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Containment
Biological containment laboratories are critical for vaccine development, diagnostic studies as well as basic research into human, animal and plant pathogens.
Laboratories wishing to operate safely and responsibly must implement management systems that ensure appropriate biosafety controls are identified and in place.
There are many different types of microorganisms which are handled in these laboratories, and each activity which is performed on the microorganism might pose a risk.
Therefore, the risks should be evaluated, so that measures can be put in place to protect both the workers and the environment from being infected.
Our Solutions
Bioquell HPV solutions are used in biological containment laboratories around the world to manage the risk of bio-contamination.
Bioquells HPV process can be applied to a variety of solutions;
- Ensuring the safe movement of materials exiting, and entering, a containment facility
- Routine management of the bio-containment laboratory environment – ensuring that there is a regular bio-decontamination of surfaces and air handling systems
- Emergency remediation solution in the event of a spillage of pathogens within the laboratory.
HPV bio-decontamination systems allow the users of the laboratory to deliver effective bio-decontamination cycles quickly and easily. Bioquell are able to offer a fully managed bio-decontaminaton service using our highly trained Professional Services engineers.
FAQs
Can Bioquell HPV be used in CL3 and CL4 laboratories?
Yes, Bioquell have experience of providing solutions in both CL3 and CL4 laboratories.
Can my laboratory be decontaminated after a spillage without accessing the laboratory to position equipment?
Yes. Bioquell can offer fixed or semi-permanent decontamination systems which allow complete room decontamination from outside the room.
Is there evidence that hydrogen peroxide vapor is efficacious against specific pathogens?
Yes. See Bioquell’s efficacy data sheets.
Technical
The Bioquell HPV process is optimized to provide effective and robust bio-decontaminaton cycles in the most complex areas. This process minimizes the time required for bio-decontamination by establishing scientifically proven1 microcondensation conditions which is key to the rapid deactivation of microorganisms followed by rapid, catalytically assisted, aeration which removes hydrogen peroxide, leaving surfaces free of any residue and ready for operations to recommence immediately. Bioquell HPV biodecontamination systems are designed to allow users to manage the bio-decontamination process easily. Bioquells dynamic parametric control algorithms allow bio-decontamination cycles to be instigated by end users without the need for complex cycle development. Bioquells fully managed bio-decontamination service (Bioquell RBDS) removes the need for client involvement in the process, Bioquell managing the process from inception to completion of a detailed final bio-decontamination report and certificate.
1 Unger-Bimczok B. et al. “The Influence of Humidity, Hydrogen Peroxide Concentration, and Condensation on the Inactivation of Geobacillus stearothermophilus Spores with Hydrogen Peroxide Vapor”, J. Pharm Innov (2008) 3:123 - 133
Entire hospital site
Whether due to an outbreak, maintenance, commissioning or decommissioning, hospitals occasionally have the requirement to decontaminate large areas rapidly, repeatably and effectively.
Bioquell is able to perform rapid, large scale hospital bio-decontamination, thereby minimizing downtime and eradicating problematic pathogens from the hospital environment.
Our Solutions
Bioquell’s Professional Service teams are able to link our systems in order to provide fully scalable deployment capacity, resulting in rapid deployment that minimizes downtime and thereby generates cost-benefits.
During commissioning and decommissioning projects, the hospital requires certification that the area has been decontaminated. Bioquell’s cycle verification using 6-log Geobacillus Stearothermophilus combined with our detailed reporting allows a hospital to satisfy these requirements.
FAQs
What is the maximum size room we can Bioquell?
We can decontaminate any area, as our Service hydrogen peroxide vapor (HPV) generators can be networked to ensure even vapor distribution throughout any area.
How long does a room take?
It will depend on the size of the room. Typically, a one bed room with no bathroom takes approximately 90 minutes to decontaminate. For a two bed room, this is extended to just over two hours.
Can you operate in a sensitive environment?
Yes, Bioquell engineers have extensive experience in operating with care and discretion in sensitive hospital environments?
Filter banks
Typically filter housings are decontaminated on a routine basis and/or when carrying out service, maintenance or filter replacement work.
Hydrogen peroxide vapor offers an effective and rapid method of decontaminating complex filter bank systems prior to implementing this type of work.
Our Solutions
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Complex filter housings can be decontaminated without the need to evacuate the room, floor or building
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By holding the whole decontamination cycle at negative pressure, the potential risk of hydrogen peroxide leakage is minimized
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Ability to validate the process utilizing log-6 biological indicators
- Once permanent connections have been installed on the filter housing then the process becomes a lot simpler and faster for subsequent decontaminations
FAQs
How can I validate a log-6 reduction in my filter banks?
Through gas cycle development (GCD), Bioquell will validate a cycle utilizing log-6 biological indicators (BIs) placed in the return hose to the generator, downstream of the filter bank. The assumption is that if a full log-6 deactivation has been secured on the BI’s then a similar level of deactivation has been achieved on all exposed upstream surfaces.
Technical
A supply valve and camlock connector with dust plug is permanently installed in a suitable location upstream, between the first filter face and the shut off valve.
A return valve and camlock connector with dust cap and a swagelok pressure sensor connector is permanently installed in a suitable location downstream, between the last filter face and shut off valve.
The generator’s supply and return hoses and pressure tube are temporarily connected to the filter housing connectors. The decontamination cycle is set to run at negative pressure and hydrogen peroxide vapor injected upstream of the filter bank.
The hydrogen peroxide vapor is drawn through the filter bank and back to the generator via the return camlock and generator hose. Biological indicators are placed in the return hose to validate a log-6 sporicidal reduction.
On occasions, due to the number and size of filters and their resistance, it may be necessary to add a regenerative blower into the closed loop system to increase the pressure of vapor going through the filters.
Freeze drier
Pharmaceutical companies often use freeze-drying to increase the shelf life of products, such as vaccines and other injectables. By removing the water from the material and sealing the material in a vial, the material can be easily stored, shipped, and later reconstituted to its original form for injection. Another example from the pharmaceutical industry is the use of freeze drying to produce tablets or wafers. The advantage of which is less excipient and a rapidly absorbed and easily administered dosage form.
Our Solutions
Bioquell can bio-decontaminate freeze driers using our rapid, unique hydrogen peroxide vapor generators. HPV decontamination is perfectly suited for freeze driers due to its residue-free nature and its excellent compatibility with materials.
Healthcare vehicles
Bioquell’s HPV technology allows for ease of bio-decontamination of healthcare vehicles such as ambulances and provides a means of rapidly decontaminating vehicles where the internal layout makes them difficult to effectively clean using traditional, manual methods.
