Tag: USFDA guidelines

Managing Packing Material Variation for Consistency in Blister Packaging

Posted on By Admin

Managing Packing Material Variation for Consistency in Blister Packaging Managing Packing Material Variation for Consistency in Blister Packaging Introduction: In the pharmaceutical industry, blister packaging serves as a critical component for ensuring the stability and protection of solid dosage forms like tablets. The packaging not only safeguards the medication but also ensures patient compliance and…

Read More “Managing Packing Material Variation for Consistency in Blister Packaging” »

Solid Dosage form, Tablets

Addressing Challenges in Handling Enteric-Coated Tablets During Blister Packing

Posted on By Admin

Addressing Challenges in Handling Enteric-Coated Tablets During Blister Packing Addressing Challenges in Handling Enteric-Coated Tablets During Blister Packing Introduction: Enteric-coated tablets are designed to withstand the acidic environment of the stomach and dissolve in the alkaline environment of the intestine. This specialized coating is crucial for the targeted delivery of certain medications, ensuring their efficacy…

Read More “Addressing Challenges in Handling Enteric-Coated Tablets During Blister Packing” »

Solid Dosage form, Tablets

Troubleshooting Over-Lubrication in Powder Blends During Compression Validation

Posted on By Admin

Troubleshooting Over-Lubrication in Powder Blends During Compression Validation Troubleshooting Over-Lubrication in Powder Blends During Compression Validation Introduction: In the pharmaceutical industry, the production of tablets is a complex process that demands precision and careful attention to detail. One critical aspect of tablet manufacturing is the lubrication of powder blends, which facilitates the tablet compression process….

Read More “Troubleshooting Over-Lubrication in Powder Blends During Compression Validation” »

Solid Dosage form, Tablets

Managing Residue Build-Up in Spray Guns for Coating Equipment Cleaning Validation

Posted on By Admin

Managing Residue Build-Up in Spray Guns for Coating Equipment Cleaning Validation Managing Residue Build-Up in Spray Guns for Coating Equipment Cleaning Validation Introduction: In the pharmaceutical industry, maintaining the integrity of coating equipment is vital for ensuring product quality and regulatory compliance. Spray guns, integral to the coating process, often face challenges related to residue…

Read More “Managing Residue Build-Up in Spray Guns for Coating Equipment Cleaning Validation” »

Solid Dosage form, Tablets

Investigating Impact of Humidity on Coating Integrity in Film-Coated Tablets

Posted on By Admin

Investigating Impact of Humidity on Coating Integrity in Film-Coated Tablets Investigating Impact of Humidity on Coating Integrity in Film-Coated Tablets Introduction: In the pharmaceutical industry, ensuring the integrity of film-coated tablets is a critical aspect of product quality and efficacy. Film coatings on tablets serve multiple purposes, including protection from environmental factors, masking unpleasant tastes,…

Read More “Investigating Impact of Humidity on Coating Integrity in Film-Coated Tablets” »

Solid Dosage form, Tablets

Ensuring Accuracy in Compression Force Sensors During Tablet Press Validation

Posted on By Admin

Ensuring Accuracy in Compression Force Sensors During Tablet Press Validation Ensuring Accuracy in Compression Force Sensors During Tablet Press Validation Introduction: In the pharmaceutical industry, precision in tablet manufacturing is paramount. Ensuring the accuracy of compression force sensors during tablet press validation is critical for maintaining the quality and uniformity of tablets. These sensors play…

Read More “Ensuring Accuracy in Compression Force Sensors During Tablet Press Validation” »

Solid Dosage form, Tablets

Validating Cleaning Protocols for High-Speed Compression Lines

Posted on By Admin

Validating Cleaning Protocols for High-Speed Compression Lines Validating Cleaning Protocols for High-Speed Compression Lines Introduction: In the pharmaceutical industry, ensuring the cleanliness of equipment used in tablet production is crucial for maintaining product quality and safety. High-speed compression lines are integral to the efficient production of tablets, but they also pose significant challenges when it…

Read More “Validating Cleaning Protocols for High-Speed Compression Lines” »

Solid Dosage form, Tablets

Validating Airborne Particle Monitoring Systems in Cleanrooms

Posted on By Admin

Validating Airborne Particle Monitoring Systems in Cleanrooms Validating Airborne Particle Monitoring Systems in Cleanrooms Introduction: In pharmaceutical manufacturing, the integrity of cleanrooms is paramount to ensuring product safety and efficacy. Airborne particle monitoring systems are critical components of cleanroom environments, as they ensure that the levels of particulate matter remain within acceptable limits. These systems…

Read More “Validating Airborne Particle Monitoring Systems in Cleanrooms” »

Solid Dosage form, Tablets

Validating Water for Injection (WFI) Systems in Multi-Product Facilities

Posted on By Admin

Validating Water for Injection (WFI) Systems in Multi-Product Facilities Validating Water for Injection (WFI) Systems in Multi-Product Facilities Introduction: Water for Injection (WFI) is a critical component in pharmaceutical manufacturing, particularly in multi-product facilities where diverse formulations are produced. WFI is used for dissolving or diluting substances or preparations during production, ensuring sterility and non-pyrogenicity….

Read More “Validating Water for Injection (WFI) Systems in Multi-Product Facilities” »

Solid Dosage form, Tablets

Addressing Punch Wear Issues During Tablet Press Validation

Posted on By Admin

Addressing Punch Wear Issues During Tablet Press Validation Addressing Punch Wear Issues During Tablet Press Validation Introduction: In the pharmaceutical manufacturing sector, ensuring the integrity and quality of tablet products is paramount. One critical aspect of this process is the validation of tablet presses, where punch wear can significantly impact product quality and efficiency. Punches,…

Read More “Addressing Punch Wear Issues During Tablet Press Validation” »

Solid Dosage form, Tablets

Troubleshooting Powder Segregation Issues During Validation of Compression Lines

Posted on By Admin

Troubleshooting Powder Segregation Issues During Validation of Compression Lines Troubleshooting Powder Segregation Issues During Validation of Compression Lines Introduction: In the realm of pharmaceutical manufacturing, maintaining the uniformity and consistency of solid dosage forms, such as tablets, is crucial. One of the common challenges faced during the validation of compression lines is powder segregation. This…

Read More “Troubleshooting Powder Segregation Issues During Validation of Compression Lines” »

Solid Dosage form, Tablets

Addressing Powder Bridging Issues in Tablet Press Feed Systems During Validation

Posted on By Admin

Addressing Powder Bridging Issues in Tablet Press Feed Systems During Validation Addressing Powder Bridging Issues in Tablet Press Feed Systems During Validation Introduction: In the pharmaceutical industry, ensuring the consistent production of high-quality tablets is paramount. The tablet press feed system plays a crucial role in this process by delivering a uniform and precise amount…

Read More “Addressing Powder Bridging Issues in Tablet Press Feed Systems During Validation” »

Solid Dosage form, Tablets