Setting Up an Ideal ART Laboratory

February 7, 2017

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A complete ART unit comprises not just a well-designed, clean room class, working ART laboratory but also, the accessory facilities like,

1. A reception area manned by a tactful and courteous receptionist, 2.A consultation room for patient counseling and for USG monitoring,

2. A collection room, which ensures patient privacy during sample collection,

3. An insemination room for IUI.

4. And the piece de resistance of any ART clinic, which is of course, the actual ART lab complex itself.

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The Modular ART Lab

The goal of a well-designed ART lab is an environment which fosters good working conditions and ensures air quality which will help achieve excellent IVF outcomes. Thus a lot of thought should be put into the construction and design of an ART lab in order to minimize the risks to the gametes and embryos and to maximize embryologist comfort, efficiency and use of space. Workstations should be positioned in such a manner that it will allow the embryologist to complete a procedure without having to move more than 3m in any direction. This is of course limited by the space available and the number of IVF cycles performed in a given time period.

 

While setting up the IVF lab, the location is of utmost importance. The ART lab should provide a safe, non embryotoxic, stable and pathogen free environment. Thus it should be constructed in an area which is in a relatively less polluted area. Locations adjacent to parking lots, petrol pumps, construction areas etc. should be avoided to limit the adverse embryotoxic effects of pollutants. The ART lab complex should be placed more to the interior of the clinic to help ensure firstly, isolation of the lab from the rest of the clinic environment and secondly, and most importantly, restricted access. This is the main thing which needs to be kept in mind. The lesser the thoroughfare into and out of the lab, the better.

The construction material used for setting up the lab is also an important factor to look into. The primary goal during construction of the laboratory is to avoid the use of materials that will give off embryotoxic gases for an extended period of time following completion of the construction. Choice of flooring is standard i.e. seamless sheet vinyl that has an integral base flashed at least 4 inches up the walls. Where pieces of flooring meet, the seam is sealed. This type of flooring seals out odors from materials used in the subfloor and the base of the walls. Compared to tile flooring, it is easily cleaned and does not allow water to seep under the walls. Walls and celing should be of low odor, washable and non-shedding. Currently, the modular lab setup is the method of choice. It comprises large powder coated steel or aluminium sheets put together to ensure no gaps or sharp edges and this helps when it comes to cleaning. The surfaces are non-shedding and do not give off any embryotoxic gases and are amenable to cleaning by 70% alcohol. The setup is also very quick and easy to setup and dismantle as essentially it is somewhat like a wall within a wall. Because of all these things it is the preferred choice despite the higher cost.

As we enter the ART lab there should firstly be a conduit area which separates the inner lab environment from the external environment. The conduit area can also double up as a storage area for some essential supplies required during the procedure and also an area for washing up prior to the procedure. Then starts the actual ART laboratory complex itself. First is the operating room where the OPU and ET will be done. Exactly adjacent to it is the embryology laboratory. The ambient air inside the lab should be highly sterile. This is achieved by doing two things. Firstly, by maintaining the entire area  under positive pressure. Depending on the space available one can either use a small positive pressure unit place in a separate utility room or a separate AHU that supplies to the ART lab complex. This layout facilitates the desired air pressure differential and thus, isolation of the inner lab environment from the general clinic environment. Also, there should be 16-18 air changes per hour.

Secondly, by the placement of activated carbon filtration units like KODA towers within the laboratory to absorb the VOC’s emitted from electrical equipment, new furniture, plasticware etc.  The semen preparation lab will be a separate isolated unit on its own but still needs to be adjacent to the ART lab to ensure quick transfer of prepared semen samples during IVF procedures.

Regardless of the size of the IVF laboratory or the number of cycles performed per year, there is a certain minimum amount of equipment which is absolutely essential to the functioning of the lab. All IVF laboratories should have at least 2 incubators. An incubator is the heart of any culture lab and thus requires backup. Having two incubators ensures a better workflow wherein one can be used as a working incubator for media incubation and equilibration, dish preparation and one that can be opened frequently during oocyte retrievals and micro-manipulation thus saving the other incubator as a stable culture environment.

In addition to incubators, the IVF lab comprises an embryology workstation in the embryology lab and an Andrology workstation in the Andrology lab. These ensure handling of the gametes and embryos under a sterile environment due to a laminar airflow maintained under HEPA filtration. The laminar air flow cabinets are generally class 100 meaning the HEPA filters prevent dust and other particulates measuring 0.3 microns or more from entering the working environment with as much as 95% efficiency. The embryologist workbench, along with the HEPA filters, comprises a heated stage which helps maintain the gametes and embryos at 37°C. It also has an integrated stereozoom microscope for low magnification visualization of samples which is mostly used in oocyte screening and subsequent gamete and embryo handling. It also should have a digital heating block so that the tubes of follicular fluid coming from the OPU room and any other sterile tubes can be maintained at 37°C.

The andrology workstation will be a similar, smaller sized unit, of course without the integrated stereozoom microscope so that there is room to accommodate a light compound microscope with 10X, 20X, 40X and 100X objectives, and a digital heating block.One more important piece of equipment in relation to Andrology is the centrifuge/spermfuge. It allows us to isolate the most motile activated spermatozoa. Ideally a gadget like the spermfuge is more preferable as it allows us to centrifuge the samples at a set temperature and also allows us to spin the samples by setting the g force and not just rpm.

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ICSI Micromanipulator

 

Next is the ICSI workstation. This will be placed within the embryology lab on a vibration free table. The ICSI workstation comprises an inverted microscope and a set of micromanipulators, one for holding the oocyte and one for injecting a single, live, morphologically normal sperm into the cytoplasm of the mature oocyte.The ICSI workstation can also be upgraded, if in future the lab wishes to upgrade to the use of Laser Assisted Hatching and IMSI.

Thus, a well thought out and meticulously designed ART laboratory, adhering to immaculate air quality standards is the starting point to ensure that the gametes and embryos are kept happy. In turn, first and foremost, the patients, as well as the clinicians and embryologists can rest easy knowing that their embryos are growing in the best environment possible. In short, just as Aristotle has so wisely put it, well begun, is indeed….half done.