Our Solutions
The confined space and cluttered nature of ambulances makes them extremely difficult to clean manually. Further, the nature of moblile emergency response is associated with a significantly increased risk of environmental contamination, and hence a risk of ongoing cross-infection.
Bioquell’s hydrogen peroxide vapor technology allows ambulance services to rapidly and effectively eliminate contamination from their ambulances, thereby reducing the risk of cross-infection in subsequent patients. This can be performed between patients, if the situation so demands, or on a scheduled basis.
Hospital Unit
During outbreaks or clusters, or just for routine refurbishment or cleaning, entire hospital units can be closed. Bioquell gives the hospital the facility to rapidly and safely decontaminate these units in their entirety, eliminating pathogens and allowing re-admission into a unit free from environmental risk.
Our Solutions
Where units are closed due to outbreaks, hospitals require the facility to fully decontaminate the area before patients can be admitted. Bioquell’s Professional Services teams offer hospitals the ability to eliminate pathogens, in a way that manual cleaning cannot, from these areas overnight using our HPV technology. This service has been shown to be useful in suppressing outbreaks by Infection Control Guidelines and peer reviewed research. The unit decontamination service has also been used extensively during planned refurbishment programs.
FAQs
How is the Bioquell Q-10 different to previous offerings?
Bioquell primarily offered a service in the past. The Bioquell Q-10 suite is the first product designed specifically so hospitals can purchase and operate the equipment. Bioquell has partnered with healthcare workers to produce a system incorporating rapid cycles, increased user efficiency and excellent value.
Can’t we achieve the same result by cleaning?
Cleaning is an essential part of infection control, which can be greatly improved upon by the Bioquell system. Taking C. difficile as an example, 25% of surfaces were found to be contaminated after bleach cleaning1. Bioquell hydrogen peroxide vapor technology effectively eliminates surface environmental contamination (e.g. MRSA, VRE, C. difficile, Acinetobacter) resulting in reduced HCAI risk for subsequent room occupants.
Will it block rooms?
Rooms are completed in approximately 2 hours*, the quickest, proven, room sterilization technology on the market. The Department of Health's SHP report stated that “83% of NHS workers indicated that the Bioquell process caused no delay to discharges or admissions.”
How does the use of this technology impact on hospital accreditation?
Use of Bioquell’s technology is a demonstration that the hospital is committed to providing the safest possible patient environment. Bioquell research, together with the data produced by our Quality Assurance Data system, can be used to demonstrate best practice.
How does it work with housekeeping?
Bioquell negates the need for terminal cleaning with bleach and sterilizes all available surfaces and equipment in hospital rooms. Issues related to staff exposure to cleaning agents are negated by the use of Bioquell’s system.
Are there other systems out there which do the same?
No other whole room bio-decontamination system has shown reductions in infection rates. This is unsurprising as published literature clearly demonstrates the effectiveness of Bioquell’s HPV technology1,2. Bioquell achieves a 6-log spore reduction in approximately 2 hours* – no other system can match this. Further, some other systems have been shown to present Health and Safety risks.
Does it have an effect on infection rates?
Yes. Published data shows that a 53% reduction in C. difficile was associated with a long term Bioquell deployment1, and VRE acquisition risk has been shown to be greatly reduced3. In one study C. difficile rates appear to strongly correlate with periods when Bioquell was used most4.
Isn’t it expensive?
Cost-benefit analysis performed after a Bioquell intervention showed that there were 5.8 fewer C. difficile cases in the months where Bioquell was deployed5. Using published costs6 for C. difficile the projected cost-benefit was over 300% of the investment value.
Will it get in the way of patient care?
The DoH SHP investigated the impact of the Bioquell deployment on patient care and found that “94% of patients were not inconvenienced” - in fact 74% of patients were “unaware that the disinfection was taking place.”
Isn’t a partial surface sterilization good enough?
Put simply, the presence of a pathogen in any quantity on a surface may represent a risk for transmission, which is reflected by proposed hygiene standards7. Further, using
technologies that achieve partial kill allows pathogens with resistance to the chosen method of sterilization to thrive.
Aren’t rates coming down?
Although there has been recent success nationally and internationally in reducing infection rates, most experts would agree that considerably more can be done to reduce MRSA, C. difficile and other infections. Improvements in hand hygiene have undoubtedly helped to reduce infection rates, but experts now consider a “bundled” approach, including environmental interventions, to be the best strategy in reducing nosocomial infection, perhaps even to zero!
Can Bioquell’s technology sterilize soft fabrics or are you restricted to hard surfaces?
Due to the vaporous nature of the system, the technology is able to achieve some penetration into fabrics and soft furnishings.
Will the system damage my electronics?
Bioquell’s technology has been extensively tested against materials typically found in hospitals, and has demonstrated excellent materials compatibility characteristics. As well as 10 years’ use in the pharmaceutical industry, Bioquell has now been used for over five years in hospitals.
References:
1/ Boyce et al. Impact of hydrogen peroxide vapor room decontamination on Clostridium difficile environmental contamination and transmission in a healthcare setting. Infect Control Hosp Epidemiol 2008; 29:723-729.
2/ French et al. Tackling contamination of the hospital environment by methicillin-resistant Staphylococcus aureus (MRSA): a comparison between conventional terminal cleaning and hydrogen peroxide vapour decontamination. J Hosp Infect 2004; 57:31-37.
3/ Passaretti et al. Adherence to Hydrogen Peroxide Vapor (HPV) decontamination reduces VRE acquisition in high-risk units. 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the Infectious Diseases Society of America (IDSA). Washington DC, USA, 2008. Abstract K4124b.
4/ Otter et al. Feasibility of routinely using hydrogen peroxide vapor to decontaminate rooms in a busy United States hospital. Infect Control Hosp Epidemiol 2009; 30: 574-577.
5/ Cooper T and O’Leary M. Clinical impact and cost-benefit of routine, preventative HPV bio decontamination in a UK hospital. Infection Prevention Society, 2009.
6/ Wilcox et al. Financial burden of hospital-acquired Clostridium difficile infection. J Hosp Infect. 1996; 34:23-30.
7/ Dancer SJ. How do we assess hospital cleaning? A proposal for microbiological standards for surface hygiene in hospitals. J Hosp Infect 2004; 56: 10-15.
Incubators
Many customers have a requirement to decontaminate their laboratory scale incubators on a periodic basis or following research change or accidental spillage.
It may also be necessary to decontaminate an incubator prior to a service visit. Whilst it is possible to obtain a reasonable level of sterility by manual cleaning, this does not address the problems of airborne contamination entering the incubator air paths via the recirculation fan.
