Tag: Capsule Manufacturing

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

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

Challenges in maintaining proper environmental conditions in production areas.

March 7, 2025 Admin

Challenges in maintaining proper environmental conditions in production areas. Challenges in maintaining proper environmental conditions in production areas. Introduction: The pharmaceutical industry is highly regulated, with stringent requirements for maintaining optimal environmental conditions in production areas. This is particularly critical for the manufacturing of capsules, both hard and soft gelatin, where environmental control can significantly…

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

Difficulty in validating cleaning methods for enteric-coated formulations.

March 7, 2025 Admin

Difficulty in validating cleaning methods for enteric-coated formulations. Difficulty in Validating Cleaning Methods for Enteric-Coated Formulations Introduction: In the pharmaceutical industry, maintaining stringent cleanliness standards is crucial to ensure product safety and efficacy. One area that presents significant challenges is the cleaning validation for enteric-coated formulations. These formulations are designed to resist the acidic environment…

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

Difficulty in testing for capsule tamper resistance.

March 7, 2025 Admin

Difficulty in testing for capsule tamper resistance. Difficulty in Testing for Capsule Tamper Resistance Introduction: In the pharmaceutical industry, ensuring the integrity and safety of drug products is paramount. Capsules, both hard and soft gelatin, are popular solid oral dosage forms due to their convenience and efficiency in delivering medication. However, they are vulnerable to…

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

Difficulty in testing gelatin-free capsules for uniformity.

March 7, 2025 Admin

Difficulty in testing gelatin-free capsules for uniformity. Difficulty in Testing Gelatin-Free Capsules for Uniformity Introduction: In the evolving landscape of pharmaceutical formulations, gelatin-free capsules have emerged as a significant advancement, especially for those seeking vegetarian or vegan alternatives. These capsules not only cater to dietary preferences but also overcome some of the limitations associated with…

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

Challenges in ensuring proper alignment of capsule packs in cartons.

March 7, 2025 Admin

Challenges in ensuring proper alignment of capsule packs in cartons. Challenges in ensuring proper alignment of capsule packs in cartons. Introduction: Proper alignment of capsule packs in cartons is a critical component in pharmaceutical manufacturing and packaging. This process is crucial to ensure product integrity, safety, and compliance with stringent industry regulations. Ensuring that capsule…

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

Problems with ensuring consistent air velocity in encapsulation areas.

March 7, 2025 Admin

Problems with ensuring consistent air velocity in encapsulation areas. Problems with ensuring consistent air velocity in encapsulation areas. Introduction: In the pharmaceutical industry, maintaining a controlled environment in encapsulation areas is crucial for product quality and compliance. Consistent air velocity is a key parameter in these controlled environments, ensuring that the air is properly filtered…

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

Problems with validating capsule weight variation for hard gelatin capsules.

March 7, 2025 Admin

Problems with validating capsule weight variation for hard gelatin capsules. Problems with validating capsule weight variation for hard gelatin capsules. Introduction: In the pharmaceutical industry, hard gelatin capsules are a prevalent form of solid oral dosage. Ensuring the consistency of capsule weight is crucial for maintaining dosage accuracy, therapeutic efficacy, and patient safety. Variations in…

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

Poor reproducibility in monitoring capsule disintegration profiles.

March 6, 2025 Admin

Poor reproducibility in monitoring capsule disintegration profiles. Poor reproducibility in monitoring capsule disintegration profiles. Introduction: The disintegration profile of capsules is a critical quality attribute that significantly impacts the bioavailability and therapeutic efficacy of the drug product. Ensuring consistent and reproducible disintegration times is essential for achieving regulatory compliance and maintaining product quality. Despite its…

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

Inadequate methods for monitoring capsule brittleness under low humidity conditions.

March 6, 2025 Admin

Inadequate methods for monitoring capsule brittleness under low humidity conditions. Inadequate Methods for Monitoring Capsule Brittleness Under Low Humidity Conditions Introduction: Capsules, both hard and soft gelatin, are a prevalent form of solid oral dosage forms in the pharmaceutical industry. Ensuring their integrity and efficacy is crucial for therapeutic effectiveness. One of the significant challenges…

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