Production Facilities and Controls requires specially designed cleanrooms, HEPA-filtered air systems, and restricted personnel access to maintain aseptic conditions. Production Facilities and Controls also include rigorous environmental monitoring, validated sterilization processes, and regular maintenance of sterile equipment. Production Facilities: Clean Rooms: Controlled environments with regulated temperature, humidity, and particulate levels to prevent contamination. Laminar Air … Read more

Vehicles, Additives, and Importance of Isotonicity play a crucial role in pharmaceutical formulations by ensuring drug solubility, stability, and patient acceptability. Vehicles and Additives also help maintain osmotic balance to prevent irritation or tissue damage. Vehicles The medium in which the drug is dissolved or suspended. Common vehicles include: Water for Injection (WFI): Highly purified … Read more

Introduction to Pellets Pellets are small, free-flowing, spherical or semi-spherical solid dosage forms ranging in size from 0.5 mm to 2.0 mm. They are primarily used in the pharmaceutical industry to deliver active pharmaceutical ingredients (APIs) and exhibit excellent uniformity, flowability, and versatility. Key Features: Shape and Size: Typically spherical, though slightly oval or irregular … Read more

Definition of Parenteral Products Parenteral Products refer to pharmaceutical preparations intended for administration by routes that bypass the digestive system, primarily through injections. This includes: Intravenous (IV): Directly into a vein. Intramuscular (IM): Into a muscle. Subcutaneous (SC): Under the skin. Intradermal (ID): Into the dermis layer of the skin. Other Routes: Such as epidural, … Read more

Filling and Sealing of Ampoules, Vials, and Infusion Fluids ensure sterility and accurate dosing by using automated systems under aseptic conditions. Filling and Sealing of Ampoules are critical for patient safety and product stability. Ampoules: Washing and Sterilization Ampoules are washed (automatically or manually), depyrogenated (typically by dry heat in a depyrogenation tunnel), and transferred to … Read more

Formulation Requirements for Pellets include ensuring uniform particle size, appropriate flowability, compressibility, for optimal processing and performance. Formulation Requirements for Pellets also involve maintaining drug stability, controlling moisture content, and achieving desired drug release profiles through suitable polymers and excipients. The formulation of pellets involves careful selection of ingredients to ensure proper drug release, stability, … Read more

Packing, Storage, and Stability Testing ensure drug protection by using suitable containers and environmental controls to preserve efficacy and safety. Packing, Storage, and Stability Testing help determine a product’s shelf life by assessing its physical, chemical, and microbiological stability under various conditions. Packing: Soft gelatin capsules are packed in moisture-proof containers to prevent degradation. Common … Read more