Factors affecting the accuracy of capsule filling machine loading
2021-06-03 10:03:01
Most of the domestic capsule filling machines are mainly filled type quantitative method, and the filling amount is determined by the thickness of the measuring plate, which is related to the bulk density of the filling material. At the same time, the accuracy of the filling capacity control is related to the influencing factors of the filling structure and the influencing factors of the filling material itself.
1. Analysis of influencing factors of filling structure For the capsule filling machine of the filling type quantitative method, the filling amount of each capsule can be expressed by the following formula: W=kψÏλV=kψÏλπ/4×D2h, where W is for each capsule. Filling weight, mg; k is the filling rod preset coefficient, which is related to the initial pre-adjustment position of the five-position filling rod; ψ is the filling coefficient of the material; Ï is the bulk density of the material, mg/mm3; λ is the filling rod pressure Influence coefficient; D is the diameter of each metering hole in the metering disc, mm; h is the thickness of the metering disc, mm. The above formula can be simplified to Table 1 according to the different metering apertures configured for different capsule models.
Table 1 relationship between capsule model and capsule filling weight
It can be seen that when the thickness h of the metering disc is constant, the variable factors affecting the accuracy of the filling capacity are related to k, ψ, Ï, λ.
1.1. Filling rod preset position coefficient k.
Because there are six station filling holes and corresponding filling rods on the general metering disc, and the initial pre-adjusting position of the filling rod (ie, the depth at which the punch is pressed into the filling hole) (as shown in Figure 1), five of them are considered. The station filling rods participate in the compaction of the material, and a station filling rod presses the powder column in the metering hole into the capsule body. However, the initial pre-adjustment position of the five station filling rods determines the weight of the powder cylinder that is pressed into the metering orifice. As shown in the figure, the depth of the pre-adjustment position of the filling rod into the metering hole is set to Δhi, and the depth Δhi of the pressing pre-positioning position is different, and the influence on the filling accuracy is also different. For this purpose, the filling rod preset coefficient k is introduced. According to the theoretical analysis and actual statistics, the preset position coefficient k of the filling rod can be obtained close to the following formula: k=1+ΣΔhi/5.5h, where k is the filling rod preset position coefficient k; h is the thickness of the metering disc, Mm; Σ Δhi refers to the sum of the filling rods of the first station to the fifth station, respectively, into the pre-adjusted position depth, Σ Δhi = Δh1 + Δh2 + Δh3 + Δh4 + Δh5 (mm). In general, the larger the pre-adjusted position depth sum ΣΔhi, the larger each capsule is loaded on the same metering disc. However, if the amount of ΣΔhi is too large, it will cause the filling to be too tightly compressed, resulting in a phenomenon of “stuffing powderâ€. According to the experience of use, the recommended range is 0 ≤ Σ Δhi ≤ 0.35% h, and Δh1 to Δh5 in Δhi are arranged in descending order. When the theoretical volume of the metering hole in the metering disc is close to the capsule loading, the amount of Δh1 to Δh4 can be selected to be small or close to 0, but Δh5 is selected to be 1-0.5mm slightly to reduce the "flying" of the metering disc during intermittent rotation. Powder phenomenon.
1.2. Filling factor of materialsψ
Due to the smoothness, particle form and angle of repose of the filling itself, the capsule filling capacity produced under the same metering hole, filling rod pre-positioning depth and filling rod pressure is slightly different. According to different filling materials, the empirical data can be obtained when certain parameters are selected. The empirical data can be tested and calculated according to the formula: ψ=W/0.785kψÏλD2h The author can obtain the reference materials in Table 2 after years of statistical calculation. After the filling factor is ψ, it can be seen that when 3% to 5% of magnesium stearate lubricant is added to the material, the slipperiness is increased. Then, when referring to the filling coefficient of the above materials, the correction can be repeated by the formula according to the net weight of each capsule weighed.
