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I’ve been working in a compounding pharmacy for 19 years at the time of this blog post. I have made a countless number of capsules with the Jaansun Capsule Machine from PCCA. They had it when I started and we still use it today. It can make from 1 to 100 capsules, in one load, sizes 4 – 000.
Making Capsules Guide
PCCA filed for a patent February 6, 1992 and the application was granted February 6, 1994. The life of this patent was 14 years so the status is now expired and is in public domain. There are different capsule making machines out there now, but I’m gonna give you tips on using the Jaansun since it is the only one I’ve used. The tips will probably apply to other capsule machines.
We use hoods for the protection of our employees in the lab. These hoods are Class I biological safety cabinets that contain airborne particulates and powders, providing user protection during hazardous drug compounding or pharmaceutical manipulation. They meet the USP <800> requirements for non-sterile hazardous compounding. These systems exhaust air through two levels of HEPA filtration, returning it safely to the lab.
Your chemicals and fillers have to be mixed well before going into the capsules. Sometimes color is added for a visual reference. You can use a mortar and pestle, a sieve and/or an electronic mixer like this Speed Mixer.
Preparing Your Equipment
Read your formula to determine capsule size (4-000), capsule style (clear clear, opaque clear, color) and number of capsules needed.
If your formula calls for more than 100 capsules you’ll want to split in even numbers (120 capsules = 2 setups of 60 – 360 capsules = 4 setups of 90 – etc.). Split your powder accordingly if not already provided that way.
This is the capsule machine base unit. You’ll now need to pick out a set of plates, of the needed capsule size, to use with the machine:
Black Pinch Plate
White Pinch Plate
Solid Top Plate
Here are all the Separator, Pinch and Loader plates sizes from the smallest, size 4, to the largest, size 000. The sizing notch(es) represents the size of the black and white pinch plates, the separator plates and the black and white loader (see below) plates.
There are black and white pinch plates. The hundred holes are slightly offset from each other on the different colors to lightly pinch the base of the capsule so the lids can be removed. You always place the black pinch plate in the slot first with the sizing notch facing you.
The white pinch plate then slides in, with the sizing notch facing you and lining up with the notch on the black plate.
The separator plate then fits over the four metal tabs. This will be used to separate the lids from the bases of the capsules. The sizing notch will face you and line up with the black and white plate notches.
While it will still work if you turn the sizing notch to the back on one plate and to the front (or also back) on the black plate and separator plate, I don’t recommend it. When not making a full 100 capsules you’ll have to be certain to turn the plates in the directions you started with when finishing. Eventually you’ll fail to do this and be starting over. Always face the three sizing notches toward you and it won’t be an issue.
Adjusting Capsule Size Level
You must adjust the plate in the middle of the machine based on your capsule size (length). There are 4 screws that must all be adjusted exactly the same.
Turning the screws all the way to the right, by hand, will bring the plate to capsule #4 level. All the way to the left will be the capsule #000 level. To try to keep the plate level, if I’m going down from #4 to #1, I’ll count the turns of the screw and try to repeat the same number for the other three.
Screwing them to the right will bring the plate up and screwing them left will lower the plate.
This takes some practice but is really important to end up with a plate that is level and does not rock at all.
It is time to decide how to line up the capsules in your machine. If the formula calls for 28 capsules you’ll want to set-up 4 rows of 7 capsules, if 12 capsules you’ll want 2 rows of 6 capsules (try your best to keep your capsules in rows or columns of 5 or more since the tamper device needs 5 capsules to work properly -more on that to come, if 36 capsules you’d want 6 rows of 6 capsules or 4 rows of 9 capsules, etc.).
If your formula calls for a number of capsules that cannot be divided evenly (like 57) then you’d have a row or column with the left over capsules in it. You’ll just have to tape off unused holes accordingly (57 = 5 columns of 10 capsules with 7 capsules next to it or 9 columns of 6 capsules and 3 capsules next to it)
Capsule Loader Machine
This is the Loader. You can use it to ease the effort of dropping your capsules into place. It drops a maximum of 50 capsules at a time. The black plastic vertical piece on the front pushes downward to load the plates and upward to hold the plates in place.
