To assure Lab Managers that the environment they are working in is not negatively impacting their success rates, A21Architects will build-in quality control processes from the design stage to ensure the specific performance requirements for IVF Laboratories are met. At A21Architects we understand that robust quality control systems and attention to detail are essential components for the successful construction of In Vitro Fertilization (IVF) or ART laboratories.
This article will highlight some of the essential performance requirements for IVF laboratory design that should be taken into account during the initial design coordination phases. It will also detail some of the methods employed by A21Architects to ensure the successful implementation of these requirements. Additionally, a downloadable link to an IVF Laboratory Design Checklist we have developed is included at the conclusion of this article.
Isometric view of an A21Architects designed IVF Laboratory Proposal
Gametes and embryos are highly sensitive to environmental contaminants, necessitating stringent air quality and environmental control measures in laboratories. The primary concerns include particulate matter, volatile organic compounds (VOCs), microorganisms, and perfumes, all of which can potentially harm these delicate biological materials. To address these challenges, laboratories must implement robust air filtration systems capable of effectively removing these. The air filtration systems should be designed to ISO 7 air quality standards and provide 10-15 air changes per hour. Ongoing performance monitoring is essential to ensure the continued efficacy of the air filtration system.
Laboratories should maintain a positive pressure environment with a cascading pressure design, carefully coordinated with the architectural layout. Temperature and humidity control are vital, as is the implementation of stringent infection control protocols within the cleanroom laboratory. The mechanical engineer will need to design the air handling system in close collaboration with the architect so the coordinated design makes best use of the available space while effectively maintaining the key Laboratory design principles..
Safety measures and backup systems are critical components of laboratory design. Uninterrupted Power Supply (UPS) systems, generator backup plans, and HVAC backup systems must be in place to protect samples during power failures. Procedures for moving samples to a safe environment in such events should be established. It's important to note that the HVAC system in these laboratories must run continuously, not just during working hours. This constant operation may have potential acoustic impacts on neighboring properties, an issue that needs to be addressed at the site selection and planning stages.
When planning the construction of an In Vitro Fertilization (IVF) laboratory, it is recommended to conduct a comprehensive investigation of VOCs both within the proposed building and its immediate surroundings. This assessment should focus on environmental pollutants, including volatile organic compounds (VOCs) and other particulate and chemical pollution. Key considerations in this evaluation process include the proximity to potential sources such as parking garages, dry cleaners, or any chemical processing facilities. Consultation with local environmental agencies regarding particulate matter data is essential, as is the analysis of PM5 and PM10 concentrations.
This assessment should focus on specific VOCs over time rather than total VOC measurements, recognizing the limitations of snapshot testing and using multiple testing periods to account for potential variations in VOC levels. By thoroughly evaluating these factors, the project proposals can ensure that the chosen site provides the best possible environment for successful IVF procedures. If significant pollution sources are identified, designers can incorporate additional measures that may be necessary to mitigate their impact on the laboratory environment.
View of Nurse Station in Recovery Room At King's Fertility
Each IVF laboratory has its own unique approaches and this will influence the ultimate size and layout of the laboratory space. Over the years, A21Architects has collaborated with numerous IVF laboratory professionals to develop various designs, carefully balancing often competing requirements to create optimal laboratory layouts. This process involves understanding each lab's specific needs and finding opportunities to maximize the use of the available site.
A successful IVF laboratory requires careful consideration of layout and workflow, particularly regarding the adjacencies of different rooms. As IVF laboratory technology evolves, A21Architects has observed that layout requirements have changed and differ with each facility. Therefore, close collaboration with Lab Managers is essential in this process.
Proposals must factor in space requirements for various functions, including staff welfare areas, changing rooms, delivery areas, reception, and storage for consumables. All these elements need to be integrated to match the organization's desired processes. The architect should conduct regular meetings and present layout options to facilitate discussions on optimizing proximity between different areas. These areas may include medical gas storage, operating/procedure rooms, Andrology, Embryology, and Cryobank, Administration, as well as consumer-facing areas of the facility. Furthermore, the potential for future laboratory expansion is often a desirable feature, allowing the facility to ramp up production as needed.
Embryology Lab prior to equipment being installed at King's Fertility
Due to the extreme sensitivity of embryos to volatile organic compounds (VOCs), which are contained in many construction materials, material selection is a crucial aspect of IVF laboratory design. This requires careful attention from the architect to ensure proper specifications are created and communicated. Construction materials can vary widely, and contractors often face a vast array of choices. What they ultimately use may depend on what is available from suppliers on any given day. Therefore, it is crucial to emphasize the importance of material selection, implement robust quality control procedures, and ensure they are consistently followed.