Most incubators have internally circulated airflow via hidden air ducts to ensure that the incubator temperature is uniform throughout the enclosure.
Using hydrogen peroxide vapor for decontamination of the internal surfaces allows the internal recirculation fan to remain in operation during the decontamination cycle which ensures even distribution of the vapor throughout the chamber and through any hidden air ducts, thereby ensuring effective decontamination of all areas.
Our Solutions
Bioquell HPV gas generators operate over a wide temperature and humidity range which allows many incubators to be decontaminated using HPV without the need for extensive cooling or dehumidification before the cycle starts. Vapor supply and return can be via a temporary front door or by use of Bioquell’s unique dual flow adaptor which allows vapor supply and return via a single 1” service port which is common on many incubator models.
FAQs
Do I need to remove all shelves before decontamination?
No, all shelves can remain in place ensuring that the shelves also get decontaminated along with the other internal surfaces.
How do I remove the vapor from the incubator after decontamination?
The Bioquell L-2 HPV generator will remove all the vapor at the end of the cycle.
I have a large walk in incubator, can that be decontaminated in the same way as laboratory incubators?
Generally yes, but Bioquell should be consulted about the most efficient method of decontaminating large incubators.
Isolators
A barrier isolator, or simply an isolator, is a device that provides a physical barrier between a laboratory technician and a work process.
Isolators are routinely found within the pharmaceutical industry, and with the recent implementation of USP 797 and other similar regulatory standards around the world, are increasingly used in pharmacy applications.
They are designed to provide an isolation of a process or the maintenance of an internal condition (e.g., sterile or aseptic). Isolators may operate at positive, negative, or ambient differential pressure.
Isolators may provide personnel, product, or environmental protection, or any combination thereof. They are used throughout industry, from orange juice filling lines to cytotoxic drug compounding to electronics manufacturing.
Regarding pharmacy applications, because people are the greatest source of contamination during aseptic manufacturing of drugs, reducing personnel interventions into the process zone has significant impact on the efficacy of the final drug product.
Our Solutions
The scientific process and high level 6-log sporicidal efficacy of the Bioquell hydrogen peroxide vapor (HPV) decontamination process makes it ideal for isolator decontamination applications.
Supported by proven validation rationale and documented GMP/cGMP compliance optimized cycles can be developed across different scales of process application.
From a range of Bioquell HPV generators, using direct injection techniques for optimized control, applications may include
- Sterility / Bioburden testing
- Compounding
- Aseptic transfers (loading/unload Freeze Dyers, Autoclaves), aseptic assembly of medical devices and Aseptic Fill-finishing.
Decontamination processes are fully automated with integrated gas distribution and control. Together with one of Bioquell's Rapid decontamination transfer solutions fully optimized cycle times can be achieved leading to reduced downtime and improved process efficiency.
FAQs
Can the vapor be injected through the isolator EPA filters?
While it is theoretically possible to inject the vapor through the isolator HEPA filters this will result in long decontamination cycles. Direct vapor injection provides improved process control and reduced cycle times.
Can the HPV generator control system be integrated with the isolator control system?
Yes, all Bioquell HPV generators utilize the latest PLC control systems which can be fully integrated with the isolator control system. When correctly integrated, improved cycle times and increased safety can be achieved. Consult Bioquell for integration details.
Can the isolator transfer hatches be decontaminated independent of the main chamber?
Yes, if the isolator is configured correctly then transfer chambers can be decontaminated independently or in conjunction with the main chamber.
IVC
IVC’s can be decontaminated individually using relevant connection accessories and a hosed type generator (Bioquell L-2 or Bioquell C) or as part of a full room and equipment decontamination.
Our Solutions
Hydrogen peroxide vapor is ideal for providing a safe and effective method of decontaminating IVC ventilators, where the internal parts are heat sensitive and inaccessible to traditional cleaning methods.
FAQs
Can I use hydrogen peroxide vapor to decontaminate my cages as well?
Traditionally, cages are decontaminated using autoclaves or cage washers. In many cases, it is possible to decontaminate the ventilator, rack and cages as a single unit – however some cage materials may absorb hydrogen peroxide thus leading to increased cycle times.
Technical
IVC’s individually decontaminated
Typically, the cages are removed from the IVC system for decontamination via an autoclave or cage washing system. The Bioquell L-2 or Bioquell C is positioned close to the individual ventilator. Depending upon the IVC configuration, typically the generator supply hose is coupled via the air intake on the ventilator system whilst the generator return hose is coupled via the air outlet. An additional bypass hose is utilised to close the loop between the rack air supply and the rack air return.
Hydrogen peroxide vapor is injected into the IVC and drawn through the system and back to the generator in a loop. Biological indicators are placed in the return hose to validate a log-6 sporicidal reduction.
Room & IVC decontamination
Typically, the cages are removed from the IVC system for decontamination via an autoclave or cage washing system. The disconnected ventilator system is set to run inside a sealed room that is to be decontaminated by a Bioquell generator. Where possible, Log-6 biological indicators would be positioned in a suitable place inside the filters to validate the cycle. The generator is set to run its decontamination cycle and hydrogen peroxide vapor is continually drawn from the room through the ventilator to secure full decontamination.
Material transfer
Material transfer into Class A environments is one of the most common causes of aseptic processing failure.
Keeping an aseptic process supplied with components and materials requires numerous operator interventions that present a contamination risk.
Traditional wipe-down procedures are subjective and, hence, are difficult to validate. Transfers of this type rely on quality operator training and accurate execution of standard operating procedures (SOPs).
Regulation is supporting the use or validatable, automatic robust transfer technology that reduces the risk of contamination from multiple material transfers into the Class A environment.
Our Solutions
Manual disinfection of materials entering or exiting controlled areas does not provide effective and robust surface decontamination and can lead to transfer of bio-contamination. To eliminate such risk the use of HPV gassed transfers has increased. Bioquell has developed a range of material transfer solutions to meet requirements of scale and speed of transfer time. Cycle times with 6-log sporicidal reduction of smaller transfer systems can be as low as 15 minutes. Larger scale Walk-in Transfer times can be as low as 1 hour.
Key features of the Transfer Chamber designs meet requirement for efficacy, cycle time, safety together with selectable interlock priority so that bio-decontamination can be assured at entry or exit from a controlled area.
Medical equipment
Bioquell’s HPV technology provides a rapid and repeatable way of decontaminating portable medical equipment, especially sensitive electronics, which are often identified as a significant challenge for hospitals.
