Leaking is the big issue for softgel manufacturing and softgel quality during shelf life, ther are a lot factors for softgel leaking or slowly leaking in packaging:

• Quality of gelatin mass
• Production environment temperature and humidity
• Each parameters control during encapsulation
• Feature of fill material mixture
• Selection of the gelatin mass formula
• Preparation treatment of fill mixture or finness or evenness
• Matching selection on various fill material mixture and die roll size and die roll technics
• Encapsulation machine main shaft vibration ETC.

Those leaking happens many especially for the softgel capsule with paste suspension fill material mixture, typical exmples are bee propolis softgel, multivitamin and multi mineral softgel, chinese herbal extract powder or medicine with PEG supporter, soy phospholipid softgel (soybean lecithin), also tapioca starch veggie softgel etc., more seam can help for no leaking, this SEC new patent max seam die roll can greatly enlarge the softgel seam rate both on leading and trailing. Even there are existing similar technology from other countries suppliers, this max seam die roll from SEC improves the inefficient sides on the world current technology and makes it almost perfect on the max seam on various fill mixture materials, which have been tested by so huge amount softgel manufacturers in China and some overseas in the industries of supplement and pharma. Now its the good chance to introduce to the world (SEC only introduce the stable technology to overseas market after enough testing and users feedback).

Here taking typical exmple on the cranberry-lutein ester-beta carotene softgel capsule, this is the typical suspension softgel, its fill is composed of cranberry extract powder, lutein ester and natural beta carotene oil. Composition of anthocyanin (the active ingredient in cranberry extract powder) and lutein ester would decrease easily by the temperature, storage etc., quality controls during production and encapsulation shall be well noticed and controlled for their composition stability and so for softgel product quality stability. 

• 1. Gelatin cooking/melting

Gelatin mass cooking/melting preparation process for animal gelatin is almost the same as generally, by using the gelatin melting tank, on the gelatin mass formula and process, to have the gelatin mass complete melted, no any particle and well melted gelatin mass shall be available to well pass filter screen 100 mesh, viscosity could be around 15000-25000 cp or 20000-50000 cp depends on the gelatin raw material feature and the process.

• 2. Material mixing preparation

Fill material mixing preparation process can be mainly 3 types, simply mixing, heat mixing, heat homogeneous emulsifying, according to the softgel formula ingredient list and the feature of ingredient, working sequence of each type has big difference in their operation procedures. (For example when lutein mixing with L-canitine for softgel, because lutein has small fiber, its not soluble in oil, and only available to emulsify into oil, and with enough emulsification; L-canitine has big moisture absorption, its dissolved when big humidity, and melted into lumps when high temperature, its preparation shall be in environment low humidity low temperature; they shall be separately emulsified, after well treating each, mix them together until even.)

Fill material for this cranberry - lutein ester - beta carotene softgel belongs to the heating homogeneous emulsifying type, which can help to have the active ingredient of each composition even and better softgel seaming. By dispersion the  suspension agent, after decreased temperature and input ingredients according to sequence, mixing until the mixture even, then to have milling and homogeneous, make the final finished mixture fine to 120 mesh. 

• 3. Encapsulation

On the die roll type softgel encapsulation machine, its quite high efficiency and stable performance. Its important to choose the matching correct size and technics of die roll according to the softgel formula. During encapsulation, temperature and humidity in the encapsulation room are very important, room temperature shall be set 18-26℃ and most ideal on 22℃, humidity 25-30% for encapsulation. Several temperature parameters directly effect the softgel shape forming, wedge temperature for animal gelatin is mostly controlled in range 38-45℃, gelatin mass temperature is mostly in range 55-70℃, gelatin ribbon cooling drum temperature is mostly controlled in range 15-26℃, fill material mixture temperature no higher than 42℃, comprehensively adjusting on all of the 4 temperatures unitl all in balance to meet the production requirement. 

• 4. Drying

Drying in tumbler dryer or drying tray are the most often two types currently, choose the suitable drying type according to the softgel type and workshop structure, for example suspension softgel when not well encapsulaed is not recommended to have drying full in tumbler dryer; tapioca starch veggie softgel is better drying more on tray etc., drying temperature for this cranberry-lutein ester-beta carotene softgel is 18-30℃ and humiidty 10%-35% according to manufactured batches experiences, on the basic of well preparation and softgel encapsulation, its higher efficiency drying in tumbler dryer. (Because leaking happens very often by almost all possible sides improved during encapsulation but the not well treatment preparation of fill material mixture). According to the operation, put the oil absorption cloth in tumbler dryer basket, or use the softgel polishing equipment to have separate polishing, making the softgel appearance bright and no oil.

