Did you know it costs over $370,000 (unless you can get waivers) just to file an application to sell a new drug for animal use? This isn’t for attorney’s fees, or consultant’s fees, those would be in addition to this. This is just the FDA user fees. And it doesn’t matter if your “new drug” is really a drug or something else like a whole food product, the classification comes from the simple question “Do you intend to market this to specifically address some form of ailment?” If the answer is yes, then it must go through the whole new drug process regardless of what it is.
One thing I forgot to mention is that even though the stuff I bought was used, older, and has been superseded by more recent models, I did some research and the current models of the stuff I bought are *not* any better in terms of capabilities, they just do what they do faster (1-2 seconds instead of 2-5 seconds for the stuff I bought) and have prettier LCD displays. The significant stats, such as how much mass capacity they have and how accurately they measure that mass (these are mostly all digital balances) are the same for the older equipment I bought and current model line equipment. Having said that, I got all this stuff for 5 cents on the dollar compared to new prices of the replacement models today. I got 6 digital scales, one lab shaker, and 9 calibrated weight sets. New prices for all of them would exceed $40,000. I paid $1,500. Auctions fucking rock! I actually don’t need 6 digital balances, nor 9 weight sets. I plan on selling 4 of the balances paired with 4 weight sets on EBay. I’m hoping to get my entire investment back that way, making my two balances and lab shaker free.
No, I’m not talking about EBay type auctions. I’m talking about real, honest to God, people sitting in a room, auctioneer drumming up bids type auctions that you can attend over the Internet. Lots of people (especially ones planning on bidding on lots of stuff and needing to check it out first) go in person. Some people (like me, who only wanted a few items and had a limited budget) attend over the internet. They had this custom app that connected to their server, showed you which item was currently up for bid, allowed you to do real time bids over the internet, and showed you in real time bids they accepted from the floor. It was waaaay cool. In addition, they had a 1-800 number you could dial into and listen to the auctioneer as he did his thing. It was funny to hear him say things like “Internet, are you done? Any more?” and sometimes when no one from the floor was bidding on something and it was just internet bidders he would say something like “Well, I’ll let the internet bidders do their thing until there done. In the mean time, have you guys tried those chicken sandwiches? They’re great!”
Anyway, I attended one of these on Dec. 11th. I won some items. I didn’t want to fly down to retrieve my items since they were in Manati, Puerto Rico, so I hired a rigger to box them up and ship them to me. I asked him to get me tracking numbers. Well, he kept saying he shipped it, but never once gave me a tracking number. After three emails, probably six or so phone calls, and two weeks, he STILL hasn’t gotten me any tracking numbers. However, the shipping company called me this morning to say “Your crate arrived in the port of Miami and is ready to be shipped to your address. Is it a home or business address and do we need to bring a truck with a lift gate?” So, my stuff is finally about to be delivered, and my stress over the fear that this guys just took my money and left my assets at the auction site to be thrown away, given to someone else, whatever have finally been allayed no thanks to the guy I hired and paid $820 to ship my stuff. You would think for $495 packing/handling fee (+$325 for the actual shipping charges for the total of $820 I paid him) he would have been a little more responsive, but I guess not. Am I a sociopath for fantasizing about flying to Puerto Rico and blowing up his car or something like that as revenge for him taking my money and doing nothing (assuming that my stuff never arrived and I gave up hope after a suitable period of time had passed)?
When ice sublimates in a vacuum (that’s the process where by ice goes directly to water vapor without first melting), it requires heat (just like when you sweat and the sweat evaporates, the process of evaporation removes heat thereby cooling your body). This causes the ice to get colder and colder until it’s so much colder than the surrounding environment that the radiant heat being transferred to the ice equals the amount of heat being consumed by the sublimation process. I’ve seen this effect cause the ice in the freeze dryer to go from being about -5′C down to about -45′C. If you can add additional heat via the heating coils, then the ice stays warmer and sublimates faster. I was worried because the lowest setting for the heater thermostats on the freeze dryer is 60′F (about 15′C). I was afraid that the thermostats wouldn’t allow me to set the temp any lower, and that a temp this high would actually add so much heat that it would cause the ice to melt before it sublimated and thereby screw up the freeze drying process. As it turns out, even though 60′F is the first mark on the thermostats, if you don’t turn them all the way up to that first mark, they still work and they will allow you to set the temperature lower than that. They actually go all the way down to about 23′F (or -5′C). So, I set the thermostats to about 40-50′F (6-10′C), which is above freezing, but due to the laws of thermodynamics and heat transfer principles, the shelf can be slightly above freezing and still not transfer enough heat to the ice to cause it to melt. By being able to set the heat to this setting and then just leave the heat turned on all the time (versus going out once an hour to turn the heat on for 5 minutes or so just to rewarm the shelves from -25′C up to about 0′C), I should be able to speed the drying process. I’m hoping to get the total drying time down from roughly 48 hours to 24 hours. If I can, then I both half my costs per batch, and double my annual capacity (assuming the machine is kept running 24/7). This is important because I can only get somewhere around 2,000 to 8,000 pills worth of product per batch, and with a dosage of 3 to 4 pills per day per, that’s not a whole lot of production capacity should this business take off. So, the faster I can run stuff through, the longer we can make do with this freeze dryer before I have to build the custom freeze dryer I’ve been designing in my mind. BTW, when I’m done building that custom freeze dryer, I’m going to name the specific method of freeze drying that it uses the “Ledford Method” of freeze drying. I’m such an egomaniac