The bio-decontamination of medical equipment that has been compromized by nosocomial pathogens is of key importance - Bioquell's hydrogen peroxide vapor decontamination system is able to eliminate HAI from all exposed surfaces and high touch sites, without affecting either the performance or aesthetics of the equipment.
Our Solutions
The decontamination of portable medical equipment, especially sensitive electronics, presents a significant issue for hospitals. Not only is the equipment physically difficult to clean, but the responsibility for doing so is often poorly-defined and there is much debate over the efficiency of having clinical staff perform this duty.
To exacerbate matters, there are many cases where bleach cleaning is warranted, but hospitals are understandably unwilling to risk using bleach on sensitive electronics for fear of causing damage.
Bioquell provides a rapid solution for equipment decontamination, providing the facility to decontaminate entire areas full of equipment without any deleterious effects.
FAQs
Have manufacturers approved the use of Bioquell with their equipment?
Unfortunately, this research has not been done; however, Bioquell has now decontaminated over 60,000 hospital rooms, most of which contain sensitive electronic equipment with no deleterious effects. Further, each Bioquell cycle exposes the Siemens electronics platform upon which the system is based, to the decontamination process, and there have been no issues of degredation.
Medical supplies
Bioquell’s HPV bio-decontamination technology is able to generate cost-savings by decontaminating the outside of unopened consumable supplies (eg syringes), thereby negating the requirement to discard them after the discharge of an infected patient.
Medical supplies can be left in situ, whilst the bio-decontamination process is taking place in the compromized room / area.
Our Solutions
Many hospitals have a policy of decontaminating unopened medical supplies which have been stored in the room of a patient on precautions for ‘high-risk’ pathogens (eg Acinetobacter, type 027 C.difficile).
Although most hospitals attempt to store the majority of supplies outside patient rooms, this is not possible in areas such as Intensive Care Units, where rapid access to the supplies is necessary.
By laying the supplies on a wire trolley and exposing them to a decontamination cycle, Bioquell’s hydrogen peroxide vapor bio-decontamination technology is able to rapidly and effectively decontaminate the outside of the packaging, thereby negating the need to dispose of the consumables and potentially generating significant cost savings.
FAQs
Will moisture breach the integrity of the packaging?
The Bioquell process relies on micro-condensation (<5 microns) and there is therefore no ‘wetness’.
Operating Rooms
Bioquell is able to effectively and repeatably decontaminate operating rooms after high-risk patients or during maintenance and refurbishment programmes. Our patented hydrogen peroxide vapor bio-decontamination solution is rapid, leaves no residues and ensures complete peace of mind.
The effective bio-decontamination of areas which are high risk is of specific importance - Bioquell's process is proven to eliminate problematic HAI from the operating theatre environment.
Our Solutions
During refurbishment, maintenance or where infected patients have been operated on, the hospital requires an effective, repeatable method of decontaminating operating theatres. Bioquell’s Professional Services can be deployed in an emergency or scheduled scenario to totally eliminate pathogens from the environment, thereby allowing the theatre to re-open with the certainty the everything has been done to limit ongoing environmental risk.
FAQs
Have manufacturers approved the use of Bioquell with their equipment?
Unfortunately, this research has not been done; however, Bioquell has now decontaminated over 60,000 hospital rooms, most of which contain sensitive electronic equipment with no deleterious effects. Further, each Bioquell cycle exposes the Siemens electronics platform upon which the system is based, to the decontamination process, and there have been no issues of degredation.
Can you operate in a sensitive environment?
Yes, Bioquell engineers have extensive experience in operating with care and discretion in sensitive hospital environments?
How long does a room take?
This will depend on the size of the room. Typically, a one bed room with no bathroom takes approximately 90 minutes to decontaminate. For a two bed room, this is extended to just over two hours.
Do we need to clean before Bioquelling?
Yes, a standard clean (to remove gross contamination) should be performed prior to the Bioquell process.
Process Equipment
Where equipment is used in an environment whereby contamination must be minimalized/nil, Bioquell's HPV process can be deployed to manage/eradicate this contamination risk.
Our Solutions
Process equipment applications are increasing with either the need to manage bio-contamination e.g. Incubators or prepare surfaces of equipment in preparation for sterile or aseptic processes.
The acceptance that the gaseous vapor phase decontamination process can be validated to achieve conditions of surface sterilization has opened this application to freeze dryer decontamination. Bioquell have developed a freeze dryer decontamination solution to meet this requirement.
There has also been a requirement to develop a HPV ‘cool cycle’ for autoclaves where the autoclave is used as a material transfer chamber for heat and vacuum sensitive materials or equipment e.g. computer, keyboard decontamination etc.
RABs
The restricted-access barrier system (RABS) can be an alternative to isolators and clean rooms. The RABS concept entails a physical barrier between operators and production areas, but the barrier is limited.
The level of contamination control lies somewhere on the spectrum between a conventional clean room aseptic process and an isolator process. A limited barrier is acceptable because RABS always must be set up in high-class clean rooms (at least ISO 7).
RABS provide product protection and contamination control by a combination of a ‘physical and aerodynamic barrier’ over the critical process zone. RABS offer the advantage of easier access to the process in the event that an intervention is required.
The extent of separation of the process and the surrounding environment, including the most potentially contaminating sources, people, set a scale of product protection and risk reduction of contamination during processing and in process transfers.
Our Solutions
Bioquell have led the development in closed design RABS decontamination with a gaseous vapor phase process. Gassed RABS mitigate risk from aseptic assembly of out-of-place sterilized parts using a gassing-in-place (GIP) process for surface sterilization of in-direct product contact parts e.g. feeder bowls. Optimized management of the condensable hydrogen peroxide vapor by maintaining the necessary 2-6 micron sub-visible micro-condensate yields optimium cycle times. For example a 30m3 filling line with a closed design RABS was validated with a 3 hour cycle time.
Open Design RABS which cannot be closed for gaseous Vapor phase decontamination can use one of Bioquell's room decontamination systems so both RABS and cleanroom can be decontaminated together. An example from one project demonstrated a 4 hour validated cycle for the filling room, open RABS filling line with freeze dryer (Lyo) loading section (with pass through) to capper room. RABS barrier doors remained closed in the combined cycle with 6-log sporicidal efficacy achieved in the cleanroom and RABS barrier so indirect contact parts were also gassed-in-place and surface sterilized.
Rack washer
In an ideal world it would be preferable to install a rack washer, autoclave and decontamination chamber on the boundary of a clean room or research facility however, in facilities where space is restricted it can be possible to configure a rack washer to act as a decontamination chamber during quiet periods when the usual wet process is not in operation.