The black loader plates slides in the bottom slot, sizing notch facing you just like the pinch plates.
The white loader plate slides in the top slot, above the black plate, sizing notch facing you. Slide the black plastic vertical piece upward to hold the plates in place.
Think of your capsule plates as columns. 1-10, left to right. If you are filling 60 capsules you’ll want to fill columns 3-8. If filling 30 you’ll want either 4-6 or 5-7. If you’re filling 90 capsules you’ll use 1-9.
So, in the Loader to fill 60 capsules you’d load 3,5,7 and drop (push the white plate inward) those to the left and then load 4,6,8 and drop (push the white plate inward) those to the right. For 30 capsules you’d load 5,7 and drop to the left and then 6 and drop it to the right.
For 90 capsules you’d load 1,3,5,7,9 and drop them to the left and then 2,4,6,8 and drop them to the right. For all 100 capsules you’d load 1,3,5,7,9 and drop to the left and then 2,4,6,8,10 and drop them to the right.
If you are making 30-100 capsules the loader can save time. Drop your capsules in the holes, it doesn’t matter which way the top of the capsule faces (they will drop in correctly). Push the machine far to the left and push the white plate inward. Lift the loader upward and set aside.
Gently push down on the capsules to seat them into the holes. If they won’t go , do not force them as they will lock. Drop the capsule machine front door and gently adjust the black and white pinch places until you can push them down easily.
If the capsules will not settle down into place check/try these things:
*Open the front door and use your finger to adjust the black and white pinch plates until the capsules fall in
*If capsules were washed in the machine they leave a gelatin residue in the holes, use tweezers to remove it
*If tape was left on the plate it may still be there – or it may have left a sticky residue that you’ll need Goo-Gone to remove
Replace the loader and reload with the appropriate number of capsules, push to the far right and repeat. Lift the loader and gently push all the capsules down into place. You are done with the loader.
Like I said, if making 30 to 100 capsules the loader can save time. From 1-29 I like to load by hand. You should load them as close to center of the machine as possible. This will benefit you when you are lifting up to reconnect the capsule lids and bases later. The short section, top, of the capsule goes up the long section, bottom, goes down.
Separating Your Capsules
Now it is time to separate the bottom of the capsules from their tops. Place your solid top plate in place. It is completely flat on the bottom and has two grooves on the top. The grooves are for the black rubber knobs to twist into. Make sure the grooves are turned upward and twist the knobs into place so that it holds the plate firmly.
Tighten the front two black pincher knobs to hold the bottoms in place. You need to twist them firmly tight but do not wrench them down.
Now put your thumbs on the two back metal machine pieces and your fingers under the top plate and squeeze them together. Repeat with the other two and turn the top over.
If some of the capsule bottoms are still in the top, simply pull them out and place into the pincher plates. Now loosen the front knobs and the capsule bottoms will fall down to the machine. If you adjusted the machine plate correctly the capsule tops will be just under the white plate top level.
You can now take a credit card and run it, on it’s side, over the white plate. If the capsules are a little too high you will hear clicks and adjust accordingly.
Filling/Closing the Capsules
Now it is time to tape off the capsule columns (and/or rows) that you didn’t use. Make sure your tape is a little longer than the plates so that you can fold over a tab to make it easy to remove. If you’re making 60 capsules then you’ll tape off columns 1,2 and 9,10.
If you put too many capsules in your machine, say the formula was for 90 and you used all 100, this is not an issue. Simply tape over the excess capsules. At the end you’ll have, in this case, 10 empty capsules to throw away.
You will need to wear a mask and gloves for the protection of yourself and the product. These items are known as personal protective equipment (PPE).
Static is your enemy! If there is static it will play havoc with fluffy powder causing it to fly everywhere. You can use a static cling dryer sheet to wipe down the surfaces of your plates before adding the powder. Make sure you rub down your credit card also. I’ve seen times that the powder is repelled when you try to push it with the card.
Make sure your work surface has been thoroughly cleaned before starting.
Pour your powder onto the center of the capsule machine.