Making little ice cubes instead of big ones solved the “Honey, I destroyed another blender” problem. Another round of freeze drying under way, all four shelves in use this time. I would estimate that the machine is at roughly 50-60% capacity. I didn’t have enough to fill it up
So, I replaced the blender of ryeth’s that I destroyed. The base unit was fine, the blades were fine, it was just the polycarbonate blender containers that I tore the holy living hell out of. So, I bought the same unit again, and because we have extra blades and an extra base unit, we were able to effectively come out with two functional blenders (this model comes with three containers and only one base unit). She’s happy, and busy making herself a smoothie in the new blender. I also went back to the store that sold me the two commercial blenders and got the parts to repair the units (plus extra spares in case it happens again). Then I ordered some new ice cube trays online that create little 1/2″ cube ice cubes so that maybe they won’t be so hard on the blenders. That should at least make up for my destructive streak.
I was only running one tray this time. I specifically didn’t add any heat, although I stirred the mixture roughly every two hours. Total time to freeze dry was about 44 hours, including secondary drying. I’m hoping to get the total elapsed time down to 24 hours including secondary drying. Material appeared to be about 2/3 water based upon volume loss in freeze drying. I could probably condense the mixture further before drying and be just fine.
I started another run last night. Only a partial run, 1 tray out of the 4 is all that’s in use (although it was pretty full). I’m controlling the method in which this tray is dried in order to provide a control for some experiments. Although it’s not done yet, I can say with confidence that one of the ideas I had for a freeze dryer is current a definite win and something that will improve the process significantly. If I get to, I’m going to name my method of freeze drying the “Ledford Method”
OK, so I thought I would run another batch of freeze drying yesterday. As some of you may remember, I currently use a blender to convert the ice cubes of pre-frozen material into a snow like powder. Well, when running the blender, less of the ice melts if you pre-chill the blender container in the freezer for an hour or so. However, evidently, that makes the polycarbonate they make these blender containers out of sort of brittle. Go here to see what happens then…
So, after I destroyed all three polycarbonate blender containers, I called United Restaurant Supply and asked if they had any blenders with stainless steel containers. They did, so I went down and bought two. I came home, I pre-chilled the stainless steel containers, I put them both on their base units, I fired them up with about 4 ice cubes in each, and one managed to snap its drive shaft in the container and the other managed to chew up the rubber drive pieces that interconnect the blender motor and the blender container.
1 day, about a total of 3 ice cube trays worth of product blended. Three blenders, two of them stainless steel commercial models, destroyed. What a bitch. I have to wait until after Christmas to find out of I can take the blenders back for either a refund or exchange (refund preferred) or send them off to a factory repair center to get them fixed.
I did, however, come up with a plan to keep this from happening again. I want to get an ice crusher and use it to pre-crush the ice cubes before they ever go in the blender. I have a feeling that the smaller chunks won’t be so hard on the equipment and it will be able to hold up under that kind of load.
just how much water came out of that freeze drying run, here’s the ice chunk from the condenser after several hours of melting
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- From the side
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- From the top
Yes, yes…I know I have webbed toes….shut the hell up.
I ended up with just barely a small amount that didn’t get totally dried. All in all, it took 2 days.
How much I managed to do in this partial run
Freeze drying is actually an expensive process, energy wise. It consumes large amounts of energy to generate both the cold and the vacuum needed. However, once you’ve got the vacuum and the cold, neither of these items are strongly tied to the amount of stuff you are freeze drying. And the drying process proceeds at a specific speed in the stuff being dried regardless of how much is there. So, the more stuff you can get in your chamber, the less it costs on a per unit basis to do the drying. I’ve been doing very small runs of drying using a bench top freeze drier. It only had a roughly 5 1/2″ diameter tray that could only be piled up with about 1″ deep of stuff. Well, that’s no more. I still have the bench top unit, but I plan on getting rid of it. Instead, I bought and reconditioned a roughly 30 year old unit (that was in fabulous shape for its age…) that has 4 shelves, and each shelf has a 12″ x 17″ x 2″ deep tray for holding material. I fired it up for its first real run tonight. I expect it to take a day or two to complete the run, but instead of having a few tablespoons full of product when it’s done, I’ll literally have multiple cups of stuff.