Many facilities find it advantageous to have a means of decontamination which does not involve high temperature or wet process stages and hydrogen peroxide vapor is widely accepted as the best solution due to it’s broad spectrum efficacy and excellent material compatibility making it suitable for many decontamination applications, including electronic equipment.
Our Solutions
Working in partnership with many of the worlds leading suppliers of rack washers, Bioquell can integrate the gas generator control system with that of the rack washer to provide an efficacious decontamination system which is easy to operate and ensures that all safety implications are considered so that the integrated process presents no risk to operators or other personnel.
FAQs
Can any rack washer be used as a decontamination chamber?
Only rack washers which can be pumped almost dry can be used. Washers with the reservoir in the bottom of the chamber cannot be used as a decontamination chamber.
Can existing rack washers be converted to decontamination chambers?
In general, as long as the chamber can be pumped almost dry it can be converted to a decontamination chamber. If in doubt consult Bioquell.
Are there any special requirements for the rack washer?
Temperature and humidity are key to developing an effective gassing cycle.
How will I know that the decontamination process has worked?
Bioquell will develop a cycle using a known biological challenge and program this cycle into the gas generator.
Robotic enclosures
Robotic enclosures are complex structures housing airflow equipment, operational robots and incubators. Manual decontamination of the robotic equipment is challenged due to the complexity of the equipment which presents difficulties for operators to access all areas requiring cleaning.
The enclosures themselves are likely to have multiple openings in the structure to allow controlled airflow throughout the system and these need to be sealed to allow a safe and efficacious gassing cycle to take place.
Automated cell culture systems for multiple cell-lines and assay-ready plate production are used in busier laboratories to improve quality and productivity and to eliminate the manual process carried out in biological safety cabinets.
In common with biological safety cabinets these robotic enclosures, and the integrated incubators, should be decontaminated on a regular basis and should certainly be decontaminated before being worked on by service engineers.
Our Solutions
Bioquell can offer a variety of solutions for decontamination of robotic enclosures including supply of equipment for customers to carry out their own decontaminations using pre-validated cycles and a service decontamination carried out by Bioquell trained technicians who will visit the customers site as required and use small portable generators from Bioquell’s service stock.
FAQs
Can any robotic enclosure be decontaminated using HPV?
As long as the enclosure can be sealed from the room environment then HPV can be used for decontamination.
Who is responsible for sealing the enclosure?
If the customer purchases their own gas generator then they will be responsible for sealing the enclosure. If Bioquell’s service is used the the Bioquell Technicians will seal the enclosure.
Room/facility bio-decontamination
In many applications, such as clean rooms, research laboratories and high containment laboratories there will be a requirement to decontaminate to maintain aseptic conditions or to restore safe conditions following an incident in a containment laboratory.
Rooms can be decontaminated with hydrogen peroxide vapor using either a fixed system, semi-permanent system or fully mobile system depending upon the application.
Our Solutions
Bioquell have a wide range of gas generators suitable for decontamination of rooms and can offer the most appropriate solution tailored to meet the needs of individual customers. We can work with end users for decontamination of existing facilities or work with consultants and building contractors to incorporate a decontamination solution into a new facility during construction.
FAQs
Can I still gas a room if I can’t control the room ventilation system?
The room ventilation system needs to be isolated during the gassing process. If isolation dampers are not accessible then the ventilation grills can be blanked off.
If I blank off the ventilation grills how will I remove the vapor after decontamination?
Bioquell gas generators have built in catalytic filters to remove the vapor and additional catalytic filters can be supplied if a faster cycle is required.
Will computer equipment and electronic equipment be damaged by repeat exposure to hydrogen peroxide vapor during a bio decontamination cycle?
Bioquell have performed extensive testing with sensitive electronic equipment and tests have shown that there is no damage, or degradation in performance, as a result of HPV decontamination. In fact HPV is effective at decontaminating this type equipment which is not normally possible to decontaminate using other decontamination processes.
Is hydrogen peroxide bio-decontamination effective against TB organisms?
Published evidence suggests that Bioquell’s HPV process is able to inactivate Mycobacterium tuberculosis.
Can the hydrogen peroxide vapor bio decontamination cycle be validated?
Yes, The process can be fully validated and has successfully been audited by many of the global regulatory authorities. The Bioquell HPV process has been included as the chosen method of contamination control in many high risk pharmaceutical processes due to thorough and robust validation data and a high level of process control.
How long does the bio decontamination cycle take?
The time taken for a Bioquell HPV decontamination process is very much dependant on the volume of the area to be decontaminated, the ambient environmental conditions and the equipment used to deliver the process.
In Bioquell’s rapid transfer PORT a cycle can be as short as 20 minutes but in a large room, a cycle could take a few hours. HPV generating systems are selected best meet the process requirements and desired cycle times.
What are the effects of exposure to hydrogen peroxide vapor?
To be an effective disinfection agent Hydrogen Peroxide has to have detrimental effects on biological systems. Hydrogen peroxide is an irritant of the eyes, mucous membranes, and skin. Inhalation of high concentrations of the vapor or mist may cause extreme irritation of the nose and throat [Hathaway et al. 1991].
The inhalation of 7 ppm causes lung irritation in humans [NLM 1992]. Severe systemic poisoning may cause headache, dizziness, vomiting, diarrhoea, tremors, numbness, convulsions, pulmonary edema, unconsciousness, and shock.
Exposure for a short period of time to the mist or spray may cause stinging and tearing of the eyes [Hathaway et al. 1991]. Splashes of high concentrations of hydrogen peroxide in the eyes may cause severe corneal damage.
At very low concentrations (1 to 3 percent), instillation of hydrogen peroxide into the eye causes severe pain that later subsides [Grant 1986].
In comparison with other disinfection agents Hydrogen Peroxide has higher acceptable exposure limits.
Is hydrogen peroxide vapor visible or does it have an odour?
No, Hydrogen Peroxide vapor is not visible but it is possible to sense the presence of the vapor. Often people claim a “clean smell” and in higher concentrations can sense a tingling in the mucous membranes and eyes
What are the legal exposure limits to hydrogen peroxide vapor?
There is no global standard for exposure limits for Hydrogen Peroxide. The US have the most developed set of exposure limits which can be found in the following link - http://www.osha.gov/SLTC/healthguidelines/hydrogenperoxide/recognition.html
Is it possible to detect the vapor in the atmosphere? How can this be done?
There are a variety of ways of detecting Hydrogen Peroxide. This can be done using Chemical indicators or by using electrochemical sensors. Bioquell use both and can advise on appropriate methods of detection dependant on the applicaton.
