vent duct on the route to the V2 fan.

 

 

A big thank you to the entire Bioveta Biosafety Hall implementation team, with each member looking for an efficient way to implement the work and in the end this was also highly praised by Bioveta representatives as the best implementation so far.

Photogallery

Fumigation of BSL-3 security rooms in the new Bioveta Biosafety Hall

15. 02. 2023

BLOCK has successfully completed and handed over the new Bioveta Biosafety Hall (BBH) designed for biotechnological production of veterinary products.

BLOCK® has successfully completed and handed over the new Bioveta Biosafety Hall (BBH) designed for biotechnological production of veterinary products. The hall is located on the Bioveta site next to the Bioveta Novelty Hall, implemented by BLOCK in 2018, and continues the Bioveta company development. For the time being, two floors of the four-storey building are used. The 2nd floor houses the biotech vaccine production and the 4th floor temporarily houses the QA (Quality Assurance) laboratories.

BLOCK® implemented complex delivery of the construction, processing of project documentation including delivery of installation of technical and technological units. The implementation also included modification of the affected outdoor areas and surfaces to ensure the continuity of the buildings with the surrounding roads, the performance of the necessary tests, revisions, validations, regulations and the implementation of a test run of at least 30 days. The works were carried out while the Bioveta site was in full operation.

The production work for biotechnological vaccine production on the 2nd floor is carried out in BSL-3 security, fully enclosed technology with compliance with the safety requirements of the law (especially HVAC). The complete cleanroom and process equipment are fumigatable with H2O2 vapours , as is the wastewater decontamination area located on the 1st floor.

In the Bioveta Biosafety Hall, we have implemented a total of 226 m2 clean rooms with BSL-3 security including a comprehensive vapour fumigation system H2O2

 

 

In order for work to take place in BSL secure areas, they must meet a number of criteria.

BSL (BioSafety Level) rooms are rooms with biological hazards. Biohazards are threats from substances of biological origin that pose a threat to animal and human health. Examples of items and substances that may pose a biohazard include medical waste or microbial samples (e.g. viruses or biological poisons). There are 4 levels of technical security for BSL laboratories/production facilities, namely BSL-1 "basic", BSL-2 "basic", BSL-3 "containment", BSL-4 "maximum containment". In order for work to take place in BSL containment areas, they must meet a number of criteria. A number of regulations address the issue of BSL. For example, the Czech standard "ČSN EN 12128, 09/1999 - Biotechnology - Laboratories for research, development and testing - Levels of containment" and "NV No. 361/2007 Coll., laying down conditions for occupational health protection". International standards include, for example, "WHO, Laboratory biosafety manual, 2004 (3rd edition)" or "Design course be 100% familiar with all these standards and prepare the entire project in accordance with them. For the BLOCK® group, our colleague Ing. Petr Jirkovsky, created an extensive manual summarizing the design and correct solutions of these spaces. In this document we also record our practical findings from the already implemented projects, which help us in solving other projects.

 

To give you an idea, when we designed the BSL-3 space with a comprehensive H2O2 vapor fumigation system in the BBH hall, we addressed the following HVAC principles, for example:

  • Rooms belonging to BSL-3 class laboratories are permanently under negative pressure (up to -50 Pa). During the fumigation process, a pressure of -10 to -15 Pa is maintained throughout.
  • There are always two HEPA filters in a row on the room exhaust.
  • There are tight flaps in the pipe (leak-tightness sheet-grade permeability).
  • Special elements are used.
  • The concept of the HVAC unit is designed with fumigation in mind.
  • The entire HVAC system and HVAC units must be resistant to hydrogen peroxide vapor.
  • Increased leakage class of the HVAC piping (leakage class min "C").
  • The ceiling is not light metal but "heavy" (BLOCK® modular ceiling system) due to the requirements for negative pressure (high room pressure).
  • HVAC units are backed up (this requirement is usually based on risk analysis). This means that there are two HVAC units in parallel, with the second one serving as a backup in case of failure of the first one.
  • The rooms of the BSL-3 outlets are designed as plugs (with 20 Pa overpressure) and managed from another HVAC unit.
  • The entire BSL-3 space in 2nd floor is now designed as a single device in principle in terms of air conditioning. The pre-treatment unit preheats the air in winter and dehumidifies it in summer and two separate circulation units operated 50/50 (so that in case of failure of one KLU the other one can keep the system at least in damped operation). Thus the whole facility is like one fumigation circuit.
  • Source of H2O2 vapors is distributed to individual rooms. The system is controlled by a humidity sensor located inside the HVAC pipeline.

 

Example of  H2O2 vapour distribution principles:

  • The hydrogen peroxide vapour distribution lines are divided into branches.
  • From each hydrogen peroxide vapour generator (Puriter) there is a branch line for the room or group of rooms. The generator may be common to several branches, in which case the branches are in different steps, i.e. they will not be decontaminated simultaneously.
  • Distribution points are terminated under the ceiling with DN 40 ball valve, 24 V DC control, 0-10 V control, clamp connection and distribution head
  • All pipe penetrations through walls into BSL-3 shall be provided with a tight O-ring grommet installed on both sides of the wall. Pipe penetrations through soffits into BSL-3 shall be provided with a tight O-ring grommet installed on the underside of the soffit.