Having a detailed architects specification and ensuring this is accurately followed is therefore key. VOCs can originate from various sources, sometimes in unexpected ways, for instance, while a material itself may be VOC-free, the adhesive used to fix or seal it may not be. This necessitates careful consideration of all components, including wall construction, floor finishes, ceilings, windows, sealants and fixtures. The mechanical engineer's proposals must also take these factors into account. Materials used for ductwork sealing, as well as lubricating residues from manufacturing processes or corrosion prevention treatments, can all contribute to VOC contamination. Consequently, mechanical engineers also need to make provisions in their specifications to mitigate these risks. Bespoke furniture presents a particular challenge, as formaldehyde-rich medium-density fiberboard (MDF) is often used. This requires detailed architects designs for joiners that may be outside their usual production comfort zones. During construction A21Architects generally recommends implementing regular twice weekly inspections of key areas to verify that no offending materials are present on-site and that quality control procedures are being strictly adhered to.
For the positive air pressure system, the specification for sealing the room to achieve the required air tightness performance varies depending on the construction of the existing or new building. A21Architects will specify this so it can integrate with the existing using known materials. Special consideration must also be given to the detailed integration of various room components such as false ceiling system, light fittings, electrical, medical, and HVAC conduits, door design, and pass-through hatches to avoid undesirable air flows, ensure correct construction materials and prevent dust traps. The design and integration of all these elements have the potential to negatively impact performance, therefore, they need to be carefully designed, detailed and specified by the architect to maintain the principles of the controlled environment. Other considerations will include treating the glass windows to adequately reduce UV wavelengths. Plumbing and fire suppression systems need to be carefully considered so as not to introduce unexpected consequences that may put the lab work at undue risk. Coordinating the design with a good fire engineer to eliminate undesirable fire suppression systems may be beneficial.
At completion of the construction works commissioning the Lab will require a process of “Burn In” combined with a “deep clean” of the new laboratory. Burn in gives adequate time for off-gassing of construction materials, at this stage verification of this process should be established by specific VOC testing. A newly constructed or renovated laboratory must be subjected to an intensive cleaning before being validated for clinical use. Every surface, including hard-to-reach corners, inside cupboards and drawers, and all equipment, is cleaned with products capable of removing all expected contaminants, and then cleaned again to ensure no trace of the cleaning agents remains.
Much of the servicing and maintenance regimes to maintain performance will be dictated by the mechanical air handling equipment supplier so ensuring an complete Operation & Maintenance manual is supplied by the contractor is essential. Infection control in a hospital environment will likely have specific requirements and may use chemicals unsuitable for an IVF environment, so the IVF lab will need to develop its own specialist cleaning regime based on the materials used in the laboratory.
The technical requirements of an IVF laboratory are highly specific and often exceed the standard quality control measures typically found on construction sites. Contractors need to be thoroughly informed about the unique demands of IVF laboratory construction, especially in comparison to other medical and laboratory facilities they may be familiar with. It is essential to communicate these unusual requirements to the contractor from the very beginning to effectively manage expectations for on-site work.
A21Architects not only designs the spaces and specifies materials for construction but also plays a crucial role in designing the construction process itself. One of the key ways this is accomplished is through the production of a detailed written specification. This formal contract document forms the basis of expected contractor performance and quality control processes, directly influencing the final outcome of the building. It serves as an essential tool in ensuring that performance standards are maintained on-site. An additional requirement that most contractors may not be accustomed to is the robust level of record-keeping for materials used in and around the laboratory spaces. A21Architects demands this level of documentation and assists contractors by providing clear formatting and signed-off checklists as part of our service. This helps contractors to achieve the required level of performance and documentation.
Incorporating IVF laboratory requirements at the early stages of the project is crucial to prevent abortive construction work. Once construction is complete, it becomes extremely difficult to identify offending sources of contamination and laughably cost-prohibitive to construct a control lab to test the each construction variables involved. Therefore, it is imperative to get it right first time. Robust record-keeping is essential to avoid introducing potentially embryotoxic factors into the laboratory environment. By emphasizing these specialized requirements and providing the necessary support, A21Architects ensures that the construction process aligns with the stringent standards required for IVF laboratories, ultimately contributing to the creation of a safe and effective environment for these sensitive medical procedures.
End of Article, for further information Contact A21Architects
Comments