Will the cycle/vapor damage my laboratory?
Hydrogen Peroxide vapor has a very favorable material compatibility profile. Bioquell has tested and documented computability testing on a wide variety of materials and this report can de downloaded here. Generally most laboratory equipment, including computer systems, can be left inside the area to be decontaminated and will be decontaminated during the process.
What type of materials are affected by the HPV bio decontamination process?
Bioquell have decontaminated tens of thousands of areas with no detrimental effect on the room construction or the equipment within the room.
These would include rooms occupied by sensitive electronic equipment and computers. Bioquell will survey a site prior to decontamination and are able to identify and advise on any material compatibility concerns.
In summary, materials that naturally oxidize in the ambient environment will suffer accelerated oxidation. Materials such as copper will form an oxidation quicker than they would normally experience in the natural environment.
Some polymeric materials, such as Nylon and natural rubber, are chemically affected by Hydrogen Peroxide and may become brittle after repeated exposure. Synthetic materials such as silicon and PTFE are unaffected.
Older oil based painted surfaces may also be affected by Hydrogen Peroxide as the paint curing process is oxidation based and the hydrogen peroxide oxidation ability may affect the surface.
However, most modern paints are water based and are not affected. Surfaces which have been poorly finished or with a very thin paint covering can allow Hydrogen Peroxide through to the substrate.
If the substrate is susceptible to oxidation then oxygen bubbles can be created under the painted surface. Again, this is unusual as most painted surfaces are of an appropriate quality.
Is hydrogen peroxide vapor able to deal with gross contamination such as in a spillage/emergency situation?
In general an area has to be physically clean prior to a decontamination with Hydrogen Peroxide vapor. The Hydrogen Peroxide vapor has to be able to “see” the contamination in order to de-activate the contaminant. However, to a lesser or greater extent, this is the same for any vapor based decontamination system.
Technical
A fixed system utilizes fixed pipework with the gas generator in a remote location so that the room can be gassed at any time without the need for equipment set up.
This system is most suitable for frequently gassed rooms or high containment laboratories. A semi-permanent system can also be used for high containment laboratories with gassing connections into each laboratory.
The gas generator remains mobile and can be moved from laboratory to laboratory as required. In a fully mobile system the gas generator is placed inside the room to be decontaminated and operated by remote control.
Safety cabinets
A range of suitable and standardized decontamination protocols exist for the decontamination of different types and makes of safety cabinets including both re-circulatory and ducted biological safety cabinets, utilizing either the Bioquell L2 or Bioquell C hydrogen peroxide vapor generators
Bioquell have many years experience in working with biological safety cabinets and can advise on the fastest and most appropriate methods of decontamination.
Hydrogen peroxide vapor has many advantages over alternative methods such as formaldehyde including its speed, safety and the ability of the lab to stay operational during the cabinet decontamination process.
Our Solutions
Hydrogen peroxide vapor is an ideal method for providing a safe and effective method for the decontamination of Biological Safety Cabinets either routinely or prior to servicing or carrying out DOP test on the HEPA filters. Holding the decontamination at negative pressure means that the risk of hydrogen peroxide leakage is minimized thus negating the need to vacate the room during the decontamination process.
FAQs
Will hydrogen peroxide vapor damage my HEPA filters?
Hydrogen peroxide vapor is safe to use with all modern HEPA filters. Mainstream, hydrogen peroxide generators contain HEPA filters that are continually exposed to hydrogen peroxide during the decontamination process with no adverse effect.
Technical
Glossary
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Re-circulatory BSC’s: Typically the generator’s supply hose is connected to a purpose built connector either permanently fixed to the main chamber wall or via a temporary template taped across the front of the main chamber. The return hose is connected either via a connector off the same template for decontaminating just the main chamber or via a connector taped and sealed into place on the BSC extract grill for a full decontamination of chamber and HEPA filters.
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Ducted BSC’s: Typically the generator’s supply hose is connected to either a purpose built connector either permanently fixed to the main chamber wall or via a temporary template taped across the front of the main chamber. The return hose is connected either via connector off the same template for decontaminating just the main chamber or via a purpose built connector permanently installed on the extract duct between the terminal HEPA filter and the damper on the exhaust duct.
A pressure sensor connector is also attached to the Biological Safety Cabinet to allow connection of the generator pressure hose to ensure that the cabinet is kept at negative pressure throughout the decontamination cycle.
Sensitive Equipment and Interior Decontamination
The ability to eradicate biological and chemical warfare agents from key assets, including sensitive equipment and the interior of critical facilities is a problem faced by all military forces.
This can include the decontamination of sensitive equipment and electronics such as night vision goggles, lap top computers, electronics, sensitive weapons systems, avionics and optics which are crucial to ongoing operations.
Our Solutions
Bioquell has developed a range of hydrogen peroxide vapor (HPV) systems for the bio-decontamination of enclosed spaces or equipment in various sectors including defence applications. Bioquells hydrogen peroxide vapor (HPV) technology is used to eradicate biological and chemical warfare agents from key assets, including sensitive equipment and the interior of critical facilities. This can include electronics such as night vision goggles, lap top computers, electronics, sensitive weapons systems, avionics and optics.
Bioquell’s HPV technology has been incorporated into the United States Department of Defense (DoD) Joint Service Sensitive Equipment Decontamination Program (JSSED).
Shelter CBRN Filtration
The protection of military and civilian personnel, together with key assets including sensitive equipment and critical facilities, from potential CBRN hazards is vital.
Shelter CBRN Filtration systems also play a key role in providing rest and relief from the effects of wearing full Individual Protective Equipment (IPE or MOPS).
This is especially important for key facilities such as strategic equipment, field hospitals, command and control centres, medical dressing stations and static logistic support facilities.
Our Solutions
Bioquell Defense offers CBRN filtration systems both for use with rigid / ISO container type shelters and also Unhardened Collective Protection tent style facilities. Our adaptable and versatile Shelter CBRN Filtration solutions can be configured to provide clean filtered air directly into the shelter of via the shelter air conditioning system and can be engineered to suit a variety of airflow and shelter pressure requirements.
Platforms currently utilising Bioquell Defense Shelter CBRN Filtration systems include the Marshall SV DARS and Watchkeeper programmes.
FAQs
How long does a CBRN filter last?
The life of any CBRN filter is dependent upon the concentration of any attack, type of attack, weather conditions and duration of the attack or CBRN threat.
What is the flow rate of the system?
The NATO No1 and US M48 CBRN filters are rated to deliver 170m3/hr (100cfm) of clean filtered air.