Now use a credit card to push the powder around and into the capsules. You want to avoid the edges of the machine the best you can. The idea here is to get the same amount of powder into every capsule. Once they are all full, gently and carefully lift the machine and tap (several times) it on the surface. This will cause the powder to pack into the capsules. Repeat using the credit card to fill the capsules again.
If you have too much powder for the tapping method you’ll need to use the tamper (I prefer to call it the Pushy-Downy-Thing). As evenly as possible, you need to push the powder downward into the capsules (5 at a time). You have to be careful and don’t push too hard, especially if you don’t have a lot of powder remaining.
When using the tamper, push all the remaining powder to the top or bottom of the plate. Push the tamper into the holes across the opposite section, then push the powder onto to tampered area and repeat with the rest of the capsules. How hard to push is a thing you’ll learn over time, just don’t push too hard as you could damage the capsules.
If you can’t get all the powder into the capsules stop and check a few things:
* Do you have the correct size capsules
*Do you have the correct number of capsules
If so, then you will have to try a dangerous thing, slightly lower the bottom plate. If you’ve never done this before it’s time to call for help. If you lower them enough for the top of the capsules to be below the top white plate then you’ll probably not be able to close your capsules.
If there is too much or not enough powder you need to alert the Pharmacist. The formula should be corrected. Before lowering you should weigh the excess powder and record. This will be used to possibly reduce the filler contents in the formula. If not enough powder you may need to add filler.
Add the filler until you capsules are full then dump the entire content onto a large piece of aluminum foil. Keep track of the weight of anything added for the formula update. Remember this added filler will have to be thoroughly mixed into your powder before returning it to the capsule machine.
They make a plastic powder retainer square that you can place on the machine to help control the powder. Remember, powder will get under the retainer so be sure and remove it and then finish pushing the powder into place..
Some people like to build a “tape dam” around the edges of the machine. This can keep the powder contained and out of the machine cracks and crevices. I don’t really like the plastic powder retainer square, I just try to be careful. If you need something to help you with the powder containment I’d go with the “tape dam” method.
There is also a Jaansun Powder Vibrator (Model 200) that you can place your capsule machine on that will vibrate and settle your powder more efficiently than tapping will. It is handy for some powders that are very fluffy and require extra packing time.
If static or pushing too wildly (I’ve done it many times) causes powder to fall off the machine and onto the work surface you’ll need to get that back into your capsules. I use another credit card, preferably thinner, and push all the surface powder up and onto the thin card. This is why you’ll require a really clean surface before starting.
Once the powder is loaded, pull your tape off. Some people will wait until later but do not follow their example. The tape can hinder the movement of the pinch plates and cause you problems. Make sure you press down on the top plate with one hand while pulling the tape off with the other. This will keep the machine from coming off the table and dislodging your powder.
Now, with the powder loaded, pull off any tape and replace your separator plate (sizing notch facing you). Loosen the two black pincher knobs and tap the front door toward the back. Place your thumbs on the top solid plate and your other fingers underneath the lower lift plate. Squeeze your finger up to your thumbs (both sides at the exact same time) and you should feel the capsule bottoms push up into the capsule tops.
Make sure the solid top plate stays secure at all times. If it comes loose the tops of the capsules will come out of their holes and are difficult to re-insert.
Do not force the capsule bottoms upwards. If it is hard to do something is wrong. Tap the front door towards the back a few more times and gently lift again. If it still doesn’t connect then ask for help.
If you push too hard capsules can dimple. This does not ruin the effectiveness of the capsule but makes it look bad and could crack it open. Do not force the capsules. Once the capsules are pushed up into the tops remove the separator plate and turn it over. If any of the capsule bottoms stay in the pincher plates then replace the separator plate and try again. If this persists, ask for help.
Once the capsules are pushed up, into the tops, remove the separator plate and turn it over. Now gently push down on every capsule and it should lock into place. Once locked, turn back over and remove the solid plate and pour the capsules onto a paper towel. When you put the capsules in a vial leave the paper towel on your surface to remind you that this area is in need of cleaning with alcohol.
When locking, if there is too much powder in the capsules they cannot get to the place where they lock. You’ll just have to leave them unlocked because if you try to force them to lock they will dimple or crack open.