Table 2 Material Reference Filling Factorψ
1.3, the bulk density of the material Ï
The bulk density of the filling material is related to the dry granulation, pulverization and mixing process of the production process, in addition to the material itself. Generally, the bulk density of a material is measured by random sampling. It is reflected in a certain representative density of the material and cannot truly reflect the bulk density of the whole material. Of course, it is related to granulation and pulverization uniformity and mixing uniformity, mainly mixing uniformity. The main mixing equipment for solid preparations is two-dimensional motion and three-dimensional motion cylinder, double cone and V-type mixing. The mixing uniformity is related to the mixing equipment model and the charging coefficient and mixing time. Here, the mixing uniformity can be judged by the coefficient of variation v. The closer the general coefficient of variation is to 0, the more uniform the mixing. In order to study the accuracy of capsule filling, the bulk density Ï of the sampled material is different from the bulk density Ï' of the actual filling material, which is related to the mixed coefficient of variation v. The author can obtain the following empirical relationship after years of statistical data (Ref. Sexual data), as shown in Table 3.
Table 3: Reference of mixed coefficient of variation and actual material bulk density
It can be seen that the more uniform the material is mixed, the more accurately it can reflect the bulk density of the filling material, and the corresponding filling accuracy is also higher.
1.4, filling rod pressure influence coefficient λ
Generally, the filling rod of the same model and the same manufacturer's capsule filling machine is certain, but in order to adapt to the production of traditional Chinese medicine capsules, the filling rod impulse with increasing torque has solved the requirements of the viscosity and large capacity of the traditional Chinese medicine capsule. In order to discuss the accuracy of the capsule filling capacity, the filling rod pressure influence coefficient λ is introduced here. For the capsule filling machine using the filling rod impulse with increased torque, the filling rod pressure influence coefficient λ can be taken as 1.02-1.06, and the general capsule The filling machine λ takes 1.
2. Analysis of influencing factors of filling materials themselves 2.1. Flowability of filling materials The fluidity of filling materials also refers to the smoothness. The filling materials often have powders and granules. The fluidity of the filling materials will directly affect the capsule loading. Control of volume accuracy. The angle of repose, bulk density, particle size distribution and water content of the filled powder or granule directly affect its fluidity.
In general, when the filled powder or granules are piled up, the granule angle of repose is smaller than the angle of repose of the powder, so the fluidity of the granules is good, and the precision of the filling of the capsule filling is easy to control. The bulk density refers to the weight per unit volume of the powder or granule. During the filling process, the weight per unit volume is large, the fluidity is good, and the filling accuracy of the capsule filling is easy to control; otherwise, the weight per unit volume is small. The fluidity is poor, and it is difficult to control the accuracy of the filling of the capsule. In the practice of capsule filling, when the bulk density of the filling drug is above 500 mg/ml, it is easy to control the filling accuracy of the capsule filling, and when the bulk density of the filling medicine is below 450 mg/ml, it is difficult to control. Capacitance filling accuracy.
2.2. The hygroscopicity of the hygroscopic filling material filling the material also affects the control of the capsule loading accuracy. When the water content of the filled powder or granule is higher, the viscosity is larger, the fluidity is worse, and the viscosity is too large. (Silver powder refers to the fact that the powder column can not be pressed in the metering hole of the metering disc under a certain filling rod pressure), and the water content control of the general filling medicine in the mixing or granulation process is less than about 4%. In addition, the hygroscopicity of the filling material is related to its critical relative humidity. In general, when the purity of the filled powder or granule is not high, the critical relative humidity is lowered, and the multi-component also increases the hygroscopicity. Both of these will increase the viscosity of the filling process, which will make the loading larger, and the above-mentioned "powdering" phenomenon is likely to occur. Excessive moisture absorption can also cause decompression of the drug. In this way, it is necessary to control the environmental humidity at its critical relative humidity during the filling process, and the relative humidity corresponding to different drugs is also different, such as penicillin ≤ 47%, and aminoglycosides ≤ 58%. However, the capsule body has certain requirements for humidity. If the humidity is too low, the capsule body is easily broken, so the humidity of the capsule filling environment is generally controlled at 40-60%.
For the varieties of traditional Chinese medicine capsules, some of the powders are too sticky, and the capsule filling is not stable. How should it be solved?