Can the Bioquell CBRN system be used for all vehicles?
The Bioquell CBRN system can be configured in a number of different ways so that it can be integrated into a range of different vehicle types from tracked to wheeled.
Can Bioquell provide over pressure systems only?
The system is capable of being adapted to provide over pressure or assisted breathing for crew face masks. It is also capable of being configured to provide a combination of both as necessary.
What cooling capability is available from Bioquell?
The Crew Cooling and Environmental Control Systems provided by Bioquell are configured to suit the customer or end user’s individual requirements and can range from 5 to 10kW as required.
Can the Bioquell Environmental Control System be used for all vehicles?
The Bioquell system uses, where possible, COTS and MOTS parts and can be designed and configured to be integrated into most vehicles.
Single Patient Rooms
Where hospitals are experiencing outbreaks, or simply have rooms they believe present a risk to subsequent patients due to residual contamination, Bioquell’s Professional Services can rapidly decontaminate these hospital rooms using our hydrogen peroxide vapor technology.
Our Solutions
A wide body of research describes the residual risk of HAI presented by admission to a room previously occupied by a patient infected or colonized with a nosocomial pathogen. These infections are associated with poor outcomes and increased length of stay, which is financially damaging to hospitals. By eliminating any residual pathogens, Bioquell’s services reduce HAI infecton rates, improving outcomes, reducing length of stay and offering considerable cost-benefit to the hospital. The service is used frequently to arrest the development of outbreaks, and, further, is now increasingly used where patients who have been admitted with ‘high-risk’ infections (eg MDR-Acinetobacter, KPC-2) are discharged. This gives the hospital peace of mind that everything has been done to reduce the risk of ongoing transmission.
FAQs
What can we leave in the unit/room?
The Bioquell process has excellent materials compatibility characteristics. Bioquell is fully compatible with sensitive electronics, and most hospitals actually view Bioquell cycles as an opportunity have mobile equipment decontaminated. Any IV drips should be removed. You should consult with the Bioquell sales specialist with regard to any specific requests.
Are there any residues?
No, the Hydrogen Peroxide Vapor (HPV) is catalytically converted to water vapor and oxygen after the decontamination is complete, allowing the hospital to immediately admit new patients.
What would happen if someone entered the room or there was a leak?
Bioquell’s standard operating procedures have been fully risk analyzed and have allowed engineers to safely decontaminate over 60,000 rooms with no reportable incidents. Rooms are sealed and signed during the process and an engineer is in attendance during the vapor generation phase of the cycle to ensure that no one enters the room. Further, the system has been designed so that once the cycle is aborted, the levels of peroxide will quickly drop below the Immediately Damaging to Life and Health (IDLH) limit of 75ppm. If someone were to enter the room, they would experience severe respiratory and ocular irritation and would leave the room quickly. Engineers check for any leaks during the cycle using a highly sensitive hand-held electro-chemical sensor. If a leak is detected that is likely to increase the environmental level of Hydrogen Peroxide Vapor to >1ppm (the Long Term Exposure Limit) then the cycle is immediately aborted.
Do we need to clean before Bioquelling?
Yes, a standard clean (to remove gross contamination) should be performed prior to the Bioquell process.
What is the maximum size room we can Bioquell?
We can decontaminate any area, as our Service HPV generators can be networked to ensure even vapor distribution throughout any area.
How long does a room take?
This will depend on the size of the room. Typically, a one bed room with no bathroom takes approximately 90 minutes to decontaminate. For a two bed room, this is extended to just over two hours.
Sterility testing
Sterility testing is required during the sterilization validation process, as well as for routine quality control and detecting major contamination in a batch. The test environment should be as stringently controlled as an aseptic processing environment. Sterility testing is an extremely difficult process that must be designed to eliminate false positive results. False positive results are generally due to laboratory contamination from the testing environment or technician error.
Bioquell has over 10 years experience in providing integrated solutions for sterility testing. Our latest product, the Bioquell QUBE is an aseptic work station equipped with appropriate environmental monitoring systems, sterility test system and Bioquell’s unique hydrogen peroxide vapor (HPV) decontamination technology.
This ensures that an aseptic environment is maintained and material movements in, and out, of the aseptic work zone are efficient and do not compromise the aseptic environment.
Often it is the end user who is required to integrate the all components required to create a complete sterility test solution. Bioquell expertise in aseptic process allow us to work alongside the end user to select the most appropriate components and integrate into a complete sterility test solution.
Our Solutions
To meet the challenges of sterility testing, Bioquell has developed a revolutionary new fully integrated hydrogen peroxide vapor (HPV) solution. The Bioquell QUBE offers a rapid sporicidal bio-decontamination process with a high level validated 6-log reduction in bioburden. This bio-decontamination system has been designed to complement a fully fitted and validated sterility test unit such as the market leading Millipore Steritest system.
Designed to act as a modular, barrier separation technology (‘closed system’), the Bioquell QUBE provides a physical separation of operators to the sterility test process. The intelligent modular design principles give users flexibility in selecting the most suitable configuration for their individual process. This allows users to build the Bioquell QUBE system to their process requirements (e.g. a single module if space is at a premium, up to a full 3 workstation units for high volume throughput). The closed barrier technology also enables the user to apply automated HPV biological decontamination. Within a single module, a rapid 20 minute bio-decontamination cycle* allows fast and efficient material transfers. The built-in flexible gassing options also allow the user to bio-decontaminate multiple interfaced Bioquell QUBE modules or separately bio-decontaminate test material and samples as part of a rapid gassing transfer process. To help ensure users can maximize working area while maintaining aseptic conditions, samples and waste removal can be made via a transfer hatch or rapid gassing port.
* When using a single unit and depends on loading and absorbency of chamber contents.
Vehicle CBRN Filtration
The ability of a vehicle crew to operate safely during a CBRN threat is vital. It is also key that any solution used to provide protection from the CBRN threat still allows the crew to continue to operate effectively and efficiently.
The Bioquell Defense vehicle CBRN filtration system allows for an airflow system that can suit any internal, complex vehicle space configuration.
Current vehicles using Bioquell Defense technology include the Force Protection Cougar, FNSS ACV 300 and M113 and BAE Systems Piranha II, Challenger 2 and CVRT.
Our Solutions
Bioquell Defense offers a range of affordable and reliable low life cycle cost solutions that utilize COTS parts and that can be engineered to suit varying space envelopes and airflow requirements. Our solutions can be configured to provide either full over pressure collective protection or filtered air for assisted breathing for a face mask system. A high level of system reliability, with low maintenance and low initial costs results in minimal logistic support and low life costs.
