Tag: pharmaceutical validation

Troubleshooting Layer Cracks in Bilayer Tablets During Validation

March 15, 2025 Admin

Troubleshooting Layer Cracks in Bilayer Tablets During Validation Troubleshooting Layer Cracks in Bilayer Tablets During Validation Introduction: Bilayer tablets have gained significant traction in the pharmaceutical industry due to their ability to deliver multiple drugs with distinct release profiles in a single dosage form. However, during the manufacturing process, these tablets can present unique challenges,…

Solid Dosage form, Tablets

Troubleshooting Residual Binder Issues in Granulation Equipment During Validation

March 14, 2025 Admin

Troubleshooting Residual Binder Issues in Granulation Equipment During Validation Troubleshooting Residual Binder Issues in Granulation Equipment During Validation Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of solid dosage forms like tablets is paramount. Granulation is a critical process in tablet manufacturing, where powders are agglomerated to form granules, enhancing flowability and compressibility…

Solid Dosage form, Tablets

Inadequate validation of capsule printing processes for accuracy.

March 14, 2025 Admin

Inadequate validation of capsule printing processes for accuracy. Inadequate Validation of Capsule Printing Processes for Accuracy Introduction: In the pharmaceutical industry, capsule printing serves as a critical aspect of product identification, branding, and prevention of medication errors. Ensuring the accuracy of capsule printing is essential not only for maintaining brand integrity but also for safeguarding…

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

Poor reproducibility in validation data for semi-automated encapsulation systems.

March 13, 2025 Admin

Poor reproducibility in validation data for semi-automated encapsulation systems. Poor reproducibility in validation data for semi-automated encapsulation systems. Introduction: In the pharmaceutical industry, the precision and consistency of encapsulation systems, particularly semi-automated ones, are paramount. Encapsulation plays a vital role in drug delivery, ensuring each dose contains the correct amount of active pharmaceutical ingredient (API)….

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

Troubleshooting Residual Powder Issues in Tablet Compression Equipment During Validation

March 10, 2025 Admin

Troubleshooting Residual Powder Issues in Tablet Compression Equipment During Validation Troubleshooting Residual Powder Issues in Tablet Compression Equipment During Validation Introduction: The pharmaceutical industry is continuously evolving, with tablet manufacturing playing a crucial role in the delivery of medications. One of the significant challenges faced during the tablet compression process is the issue of residual…

Solid Dosage form, Tablets

Addressing Heat Sensitivity of APIs During Validation of Coated Tablets

March 10, 2025 Admin

Addressing Heat Sensitivity of APIs During Validation of Coated Tablets Addressing Heat Sensitivity of APIs During Validation of Coated Tablets Introduction: The pharmaceutical industry continuously strives to enhance the efficacy, stability, and safety of drug products. One of the critical aspects of drug formulation is the management of active pharmaceutical ingredients (APIs) that exhibit sensitivity…

Solid Dosage form, Tablets

Poor validation of capsule weight variation for oil-based fills.

March 10, 2025 Admin

Poor validation of capsule weight variation for oil-based fills. Poor validation of capsule weight variation for oil-based fills Introduction: In the pharmaceutical industry, the production of capsules, especially those containing oil-based fills, presents unique challenges. Capsules are a preferred solid oral dosage form due to their versatility and ability to deliver precise doses of medication….

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

Poor recovery of residues in rinse sampling during validation.

March 9, 2025 Admin

Poor recovery of residues in rinse sampling during validation. Poor recovery of residues in rinse sampling during validation. Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is paramount. One of the critical aspects of cleaning validation is rinse sampling, which helps ensure that no residue from previous manufacturing processes remains on the…

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

Challenges in validating nitrogen distribution systems for soft capsule drying.

March 8, 2025 Admin

Challenges in validating nitrogen distribution systems for soft capsule drying. Challenges in validating nitrogen distribution systems for soft capsule drying. Introduction: In the pharmaceutical industry, the production of soft gelatin capsules is a complex process that requires precise conditions to ensure product quality and efficacy. One critical aspect of this process is the drying phase,…

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

Validating Adequacy of Binder Concentration in Wet Granulation Processes

March 8, 2025 Admin

Validating Adequacy of Binder Concentration in Wet Granulation Processes Validating Adequacy of Binder Concentration in Wet Granulation Processes Introduction: In the realm of pharmaceutical manufacturing, the wet granulation process is a cornerstone for producing high-quality tablets. Ensuring the adequacy of binder concentration is critical in this process, as it directly influences the tablet’s integrity, dissolution…

Solid Dosage form, Tablets

Difficulty in validating capsule sealing for capsules with multi-layer fills.

March 8, 2025 Admin

Difficulty in validating capsule sealing for capsules with multi-layer fills. Difficulty in validating capsule sealing for capsules with multi-layer fills Introduction: Capsules have long been a preferred dosage form in the pharmaceutical industry due to their versatility and convenience. The advent of multi-layer fills in capsules has paved the way for innovative drug delivery systems….

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

Difficulty in validating capsule filling for lipid-based formulations.

March 8, 2025 Admin

Difficulty in validating capsule filling for lipid-based formulations. Difficulty in Validating Capsule Filling for Lipid-Based Formulations Introduction: Lipid-based formulations have gained significant attention in the pharmaceutical industry due to their potential to improve the bioavailability of poorly soluble drugs. As a result, encapsulating these formulations, particularly in hard or soft gelatin capsules, has become increasingly…

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