Because the problems involved in such problems are more complicated, so roughly analyze:
1. If the viscosity of the traditional Chinese medicine is caused by moisture absorption, the key is to pay attention to the extraction process, properly carry out water extraction and alcohol precipitation, improve the process, minimize the absorption of hygroscopic components (of course, it is an ineffective ingredient), and try to retain a part of the starch. More raw medicine, add after crushing! Of course, it is also possible to add an acrylic resin or the like for treatment to reduce hygroscopicity.
2. If it is a prescription excipient problem, it is necessary to re-adjust the prescription. It is recommended to add microcrystalline fiber or the like to help the adsorption of the powder, disperse the auxiliary or increase its dosage. For example, change the sucrose to lactose or mannitol to reduce the hygroscopicity. ......
3, increase the flow of agents, such as micronized silica gel, MgO, magnesium stearate and so on.
Other measures are as follows:
1. Dry the powder as much as possible. The lower the moisture, the better. 2. Control the humidity of the workshop, make it as low as possible, and keep the temperature as low as possible. 3. Increase the amount of magnesium stearate.
4, pharmaceutical packaging must be able to effectively moisture.
5, the fine powder loading of the powder will be a little better.
6. Check if the position of the filling machine module and the metering tray are installed. The powder in the powder ring is less good, and the powder is not too much.
To fill at high speed, replace worn wear rods in time. Stick to the outer wall of the capsule and polish and pack it in time.
Through the above discussion, it is basically able to solve the phenomenon that the difference in the amount of loading that occurs in the production engineering is too large. It is also hoped that the friends of all circles of the pharmaceutical industry will put forward more reasonable suggestions, so that the capsule filling machine has wider applicability.
1. Analysis of influencing factors of filling structure For the capsule filling machine of the filling type quantitative method, the filling amount of each capsule can be expressed by the following formula: W=kψÏλV=kψÏλπ/4×D2h, where W is for each capsule. Filling weight, mg; k is the filling rod preset coefficient, which is related to the initial pre-adjustment position of the five-position filling rod; ψ is the filling coefficient of the material; Ï is the bulk density of the material, mg/mm3; λ is the filling rod pressure Influence coefficient; D is the diameter of each metering hole in the metering disc, mm; h is the thickness of the metering disc, mm. The above formula can be simplified to Table 1 according to the different metering apertures configured for different capsule models.
Table 1 relationship between capsule model and capsule filling weight
Capsule model | 0# | 1# | 2# | 3# | 4# |
Measuring hole aperture mm | Φ6.3 | Φ5.65 | Φ5.2 | Φ4.8 | Φ4.3 |
Filling weight of each capsule W (mg) | 31.16 kψÏh | 25.06 kψÏh | 21.03 kψÏh | 18.09 kψÏh | 14.51 kψÏh |
It can be seen that when the thickness h of the metering disc is constant, the variable factors affecting the accuracy of the filling capacity are related to k, ψ, Ï, λ.
1.1. Filling rod preset position coefficient k.
Because there are six station filling holes and corresponding filling rods on the general metering disc, and the initial pre-adjusting position of the filling rod (ie, the depth at which the punch is pressed into the filling hole) (as shown in Figure 1), five of them are considered. The station filling rods participate in the compaction of the material, and a station filling rod presses the powder column in the metering hole into the capsule body. However, the initial pre-adjustment position of the five station filling rods determines the weight of the powder cylinder that is pressed into the metering orifice. As shown in the figure, the depth of the pre-adjustment position of the filling rod into the metering hole is set to Δhi, and the depth Δhi of the pressing pre-positioning position is different, and the influence on the filling accuracy is also different. For this purpose, the filling rod preset coefficient k is introduced. According to the theoretical analysis and actual statistics, the preset position coefficient k of the filling rod can be obtained close to the following formula: k=1+ΣΔhi/5.5h, where k is the filling rod preset position coefficient k; h is the thickness of the metering disc, Mm; Σ Δhi refers to the sum of the filling rods of the first station to the fifth station, respectively, into the pre-adjusted position depth, Σ Δhi = Δh1 + Δh2 + Δh3 + Δh4 + Δh5 (mm). In general, the larger the pre-adjusted position depth sum ΣΔhi, the larger each capsule is loaded on the same metering disc. However, if the amount of ΣΔhi is too large, it will cause the filling to be too tightly compressed, resulting in a phenomenon of “stuffing powderâ€. According to the experience of use, the recommended range is 0 ≤ Σ Δhi ≤ 0.35% h, and Δh1 to Δh5 in Δhi are arranged in descending order. When the theoretical volume of the metering hole in the metering disc is close to the capsule loading, the amount of Δh1 to Δh4 can be selected to be small or close to 0, but Δh5 is selected to be 1-0.5mm slightly to reduce the "flying" of the metering disc during intermittent rotation. Powder phenomenon.