• 5. Inspection and packaging

There are still required humidity and temperature in room of inspection and packaging, 18-26℃ temperature and no more than 65% humidity are applied. Its recommended to not have high temperature and high humidity, which would have softgel shell absorbing water and softgel becomes soft, effect the softgel appearance. 

Accordingly there are key quality controls for this cranberry-lutein ester-beta carotene softgel:

• 1. Temperature

During production process of this softgel, if improper control on the wedge temperature, gelatin mass temperature, gelatin ribbon cooling drum temperature during encapsualtion softgel shaping, softgel would have leaking and deformation, and if too high temperature of fill material mixture, it effects the active composition of anthocyanin in the softgel.

Temperature is the most key controls, it shall be well controlled from 3 sides that fill material preparation process, encapsulation process, and fill material storage. During fill material preparation, it requires heating to melt the suspension agent, its relevant quite high temperature during the whole fill material preparation process, and after the suspension agent is melted, its important to decrease temperature to below 40℃ firstly, then to input main ingredient and mix, the same that during milling homogeneous process, temperature shall be well controlled. For this type suspension fill material material during encapsulation quite long hours, to keep temperature of mixture is also necessary adn control to be below 40℃ (continuing stirring in hopper of encapsulation machine can help to keep the even mixing). There should be some time after material is prepared and before encapsulation, storage during this time shall be still the same to keep temperature below 40℃. (Humidity is also key especially for the drying process, if too high humidity, drying would be not available, or even lead to softgel deformation).

• 2. Fill mixture material

Partical control, mix time, mix type for the fill material treatment are the keys to have fill mixture material reach the homogeneous requirement. Too big partical of fill mixture material would lead to the fill mixture material in separated layers (not even after storage) or partical remained at the trailing seam location of softgel which lead to the leakage; no enough mixing time would have mixing not evenly; mixing type shall be homogenous mixing, whose mixing speed faster and have mixing more evenly. 

During encapsulation, besides the temperature control and keep stirring, its storage shall be avoid light and seal. According to the fill material requirement, its also good to have high pure nitrogen protection during the seal storage. 

• 3. Softgel drying

On the base that softgel formula is confirmed, its pH value will not change mostly. While the water content in product itself during storage process would also lead to the active composition decreasing largely. This requires when during drying process, to control drying temperature not high, at the same time to have drying time not too short, too fast drying time would have phenomenons of fake dried or actually not dried, normally the qualified dried softgel shall have water content on its softgel shell 8-12%.

According to tests on the same test methods, after the quality controls, active composition of anthocyanin and lutein ester are quite stable. 

From this example, its obvious to see the effect factors, it has many sides, generally for suspension fill material, the softgel quality problems still occur no matter if max seam die roll is applied if the fill material is not well or correct treated; same that for softgel shell, a lot quality problems happen if the gelatin mixture is not well melted/cooked. While for these special feature of fill material or gelatin mass, max seam die roll can help to compensate the insufficient of material/gelatin mass treating preparation or strengthen to ensure softgel quality during whole shelf life in varous environment even its confident with good material/gelatin mass preparation. 

As above seam rate for the manufactured cranberry-lutein ester-beta carotene softgel on the SEC max seam die roll, its feedback by the user that its the biggest seam that they have been made even this shall be the most skilled softgel production team in China.

• When gelatin ribbon thickness 0.039 inch (1.0mm), first leading edge seam rate 136.5%, after trailing edge seam rate 65.2%;
• When gelatin ribbon thickness 0.035 inch (0.9mm), first leading edge seam rate 120.1%, after trailing edge seam rate 79.5%;
• When gelatin ribbon thickness 0.031 inch (0.8mm), first leading edge seam rate 101.2%, after trailing edge seam rate 90.4%;
• When gelatin ribbon thickness 0.027 inch (0.7mm), first leading edge seam rate 93.6%, after trailing edge seam rate 72.3%;

Leaking happens mostly on the trailing edge, higher than 60% and even high to 90% of the trailing edge can greatly help for no leaking on various softgel formula, at the same time providing valid accordance for softge leaking analysis. 

SEC the first softgel service platform in China with histroy origin in 1986, we are manufacturing and supplying the know-how operation, technical guidance and training, and one stop solution for reasonable matching between die roll and fill mixture material, fill material feature analysis support, onsite encapsulation, for your easy softgel production with better softgel quality and appearance.