Current vehicles using Bioquell Defense technology include the Force Protection Cougar, FNSS ACV 300 and M113 and BAE Systems Piranha II, Challenger 2 and CVRT.
FAQs
How long does a CBRN filter last?
The life of any CBRN filter is dependent upon the concentration of any attack, type of attack, weather conditions and duration of the attack or CBRN threat.
What is the flow rate of the system?
The NATO No1 and US M48 CBRN filters are rated to deliver 170m3/hr (100cfm) of clean filtered air.
Can the Bioquell CBRN system be used for all vehicles?
The Bioquell CBRN system can be configured in a number of different ways so that it can be integrated into a range of different vehicle types from tracked to wheeled.
Can Bioquell provide over pressure systems only?
The system is capable of being adapted to provide over pressure or assisted breathing for crew face mask. It is also capable of being configured to provide a combination of both as necessary.
What cooling capability is available from Bioquell?
The Crew Cooling and Environmental Control Systems provided by Bioquell are configured to suit the customer or end user’s individual requirements and can range from 5 to 10kW as required.
Can the Bioquell Environmental Control System be used for all vehicles?
The Bioquell system uses, where possible, COTS and MOTS parts and can be designed and configured to be integrated into most vehicles.
Vehicle Environmental Control
To maximize the operational capability of any vehicle and its crew it is essential to provide a reliable and efficient environmental control system.
This is especially true when taking into account the harsh operating conditions that the modern day armed forces find themselves in. It is essential therefore that the working environment of the vehicle crew is able to be controlled effectively and efficiently.
Our Solutions
Designed using existing standard Bioquell Defense technology combined with COTS parts, our systems provide extremely efficient, affordable and reliable low life cycle cost environmental control. A range of ventilation systems incorporate 5kW – 9 kW of cooling as required, together with heating which can be either stand alone or integrated within the Environmental Control System. Our systems can also easily be adapted to provide bespoke solutions to achieve most performance requirements and interface configurations.
Vehicles currently utilizing Bioquell Defense Environmental Control Systems include UK MoD CVR(T), BAE Systems Piranha II, FNSS ACV 300 / 350 and M113 and General Dynamics M3 Amphibious Bridge Layer.
FAQs
How long does a CBRN filter last?
The life of any CBRN filter is dependent upon the concentration of any attack, type of attack, weather conditions and duration of the attack or CBRN threat.
What is the flow rate of the system?
The NATO No1 and US M48 CBRN filters are rated to deliver 170m3/hr (100cfm) of clean filtered air.
Can the Bioquell CBRN system be used for all vehicles?
The Bioquell CBRN system can be configured in a number of different ways so that it can be integrated into a range of different vehicle types from tracked to wheeled.
Can Bioquell provide over pressure systems only?
The system is capable of being adapted to provide over pressure or assisted breathing for crew face mask. It is also capable of being configured to provide a combination of both as necessary.
What cooling capability is available from Bioquell?
The Crew Cooling and Environmental Control Systems provided by Bioquell are configured to suit the customer or end user’s individual requirements and can range from 5 to 10kW as required.
Can the Bioquell Environmental Control System be used for all vehicles?
The Bioquell system uses, where possible, COTS and MOTS parts and can be designed and configured to be integrated into most vehicles.
- Entire hospital site
- Healthcare vehicles
- Hospital Unit
- Medical equipment
- Medical supplies
- Operating Rooms
- Single Patient Rooms
- Containment
- Filter banks
- Freeze drier
- IVC
- Incubators
- Isolators
- Material transfer
- Process Equipment
- Rack washer
- RABs
- Robotic enclosures
- Room/facility bio-decontamination
- Safety cabinets
- Sterility testing
- Sensitive Equipment and Interior Decontamination
- Shelter CBRN Filtration
- Vehicle CBRN Filtration
- Vehicle Environmental Control
Events
News
Highlights
Bioquell RBDS provides a safe, reliable bio-decontamination solution to help heathcare professionals tackle hospital aquired infections (HAI/HCAI) and stop outbreaks of drug resistant pathogens.
Bioquell L-2
The Bioquell L-2 is an exciting new upgrade to the extremely successful and widely used Bioquell Clarus L HPV generator which has been operating in the field for over 6 years.
Emergency outbreak response
If you want to control a ‘superbug’ outbreak or need to bio-clean rooms after a contamination accident, call us today.
Our emergency response teams will professionally bio-decontaminate your areas, returning them to working capacity.
Highlights
Emergency outbreak response
If you want to control a ‘superbug’ outbreak or need to bio-clean rooms after a contamination accident, call us today.
Our emergency response teams will professionally bio-decontaminate your areas, returning them to working capacity.
Highlights
Bioquell RBDS provides a safe, reliable bio-decontamination solution to help heathcare professionals tackle hospital aquired infections (HAI/HCAI) and stop outbreaks of drug resistant pathogens.
Bioquell L-2
The Bioquell L-2 is an exciting new upgrade to the extremely successful and widely used Bioquell Clarus L HPV generator which has been operating in the field for over 6 years.
Emergency outbreak response
If you want to control a ‘superbug’ outbreak or need to bio-clean rooms after a contamination accident, call us today.
Our emergency response teams will professionally bio-decontaminate your areas, returning them to working capacity.
Highlights
Emergency outbreak response
If you want to control a ‘superbug’ outbreak or need to bio-clean rooms after a contamination accident, call us today.
Our emergency response teams will professionally bio-decontaminate your areas, returning them to working capacity.
Downloads
Causes and effect of false positives and false negatives in sterility testing.
This paper reviews the background to false postitives and false negatives associated with the sterility test process. It explores the potential causes of such results and suggests methods of mitigation. It also includes insight into the role of hydrogen peroxide vapor bio-decontamination technology can have on false positives and false negatives while indicating how this technology can also be used to eliminate them.
Bioquell QUBE - Steritest Workstation
Revolutionary new range of fully integrated HPV solutions for sterility testing
Sterility testing is required during the sterilization validation process, as well as for routine quality control and detecting major contamination in a batch. The test environment should be as stringently controlled as an aseptic processing environment. Sterility testing is an extremely diffi cult process that must be designed to eliminate false positive results. False positive results are generally due to laboratory contamination from the testing environment or technician error.
To meet the challenges of sterility testing, Bioquell has developed a revolutionary new fully integrated hydrogen peroxide vapour (HPV) solution. The Bioquell QUBE offers a rapid sporicidal bio-decontamination process with a high level validated 6-log reduction in bioburden.
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