1.2. Filling factor of materialsψ
Due to the smoothness, particle form and angle of repose of the filling itself, the capsule filling capacity produced under the same metering hole, filling rod pre-positioning depth and filling rod pressure is slightly different. According to different filling materials, the empirical data can be obtained when certain parameters are selected. The empirical data can be tested and calculated according to the formula: ψ=W/0.785kψÏλD2h The author can obtain the reference materials in Table 2 after years of statistical calculation. After the filling factor is ψ, it can be seen that when 3% to 5% of magnesium stearate lubricant is added to the material, the slipperiness is increased. Then, when referring to the filling coefficient of the above materials, the correction can be repeated by the formula according to the net weight of each capsule weighed.
Table 2 Material Reference Filling Factorψ
General condition of the material | Material slippery condition | Reference filling factorψ | With reference to the filling factor ψ lubricant |
Powder | Good slipperiness | 0.96-0.98 | 0.98-0.99 |
Poor slipperiness | 0.94-0.96 | 0.96-0.98 | |
Granular , ≥20 mesh | Good slipperiness | 0.98-0.995 | 0.99-1 |
Poor slipperiness | 0.965-0.985 | 0.98-0.995 | |
Granular , < 20 mesh | Good slipperiness | 0.96-0.98 | 0.97-0.99 |
Poor slipperiness | 0.95-0.97 | 0.96-0.975 |
1.3, the bulk density of the material Ï
The bulk density of the filling material is related to the dry granulation, pulverization and mixing process of the production process, in addition to the material itself. Generally, the bulk density of a material is measured by random sampling. It is reflected in a certain representative density of the material and cannot truly reflect the bulk density of the whole material. Of course, it is related to granulation and pulverization uniformity and mixing uniformity, mainly mixing uniformity. The main mixing equipment for solid preparations is two-dimensional motion and three-dimensional motion cylinder, double cone and V-type mixing. The mixing uniformity is related to the mixing equipment model and the charging coefficient and mixing time. Here, the mixing uniformity can be judged by the coefficient of variation v. The closer the general coefficient of variation is to 0, the more uniform the mixing. In order to study the accuracy of capsule filling, the bulk density Ï of the sampled material is different from the bulk density Ï' of the actual filling material, which is related to the mixed coefficient of variation v. The author can obtain the following empirical relationship after years of statistical data (Ref. Sexual data), as shown in Table 3.
Table 3: Reference of mixed coefficient of variation and actual material bulk density
Mixed coefficient of variation v | 0-0.05 | 0.05-0.1 | 0.1-0.2 | 0.2-0.3 | 0.3-0.4 | 0.4-0.5 | 0.5-0.7 |
The bulk density of the actual material Ï' | 0.999Ï | 0.996Ï | 0.992Ï | 0.99Ï | 0.985Ï | 0.98Ï | 0.96Ï-0.98Ï |
It can be seen that the more uniform the material is mixed, the more accurately it can reflect the bulk density of the filling material, and the corresponding filling accuracy is also higher.
1.4, filling rod pressure influence coefficient λ
Generally, the filling rod of the same model and the same manufacturer's capsule filling machine is certain, but in order to adapt to the production of traditional Chinese medicine capsules, the filling rod impulse with increasing torque has solved the requirements of the viscosity and large capacity of the traditional Chinese medicine capsule. In order to discuss the accuracy of the capsule filling capacity, the filling rod pressure influence coefficient λ is introduced here. For the capsule filling machine using the filling rod impulse with increased torque, the filling rod pressure influence coefficient λ can be taken as 1.02-1.06, and the general capsule The filling machine λ takes 1.
