IVF Mail - IVF Incubators

IVF Incubators

By: Justme,
16 October 2008


Question:
	Are there any documents which state specific information about what consitutes a CO2 incubator which is validated for embryo incubation. Or is it just clear documentation that your incubator is performing to standard wrt temperature, gas concentration etc.

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Michael L. Reed said on 16 October 2008

"This is an interesting question, pitting regulatory requirements against practical applications. There are so many types of incubators - poultry, cell, microbial - bascially defining an incubator as a machine or unit that can provide a controlled atmosphere and/or temperature.

In my lab, in addition to some older incubators, I have two newer, basic CO2 cell culture incubators that have 510(k) approval for IVF, from ThermoForma. I didn't buy them because of the 510(k) approval - although that's nifty - but becuause they were inexpensive relative to other units, and I've had very good reliability from ThermoForma units.

I also use glass jars with a volume of sterile cell culture water in the bottom (to provide humidity) as mini-incubators that contain the embryos, and for temperature control, the jars sit inside the cell incubators. The gas used to fill my glass jars is totally validated by gas chromatography, by pH trials, and by an independent CO2 detector. By my definition, the jars are incubators, although they do require an outside heat source. I could use a heated chamber/incubator without a gas inlet, however I like being able to put other things on the shelf, under the CO2/air atmopshere.

Other chamber types, sealed plastic bags, or bags of other materials, have been used in the same way.

Getting down to it, there are not too many items that are in use in the human IVF lab - aside from culture media -that are actually designed for human IVF. Most are borrowed from other applications - or adapted. There is a listing on the FDA website that has 510(k) approved products, and you'll find a few items, but not as many as you would expect.

So the bottom line, in my opinion, you can design and define your system any way you need to, as long as you can verify, and validate that your units meet your standards - or the standards of the industry - and that your standards meet the needs of the proposed purpose - pH, fertilization, cleavage rates, quality developement, pregnancy and other outcome measures.

Mike"