Tag: pharmaceutical validation

Poor validation of compressed air systems for particulate contamination.

April 3, 2025 Admin

Poor validation of compressed air systems for particulate contamination. Poor validation of compressed air systems for particulate contamination. Introduction: In the pharmaceutical industry, maintaining the integrity and purity of solid oral dosage forms such as hard and soft gelatin capsules is paramount. Compressed air systems play a critical role in various stages of pharmaceutical manufacturing,…

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

Problems with validating capsule sealing for capsules with delayed-release profiles.

April 3, 2025 Admin

Problems with validating capsule sealing for capsules with delayed-release profiles. Problems with Validating Capsule Sealing for Capsules with Delayed-Release Profiles Introduction: In the pharmaceutical industry, the demand for delayed-release capsules has been on the rise due to their ability to deliver active ingredients at specific sites within the gastrointestinal tract. These capsules are crucial for…

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

Problems with ensuring consistent gelatin plasticizer levels during validation.

April 2, 2025 Admin

Problems with ensuring consistent gelatin plasticizer levels during validation. Problems with Ensuring Consistent Gelatin Plasticizer Levels During Validation Introduction: The pharmaceutical industry faces numerous challenges when it comes to the formulation and validation of solid oral dosage forms, particularly capsules. Among these challenges, ensuring consistent gelatin plasticizer levels is critical in maintaining the quality and…

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

Difficulty in validating capsule drying processes for dual-layer capsules.

April 2, 2025 Admin

Difficulty in validating capsule drying processes for dual-layer capsules. Difficulty in validating capsule drying processes for dual-layer capsules Introduction: The pharmaceutical industry is constantly evolving, with innovations aimed at improving drug delivery systems and enhancing patient compliance. One such innovation is the development of dual-layer capsules. These capsules offer the advantage of delivering multiple drugs…

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

Difficulty in validating capsule drying processes for thermosensitive APIs.

April 1, 2025 Admin

Difficulty in validating capsule drying processes for thermosensitive APIs. Difficulty in validating capsule drying processes for thermosensitive APIs Introduction: In the realm of pharmaceutical manufacturing, ensuring the stability and efficacy of Active Pharmaceutical Ingredients (APIs) is paramount. Thermosensitive APIs, which are prone to degradation at elevated temperatures, pose unique challenges. As capsules, especially hard and…

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

Challenges in achieving consistent gelatin solution spread during validation.

April 1, 2025 Admin

Challenges in achieving consistent gelatin solution spread during validation. Challenges in achieving consistent gelatin solution spread during validation Introduction: In the realm of pharmaceutical manufacturing, ensuring the consistency of gelatin solution spread during the validation phase of capsule production is critical. Gelatin, being a key component in both hard and soft capsules, plays a vital…

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

Poor validation of water purification systems for high-demand operations.

March 25, 2025 Admin

Poor validation of water purification systems for high-demand operations. Poor validation of water purification systems for high-demand operations. Introduction: Water purification systems are integral to pharmaceutical manufacturing, especially in the production of solid oral dosage forms like capsules. The quality of water used directly impacts the safety and efficacy of oral medications. However, poor validation…

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

Problems with ensuring consistent alignment of capsule cap and body parts during validation.

March 21, 2025 Admin

Problems with ensuring consistent alignment of capsule cap and body parts during validation. Problems with ensuring consistent alignment of capsule cap and body parts during validation. Introduction: In the pharmaceutical industry, the production of solid oral dosage forms such as capsules requires precision and adherence to stringent quality standards. Capsules, particularly hard and soft gelatin…

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

Difficulty in validating capsule filling equipment for lipid-based suspensions.

March 20, 2025 Admin

Difficulty in validating capsule filling equipment for lipid-based suspensions. Difficulty in validating capsule filling equipment for lipid-based suspensions. Introduction: In the pharmaceutical industry, the encapsulation of lipid-based suspensions presents unique challenges that require meticulous validation of capsule filling equipment. Lipid-based formulations are gaining popularity due to their ability to enhance the bioavailability of poorly water-soluble…

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

Challenges in validating backup utility systems for capsule manufacturing.

March 19, 2025 Admin

Challenges in validating backup utility systems for capsule manufacturing. Challenges in validating backup utility systems for capsule manufacturing. Introduction: In the intricate field of pharmaceutical manufacturing, ensuring the uninterrupted operation of utility systems is crucial, particularly in the production of solid oral dosage forms like capsules. The reliability of backup utility systems, including power, HVAC,…

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

Poor validation of capsule disintegration testing for gelatin-free capsules.

March 17, 2025 Admin

Poor validation of capsule disintegration testing for gelatin-free capsules. Poor validation of capsule disintegration testing for gelatin-free capsules. Introduction: In the pharmaceutical industry, ensuring the efficacy and safety of oral dosage forms is paramount. Capsules, both hard and soft gelatin, have been widely used due to their ability to encapsulate a variety of formulations. However,…

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

Poor reproducibility in recovery rates for rinse sampling validation.

March 15, 2025 Admin

Poor reproducibility in recovery rates for rinse sampling validation. Poor reproducibility in recovery rates for rinse sampling validation. Introduction: In the pharmaceutical industry, maintaining rigorous standards for cleanliness and contamination control is paramount. Rinse sampling validation is a critical component of this process, ensuring that manufacturing equipment is adequately cleaned between batches. However, achieving consistent…

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