 

Example of layouts and built-ins principles:

  • Built-in spaces with parameters for BSL-3 with anticipated H2O2 vapor fumigation are designed in a complete system of metal non-load bearing structures with increased requirements for their fabrication. These BLOCK® structures interlock with each other with interconnections to the floor structure to meet the highly demanding cleanliness and tightness requirements of the work environment. Once assembled, all joints are sealed with silicone sealant.
  • Two-stage personnel and material clearances are standard on the BSL-3. We always design a decontamination shower at the exit of the underground level.
  • Structural H2O2 Resistant
  • Tight design of clean rooms and HVAC system.
  • Tight doors and other elements.

 

 

Fumigation with hydrogen peroxide vapour does not leave residues because hydrogen peroxide decomposes into oxygen and water after decontamination.

One of the requirements for BSL-3 facilities is that they must be fumigated (decontaminated) on a regular basis. This is a cleaning process that removes biological contamination or the possibility of contamination. Within the BLOCK® Group, we have developed an integrated system for decontaminating buildings and equipment with hydrogen peroxide vapour for this purpose. The source of the hydrogen peroxide vapour is the generators (Puriters), which are located outside the decontaminated areas in the technical or unclassified area. These are mobile devices that connect to the distribution pipeline. The hydrogen peroxide vapour is distributed to the decontaminated areas via a separate pipework leading from the Puriters to the nozzles on the ceiling of each room (or to the nozzles located in the individual equipment). The removal of contaminated air from the individual rooms is via an exhaust pipeline (HVAC). Control is possible from the master control station or directly from the Puriter. The decontamination process can also be monitored from a connected mobile phone. Relative humidity and temperature are monitored at the outlet of each fumigated room and are the control variables for determining the hydrogen peroxide vapor decontamination process. The system can be supplemented with monitoring of hydrogen peroxide vapour concentrations and the data can be collected in a higher-level system.

The use of hydrogen peroxide vapour results in surface sterilisation which reduces biological contamination by up to 6 orders of magnitude. This method leaves no residue because the hydrogen peroxide decomposes into oxygen and water after decontamination.

 

 

Technological process of decontamination (fumigation) in BSL-3 in the BBH hall

 

A) PREPARATION OF THE FUMIGATION AREA

Before adjusting the air parameter (temperature humidity) the following will be done:

  • Shutdown of technological processes
  • Fitting the hydrogen peroxide supply assembly to the built-in ceiling outlet
  • Abandonment of staff
  • Closing the tight door at the BSL-3 border
  • Placement of Puriters in the appropriate places

 

Subsequently, the premises will be treated by the HVAC:

  • Switching off humidifiers
  • Air heating to approx. 31°C

 

B) TRANSITION FROM WORKING OPERATION TO THE FUMIGATION PROCESS

  • The HVAC mode switches from the operating mode to the idle mode, the supply and exhaust fans of the units are switched off.
  • The air supply dampers in each room are closed tightly.
  • The tight flaps on the main exhaust duct behind the second stage HEPA filter are closed.
  • The shut-off valves on the hydrogen peroxide mixture inlet in front of each room are opened.
  • Generators are powering up.
  • The dampers on the fumigation outlet are opened and the fumigation outlet fan (mounted on the roof) is started and blows the exhaust air to the outside environment.
  • After the pipeline is heated, the developer begins to distribute the hydrogen peroxide mixture.
  • The pressure regime (gradients between rooms) is levelled after the HVAC unit is switched off and is controlled by the fumigation process. A negative pressure of -10 Pa to -15 Pa is maintained in the rooms by means of a control damper on the fumigation extract at each individual room. The pressure parameter is measured against a pressure zero. A differential pressure sensor will be in each fumigated room.

 

C) THE DECONTAMINATION PROCESS ITSELF

               

D) VENTILATION OF THE AREA AFTER FUMIGATION

 

  • The hydrogen peroxide generator stops the preparation of the pressurized air/peroxide mixture, but continues to blow separate compressed air into the rooms for the initial ventilation of H2O2 out of the rooms.
  • The duration of this process will be set according to the test operation based on monitoring the decrease in H2O2
  • Thereafter, the activity of the developers is terminated.
  • The flaps on the peroxide mixture supply to the rooms are closed.
  • The flap on the fumigation air exhaust is closed.
  • Fume extraction fan dampers closed.
  • The fumigation exhaust fan is switched off.
  • The pre-treatment air handling units are started up, the circulation air handling units are put into operation in "ventilation after fumigation" mode, also as exhaust air handling units.
  • Monitoring of the ppm level will be on the ppm sensor in the vent duct on the route to the V2 fan.

 

 

A big thank you to the entire Bioveta Biosafety Hall implementation team, with each member looking for an efficient way to implement the work and in the end this was also highly praised by Bioveta representatives as the best implementation so far.

Photogallery

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