2. Analysis of influencing factors of filling materials themselves 2.1. Flowability of filling materials The fluidity of filling materials also refers to the smoothness. The filling materials often have powders and granules. The fluidity of the filling materials will directly affect the capsule loading. Control of volume accuracy. The angle of repose, bulk density, particle size distribution and water content of the filled powder or granule directly affect its fluidity.
In general, when the filled powder or granules are piled up, the granule angle of repose is smaller than the angle of repose of the powder, so the fluidity of the granules is good, and the precision of the filling of the capsule filling is easy to control. The bulk density refers to the weight per unit volume of the powder or granule. During the filling process, the weight per unit volume is large, the fluidity is good, and the filling accuracy of the capsule filling is easy to control; otherwise, the weight per unit volume is small. The fluidity is poor, and it is difficult to control the accuracy of the filling of the capsule. In the practice of capsule filling, when the bulk density of the filling drug is above 500 mg/ml, it is easy to control the filling accuracy of the capsule filling, and when the bulk density of the filling medicine is below 450 mg/ml, it is difficult to control. Capacitance filling accuracy.
2.2. The hygroscopicity of the hygroscopic filling material filling the material also affects the control of the capsule loading accuracy. When the water content of the filled powder or granule is higher, the viscosity is larger, the fluidity is worse, and the viscosity is too large. (Silver powder refers to the fact that the powder column can not be pressed in the metering hole of the metering disc under a certain filling rod pressure), and the water content control of the general filling medicine in the mixing or granulation process is less than about 4%. In addition, the hygroscopicity of the filling material is related to its critical relative humidity. In general, when the purity of the filled powder or granule is not high, the critical relative humidity is lowered, and the multi-component also increases the hygroscopicity. Both of these will increase the viscosity of the filling process, which will make the loading larger, and the above-mentioned "powdering" phenomenon is likely to occur. Excessive moisture absorption can also cause decompression of the drug. In this way, it is necessary to control the environmental humidity at its critical relative humidity during the filling process, and the relative humidity corresponding to different drugs is also different, such as penicillin ≤ 47%, and aminoglycosides ≤ 58%. However, the capsule body has certain requirements for humidity. If the humidity is too low, the capsule body is easily broken, so the humidity of the capsule filling environment is generally controlled at 40-60%.
For the varieties of traditional Chinese medicine capsules, some of the powders are too sticky, and the capsule filling is not stable. How should it be solved?
Because the problems involved in such problems are more complicated, so roughly analyze:
1. If the viscosity of the traditional Chinese medicine is caused by moisture absorption, the key is to pay attention to the extraction process, properly carry out water extraction and alcohol precipitation, improve the process, minimize the absorption of hygroscopic components (of course, it is an ineffective ingredient), and try to retain a part of the starch. More raw medicine, add after crushing! Of course, it is also possible to add an acrylic resin or the like for treatment to reduce hygroscopicity.
2. If it is a prescription excipient problem, it is necessary to re-adjust the prescription. It is recommended to add microcrystalline fiber or the like to help the adsorption of the powder, disperse the auxiliary or increase its dosage. For example, change the sucrose to lactose or mannitol to reduce the hygroscopicity. ......
3, increase the flow of agents, such as micronized silica gel, MgO, magnesium stearate and so on.
Other measures are as follows:
1. Dry the powder as much as possible. The lower the moisture, the better. 2. Control the humidity of the workshop, make it as low as possible, and keep the temperature as low as possible. 3. Increase the amount of magnesium stearate.
4, pharmaceutical packaging must be able to effectively moisture.
5, the fine powder loading of the powder will be a little better.
6. Check if the position of the filling machine module and the metering tray are installed. The powder in the powder ring is less good, and the powder is not too much.
To fill at high speed, replace worn wear rods in time. Stick to the outer wall of the capsule and polish and pack it in time.
Through the above discussion, it is basically able to solve the phenomenon that the difference in the amount of loading that occurs in the production engineering is too large. It is also hoped that the friends of all circles of the pharmaceutical industry will put forward more reasonable suggestions, so that the capsule filling machine has wider applicability.
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