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Author Archive | Mike Tousey

Certified?

Certified?

Certified? We have had several customers ask recently about the new Dietary Supplement GMP’s, and one of the most misleading rumors has been that companies need to be certified or have some kind of “FDA certification”. This is simply not true. The FDA does not, and will not come to your facility and certify that you are compliant. They will inspect your facility and evaluate your level of compliance to the official GMP regulations.

To add to the confusion, there are several companies that do provide “certification”, like NSF. The FDA has not provided approval for NSF to go to companies and certify them…they simply do not do that. Just because you are certified by a company like NSF does not mean you will be compliant with current FDA GMP’s. It only means you are certifying that you have met the NSF requirements, which has turned into a marketing tool. Just look at the ads and company’s propaganda and see how many say they are NSF GMP Certified. I’m not saying that NSF, or other companies that provide “certification” are not providing a good service, they are! I’m simply trying to make it clear that being certified by anyone does not mean a company will meet the FDA’s GMP regulatory requirements and suddenly become compliant.

Our goal has been, and continues to be, helping manufacturers understand what it means to become FDA compliant and remove the confusion. Our “GAP” analysis is the best place to start and this is something we can help you with. A GAP analysis simply establishes where a company is now, and where they need to be. We help to develop on-going strategies to meet or exceed cGMP’s. The little “c” in “cGMP’s” stands for “current”, meaning that companies cannot just complete a few tasks and thus, they have arrived and can be certified; no such thing. A company must develop an on-going philosophy of continuous quality improvement.

So what do you need to do? In 2 ½ hours you can get a much better grip on it by listening to our session on Dietary Supplement GMPs 101 – New Ruling at https://techceuticals.webex.com. Then call us and find out what a GAP Analysis audit can do for your company.

Is your tablet capping?

Is your tablet capping?

Last week we had some really good participation for our Tablet Capping webinar…thanks to all that attended.  This is one of those defects that can be really frustrating because once you feel you have a product figured out, and have it fine tuned, suddenly capping occurs. Getting the air out from between particles without moving the “fines” to the “air evacuation point is the key to success”.  During compaction as the upper punch tip enters the die, air is being pushed out of the die.  The design of the upper punch tip being smaller than the lower creates an avenue for air to escape. I call the point between the upper punch cup edge and the die wall the point of “air evacuation”.  As the air moves and evacuates it takes with it many of the dusty, fine, dry, light, non-compressible particles.  These particles can form a line along the point of air evacuation between the top of the tablet (aka the “Cap”) and the “Band” of the tablet, forming a line of non-compressible particles, which results in the “cap” not adhering to the rest of the tablet. The use of pre-compression is to lightly tamp or lock the small particles in place so they cannot migrate during final compression.  Upper punch penetration is another tool most modern machines have; adjust it as high as possible and the air will have a shorter distance to travel allowing for more complete air evacuation.  Machine speed can also play a roll to prevent capping because the time to evacuate the air is related to the clearance between the upper punch tip and the die wall and the depth of punch penetration…basically slowing the press gives the air more time to leave without pushing the fines to the air evacuation line which will result in capping.  If you want to fix capping…

  1. Optimize weight control
  2. Reduce Punch Penetration (2-3mm)
  3. Use pre-compression to lightly tamp
  4. Slow the press down until capping stops
  5. Add a taper into the die
  6. Change the radius of the upper punch tip to a compound radii
  7. Use a machine with 2 pre-compression stations (like a Manesty Nova)
  8. Reduce the percentage of fines within the formula.

Never change more than one item at a time and test to see the result.  Call or write to me if you need me to clarify any of this information.

Humidity & Temperature in Tableting

Humidity & Temperature in Tableting

RH…relative humidity & temperature in tablet manufacturing must be “constant”…variations are what cause so many problems.  There is no one perfect number for all products as the nature of raw materials is so different. Each and every powder reacts differently to temperature and humidity.  For some products very dry air will cause segregation of ingredients, and too high of humidity for others will cause huge sticking problems.  The key is maintaining a constant temperature and humidity. Most companies have low temperature and average humidity in the early morning hours; but, as the day progresses, machines and rooms’ heat up, and humidity from the outside changes, this creates problems so much so that the way a product runs in the morning is completely different than how it runs in the afternoon hours.  I have customers that cannot run certain products on rainy days or when the temperature is too high…conversely I have customers who cannot run products when it is to dry.  The bottom line is that humidity & temperature must remain as constant as possible…so look at when your product is most successful and when it is troublesome and you will have established parameters to guide you and to use as a caution to avoid problems.

Welcome

Welcome

Welcome to the Techceuticals new “blog”. We want to offer the best communication and provide our clients and customers an opportunity to ask questions and be involved in a 2-way exchange.  Techceuticals offers a wide range of services designed to provide solutions in training, troubleshooting, equipment, quality & regulatory areas and problem solving in processing, manufacturing and packaging.   This format should help to provide new ideas and at the very least provide some thought provoking ideas and help. This is not the only avenue, we want to make certain that everyone feels free to email or call us directly.  Our objective is to make certain our door is open to improving the quality of the products we all make, and the way in which we deliver that quality starts right here with improved communication. We believe that if you are not part of the solution you are part of the problem…we at Techceuticals have made it a “must” to being part of the solution…this is our goal.