Finding Your Percent Error
Now it is time to see how you did. You are going to take the theoretical pack rate of your capsules from your formula sheet, your actual fill rate by weighing your capsules and find the percent error. It must be plus or minus 10 percent.
Quality control by your pharmacy ensures that the capsules are plus or minus ten percent which is required by USP795 Guidelines which govern non-sterile compounding. This can be found in #1163 “Quality Assurance in Pharmaceutical Compounding“.
Add the components of your capsules. Here it is 2 drugs, 2 fillers (E4m and Lactose) and a color (blue).
Take the total grams (11.67 gm) and divide by the number of capsules (60) you used. The theoretical weight of each of your capsules is 0.1945 gm.
Now you need your actual capsule weight. We are going to take an average of 10 capsules. Get 10 empty capsules of the size you used (this example is #3) and put them in a weigh boat, place them on the balance, and press “Zero”. This will eliminate the weight of the capsule shells and weigh boat from your calculations.
Now, remove the 10 empty capsules and replace them with 10 of the ones you just filled. This is the weight for 10 capsules so divide by 10 and you’ll have the actual weight of 1 capsule (1.905 gm divided by 10 = 0.1905 gm or 190.5 mg).
You’re almost there. Now subtract your actual (0.1905 gm) from your theoretical (0.1945 gm) and you’ll get your error percentage (0.02 x 100) 2% in this case. This is well within your requirements of plus or minus 10%.
I like to do all the calculations in milligrams (mg). It may just be me but I find it easier. In the example above it would be 194.5 minus 190.5 = 4 divided by 194.5 = 0.02 x 100 = 2 % error.
You’re done, Well almost, it’s time to clean up. Carry everything you used to the sink area. The first thing to do is adjust the capsule machines lower plate level back to #4 capsules. This will prevent an error by you or a co-worker that forgets the step to set the plate level for the capsule being used next. Say if you’d been making #1 capsules and the next set was #4, they would just fall right through if not adjusted causing you to start over. I like to use this Allen tool (9/64 Eklind). Just insert and turn gently until they stop all the way up (to the right)
Now, using dishwashing soap and a sponge, wash each piece of your capsule machine. Make sure to wash any powder out of the groves in the capsule machine. If it dries in there it will cause the plate to pinch incorrectly. The most important part of this process is tapping the water out of all the holes in the plates.
If you don’t, the water that has wicked into the holes will not dry quickly. I’ve come in the next day and found water still in the holes. Dry everything off and place in a drying rack. Placing everything neatly in the rack will aid you and your co-workers. Turn all the sizing grooves upward and keep the size types together. A fan, like the one on the wall here, helps dry the capsule machines quickly. Properly dried plates in this set-up are usually dry in about 15 minutes and ready to use again.
|◯||1) Read the formula to determine capsule size and number|
|◯||2) Make sure your powder is thoroughly mixed|
|◯||3) Get a capsule machine base unit, appropriately sized black and white pinch plates, an appropriately sized top separator plate, and a solid top plate|
|◯||4) Adjust the height of the bottom plate based on the capsule size|
|◯||5) Assemble the capsule machine, and leave the knobs loose|
|◯||6) Add capsules (by hand or with loader), and adjust pinch plates to let capsules settle into place, put solid top plate on, then tighten the knobs|
|◯||7) Separate capsule tops from bottoms by removing the separator plate|
|◯||8) Loosen the knobs, gently push capsules down to level them, with the white plate, using a credit card to check, tighten the knobs|
|◯||9) Tape off unused holes|
|◯||10) Add powder and rake into capsules filling capsules evenly|
|◯||11) Remove the tape|
|◯||12) Replace the separator plate, loosen the knobs|
|◯||13) Squeeze capsule bottoms back into their tops|
|◯||14) Remove the separator plate and turn it over|
|◯||15) Lock capsules|
|◯||16) Remove the solid top plate. Turn back over and dump capsules onto a paper towel, Place capsules in a vial|
|◯||17) Perform your percent error calculations|
|◯||18) Label your capsules and complete the paperwork|
|◯||19) Wash your capsule machine and parts|
|◯||20) Clean your work surface thoroughly|