Tag: USFDA guidelines

Ensuring Adequacy of Humidity Control Systems for Sugar-Coated Tablet Areas

March 18, 2025 Admin

Ensuring Adequacy of Humidity Control Systems for Sugar-Coated Tablet Areas Ensuring Adequacy of Humidity Control Systems for Sugar-Coated Tablet Areas Introduction: In the pharmaceutical industry, maintaining precise environmental conditions is crucial for the manufacturing of high-quality products. Specifically, the production of sugar-coated tablets requires stringent humidity control to ensure the integrity and efficacy of the…

Solid Dosage form, Tablets

Troubleshooting Weight Variation in High-Speed Compression Lines

March 18, 2025 Admin

Troubleshooting Weight Variation in High-Speed Compression Lines Troubleshooting Weight Variation in High-Speed Compression Lines Introduction: The pharmaceutical industry is continually evolving, with high-speed compression lines playing a pivotal role in the manufacturing of solid dosage forms like tablets. Ensuring consistent weight across tablets is crucial not only for dosage accuracy but also for regulatory compliance…

Solid Dosage form, Tablets

Avoiding Over-Sensitivity to Moisture in Hygroscopic Tablets

March 18, 2025 Admin

Avoiding Over-Sensitivity to Moisture in Hygroscopic Tablets Avoiding Over-Sensitivity to Moisture in Hygroscopic Tablets Introduction: In the world of pharmaceuticals, the stability and efficacy of tablets are of utmost importance. Hygroscopic tablets, which have a tendency to absorb moisture from the environment, pose unique challenges in maintaining their integrity and functionality. Moisture sensitivity can lead…

Solid Dosage form, Tablets

Managing Fines Generation During Compression of Immediate Release Tablets

March 17, 2025 Admin

Managing Fines Generation During Compression of Immediate Release Tablets Managing Fines Generation During Compression of Immediate Release Tablets Introduction: In the pharmaceutical industry, the production of immediate-release tablets is a crucial process that requires meticulous attention to detail. One of the significant challenges faced during the tablet manufacturing process is the generation of fines. Fines…

Solid Dosage form, Tablets

Preventing Layer Cracking in Multi-Layer Tablets During Storage

March 17, 2025 Admin

Preventing Layer Cracking in Multi-Layer Tablets During Storage Preventing Layer Cracking in Multi-Layer Tablets During Storage Introduction: Multi-layer tablets are an increasingly popular pharmaceutical dosage form due to their ability to deliver multiple active ingredients with different release profiles in a single dosage unit. Despite their benefits, these tablets are susceptible to layer cracking during…

Solid Dosage form, Tablets

Managing Calibration Failures in Humidity Sensors for Cleanrooms

March 17, 2025 Admin

Managing Calibration Failures in Humidity Sensors for Cleanrooms Managing Calibration Failures in Humidity Sensors for Cleanrooms Introduction: In the pharmaceutical industry, maintaining precise environmental conditions is crucial for ensuring product quality and compliance with Good Manufacturing Practice (GMP) standards. Cleanrooms, which are controlled environments with low levels of pollutants, play a vital role in pharmaceutical…

Solid Dosage form, Tablets

Ensuring Consistency in Rinse Water Sampling for Cleaning Validation

March 17, 2025 Admin

Ensuring Consistency in Rinse Water Sampling for Cleaning Validation Ensuring Consistency in Rinse Water Sampling for Cleaning Validation Introduction: In the pharmaceutical industry, maintaining the highest standards of cleanliness is crucial for ensuring product safety and efficacy. Cleaning validation, particularly rinse water sampling, plays a significant role in verifying that manufacturing equipment is free from…

Solid Dosage form, Tablets

Troubleshooting Uneven Color Distribution in Sugar-Coated Tablets

March 17, 2025 Admin

Troubleshooting Uneven Color Distribution in Sugar-Coated Tablets Troubleshooting Uneven Color Distribution in Sugar-Coated Tablets Introduction: Sugar-coated tablets are a popular dosage form in the pharmaceutical industry due to their ability to mask unpleasant tastes and improve patient compliance. However, achieving a uniform color distribution on these tablets can be challenging. Uneven color distribution not only…

Solid Dosage form, Tablets

Difficulty in maintaining accurate logs for temperature and humidity controls.

March 17, 2025 Admin

Difficulty in maintaining accurate logs for temperature and humidity controls. Difficulty in Maintaining Accurate Logs for Temperature and Humidity Controls Introduction: In the pharmaceutical industry, maintaining precise environmental controls is crucial, especially for solid oral dosage forms like capsules. Both hard and soft gelatin capsules are sensitive to temperature and humidity fluctuations, which can affect…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Difficulty in maintaining uniform gelatin solution pH.

March 16, 2025 Admin

Difficulty in maintaining uniform gelatin solution pH. Difficulty in Maintaining Uniform Gelatin Solution pH Introduction: In the pharmaceutical industry, maintaining the uniformity of gelatin solution pH is crucial for the production of high-quality hard and soft gelatin capsules. These capsules are widely used due to their ease of administration and ability to mask unpleasant tastes…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Preventing Adhesion Failures in Multi-Layer Tablet Compression

March 16, 2025 Admin

Preventing Adhesion Failures in Multi-Layer Tablet Compression Preventing Adhesion Failures in Multi-Layer Tablet Compression Introduction: In the pharmaceutical industry, the production of multi-layer tablets has become increasingly popular due to their ability to deliver multiple drugs or release profiles simultaneously. However, one of the significant challenges faced during the manufacturing process is adhesion failure between…

Solid Dosage form, Tablets

Managing Calibration Failures in Steam Quality Sensors for Coating Equipment

March 16, 2025 Admin

Managing Calibration Failures in Steam Quality Sensors for Coating Equipment Managing Calibration Failures in Steam Quality Sensors for Coating Equipment Introduction: In the pharmaceutical industry, maintaining the quality and efficiency of coating equipment is crucial for ensuring the final product’s efficacy and safety. Steam quality sensors play a pivotal role in this process, as they…

Solid Dosage form, Tablets