In the production of softgel, it is very important to select the right gelatin performance indicators, because these indicators directly affect the quality and performance of softgel. The following are suggestions on how to screen soft capsule quality problems and specific indicators related to gelatin properties:
1. Gelling strength (Bloom value)
Importance: Bloom value is a key indicator of the strength of gelatin formation. For soft capsules, appropriate gelation strength can ensure that the capsule shell has sufficient strength and elasticity, and is not easy to break or deformation.
Screening criteria:
Type of application: Select the appropriate Bloom value according to the use of the softgel (such as medicinal, nutritional supplement, food). Typically, pharmaceutical softgel capsules require 150-250 Bloom, and the range can be adjusted if higher strength or flexibility is required.
Production conditions: Considering the capacity of production equipment and process control, the appropriate Bloom value should be selected to avoid increasing production difficulty due to too high or too low gelling strength.
2. Viscosity
Importance: Viscosity affects the fluidity of gelatin during processing and the thickness of the capsule shell. The right viscosity ensures that the capsule shell is evenly formed and operated smoothly during production.
Screening criteria:
Capsule shell thickness requirements: Thicker capsule shells generally require higher viscosity, while thinner capsule shells require lower viscosity.
Process requirements: Select gelatin with moderate viscosity according to the production process (such as molding speed, mold design, etc.) to ensure smooth production.
3. Moisture content
Importance: Moisture content affects the processing properties of gelatin, the elasticity of the capsule shell, and the stability of the finished product. Controlling the moisture content prevents the capsule shell from contracting or cracking during the drying process.
Screening criteria:
Drying conditions: According to the drying conditions of the production line (such as temperature, humidity control ability), select the appropriate moisture content of gelatin, usually between 10-15%.
Product characteristics: For products that require a long shelf life or are sensitive to ambient humidity, choose gelatin with lower moisture content to improve storage stability.
4. Ash
Importance: The ash content reflects the level of mineral residues and impurities in the gelatin. The low ash content helps to improve the transparency and appearance quality of the capsule.
Screening criteria:
Appearance requirements: For products with high transparency or high color uniformity requirements, choose gelatin with ash content of less than 2%.
Safety: To ensure that the ash content is lower than the standard requirements to ensure the safety and quality of the product.
5. pH value
Importance: pH affects the stability of gelatin and its compatibility with fillers. Controlling the pH value within the appropriate range can avoid discoloration, degradation, or adverse reactions with the contents of the capsule shell.
Screening criteria:
Filling compatibility: Depending on the nature of the filling (such as acid and alkaline), choose a gelatin with a pH value in the range of 4.5-6.5 to ensure good compatibility between the capsule shell and the filling.
Stability requirements: For acid-base sensitive products, the pH value should be strictly controlled within the appropriate range to avoid deterioration of the capsule shell.
Step 6: Transparency
Importance: Transparent gelatin usually has fewer impurities and better quality, helping to produce a good looking softgel.
Screening criteria:
Appearance requirements: For products with high transparency requirements, choose gelatin with higher transparency.
Type of application: If the product requires a specific appearance (such as clear capsules), high transparency gelatin should be preferred.
7. Heavy metal content
Importance: Heavy metal content is controlled to ensure the safety of gelatin. Excessive levels of heavy metals may pose health risks.
Screening criteria:
Regulatory requirements: Comply with relevant regulations to ensure that heavy metal levels are below the prescribed standards (usually no more than 50 ppm).
Product safety: For products with high safety requirements (such as medicinal capsules), choose gelatin with very low heavy metal content.
8. Microbiological indicators
Importance: Microbiological control ensures the hygiene and safety of gelatin and avoids contamination resulting in unqualified or harmful products.
Screening criteria:
Production environment: According to the hygiene level of the production environment, select the gelatin that meets the microbial control standards.
Product use: For soft capsules for medical purposes, gelatin with strict control of microbial content should be selected to ensure compliance with pharmacopoeia standards.
A summary of the performance indexes of screening gelatin
For product characteristics: According to the specific use and appearance requirements of soft capsules, priority is given to the performance indicators that have the greatest impact, such as Bloom value, viscosity and moisture content.
Combined with process conditions: Considering the capacity of the production process and equipment conditions, select the appropriate gelatin performance indicators to ensure smooth production and consistent quality of the finished product.
Compliance with regulations and standards: Ensure that the selected gelatin complies with relevant regulations and standards, especially for medicinal softgel capsules, which must strictly comply with pharmacopoeia regulations.
Through the comprehensive screening of these key performance indicators, the quality of softgel can be effectively improved, the problems in production can be reduced, and the performance and stability of the final product can be ensured.