Tag: Risk management

Troubleshooting Failures in Residual Solvent Control for Compressed Air Systems

March 7, 2025 Admin

Troubleshooting Failures in Residual Solvent Control for Compressed Air Systems Troubleshooting Failures in Residual Solvent Control for Compressed Air Systems Introduction: In the pharmaceutical industry, maintaining the purity of compressed air systems is critical for ensuring the safety and efficacy of solid dosage forms such as tablets. Residual solvent control plays a vital role in…

Solid Dosage form, Tablets

Ensuring Compliance with Clean Steam Standards in Multi-Product Facilities

March 7, 2025 Admin

Ensuring Compliance with Clean Steam Standards in Multi-Product Facilities Ensuring Compliance with Clean Steam Standards in Multi-Product Facilities Introduction: In the dynamic landscape of pharmaceutical manufacturing, ensuring compliance with clean steam standards is critical, particularly in multi-product facilities. Clean steam is crucial for maintaining the sterility and quality of pharmaceutical products. It is used in…

Solid Dosage form, Tablets

Addressing Cross-Contamination Risks in Purified Water Systems for Multi-API Tablets

March 5, 2025 Admin

Addressing Cross-Contamination Risks in Purified Water Systems for Multi-API Tablets Addressing Cross-Contamination Risks in Purified Water Systems for Multi-API Tablets Introduction: In the pharmaceutical industry, the production of multi-Active Pharmaceutical Ingredient (API) tablets poses unique challenges, particularly concerning cross-contamination. Purified water systems play a pivotal role in tablet manufacturing, serving as a critical utility in…

Solid Dosage form, Tablets

Validating Rinse Sampling Protocols for Cleaning Validation in Multi-Product Facilities

March 5, 2025 Admin

Validating Rinse Sampling Protocols for Cleaning Validation in Multi-Product Facilities Validating Rinse Sampling Protocols for Cleaning Validation in Multi-Product Facilities Introduction: In the dynamic field of pharmaceutical manufacturing, maintaining stringent hygiene and safety standards is paramount. Multi-product facilities, which handle the production of various drugs using shared equipment, face unique challenges in preventing cross-contamination. A…

Solid Dosage form, Tablets

Inadequate validation protocols for new capsule formulations.

March 4, 2025 Admin

Inadequate validation protocols for new capsule formulations. Inadequate Validation Protocols for New Capsule Formulations Introduction: The pharmaceutical industry is continually evolving, with innovations leading to new and effective drug delivery systems. Among these, capsules remain a popular choice due to their ease of administration and ability to encapsulate a wide range of drug compounds. However,…

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

Ensuring Robustness in Purified Water Flow Rates for Cleaning Validation

March 4, 2025 Admin

Ensuring Robustness in Purified Water Flow Rates for Cleaning Validation Ensuring Robustness in Purified Water Flow Rates for Cleaning Validation Introduction: In the pharmaceutical industry, maintaining high standards of cleanliness and sanitation is paramount. One critical component of this process is the use of purified water for cleaning validation. The flow rate of purified water…

Solid Dosage form, Tablets

Ensuring Robustness in Cleaning Validation for Granulators Used with Low-Dose APIs

March 4, 2025 Admin

Ensuring Robustness in Cleaning Validation for Granulators Used with Low-Dose APIs Ensuring Robustness in Cleaning Validation for Granulators Used with Low-Dose APIs Introduction: In the pharmaceutical industry, ensuring the cleanliness and safety of manufacturing equipment is crucial, especially when dealing with low-dose Active Pharmaceutical Ingredients (APIs). Granulators, essential in the tablet production process, must undergo…

Solid Dosage form, Tablets

Challenges in implementing robust quality controls for capsule packaging processes.

March 4, 2025 Admin

Challenges in implementing robust quality controls for capsule packaging processes. Challenges in implementing robust quality controls for capsule packaging processes. Introduction: The pharmaceutical industry prioritizes patient safety and product efficacy, making quality control a critical component of the manufacturing process. Capsules, both hard and soft gelatin, are among the most common solid oral dosage forms….

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

Validating Temperature Mapping in Cleanrooms for Sustained Release Tablets

March 4, 2025 Admin

Validating Temperature Mapping in Cleanrooms for Sustained Release Tablets Validating Temperature Mapping in Cleanrooms for Sustained Release Tablets Introduction: In the pharmaceutical industry, maintaining the integrity of sustained release tablets during production is vital to ensure efficacy and safety. A critical step in this process is validating temperature mapping in cleanrooms, where these tablets are…

Solid Dosage form, Tablets

Managing Cross-Contamination Risks in Fluid Bed Granulators for Multi-Layer Tablets

March 4, 2025 Admin

Managing Cross-Contamination Risks in Fluid Bed Granulators for Multi-Layer Tablets Managing Cross-Contamination Risks in Fluid Bed Granulators for Multi-Layer Tablets Introduction: In the pharmaceutical industry, the production of multi-layer tablets requires meticulous attention to detail to ensure product safety and efficacy. One critical aspect of tablet production is the use of fluid bed granulators, which…

Solid Dosage form, Tablets

Challenges in validating equipment used for delayed-release capsule coating.

March 3, 2025 Admin

Challenges in validating equipment used for delayed-release capsule coating. Challenges in validating equipment used for delayed-release capsule coating. Introduction: In the pharmaceutical industry, delayed-release capsule coating is crucial for ensuring that active ingredients are released at the right time and location within the gastrointestinal tract. This technology enhances therapeutic efficacy, minimizes side effects, and improves…

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

Poor reproducibility in validation results for air filtration systems.

March 3, 2025 Admin

Poor reproducibility in validation results for air filtration systems. Poor reproducibility in validation results for air filtration systems. Introduction: In the pharmaceutical industry, air filtration systems are crucial for maintaining cleanroom standards and ensuring the quality and safety of products, especially in the manufacturing of solid oral dosage forms like capsules. These systems are designed…

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