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Large Volume Parenteral (LVP) Solutions and Sterile Filtration

The term “Large Volume Parenteral” (LVP) solutions is the FDA’s accepted terminology for intravenous (IV) solutions. LVPs or IV solutions consist of sterile water or low-concentration solutions of saline, dextrose, carbohydrates, electrolytes, lipids, vitamins, and proteins, produced in batches of tens of thousands of liters. Filtration is essential for removing particles and colloids, reducing bioburden, and ensuring sterilization.

MEMSEP FILTRATION offers a comprehensive range of microfiltration cartridge and capsule filters for the sterile filtration of large volume parenterals. Additionally, validated hydrophobic PTFE cartridge filters are available for Blow-Fill-Seal (BFS), Form-Fill-Seal (FFS) lines, and sterile tank venting.

Importance of Sterile Filtration in API Production

Active Pharmaceutical Ingredients (APIs) used in sterile medicinal products must be sterile unless the final dosage form undergoes terminal sterilization or includes a sterilizing filtration step. Sterile APIs intended for parenteral products must meet relevant specifications on pyrogens or bacterial endotoxins. Consequently, the manufacture of sterile APIs must be strictly controlled to minimize the risk of contamination with microorganisms, endotoxins, and particles, making sterile filtration a critical process step.

MEMSEP FILTRATION provides validated sterilization-grade PTFE membrane cartridge filters with FEP-encapsulated viton ‘O’ rings, ensuring compatibility with a wide range of solvents used in these processes.

Applications in the Pharmaceutical Industry

• Active Pharmaceutical Ingredients (API) Manufacturing: Ensuring sterility in API production.
• Blood Plasma: Filtration for safe and pure blood plasma products.
• Injectable Preparations and Antibiotics: Sterile filtration for injectable drugs and penicillins.
• Fermentation Processes and Biotechnology: Ensuring contamination-free biotech and fermentation processes.
• Oral Liquids, Serums, Vaccines: Filtration for various liquid pharmaceutical products.
• Bioburden Monitoring: Tracking and reducing bioburden in production processes.
• Point-of-Use Filtration: Ensuring sterile filtration at the point of use.
• Clarification of High-Density Cell Cultures: Efficient filtration for cell culture applications.
• Ultra-Pure Water and Water for Injection (WFI): Providing pure water for pharmaceutical use.
• Cosmetics and Vitamin Production: Sterile filtration for the cosmetics and vitamin industries.
• Blood Banks: Ensuring the safety and purity of blood products.
• Veterinary Medicines: Sterile filtration for veterinary pharmaceutical products.
• Hospitals: Applications in dialysis, endoscopy, and other medical procedures.

MEMSEP FILTRATION is committed to providing high-quality filtration solutions tailored to the needs of the pharmaceutical industry, ensuring the highest standards of sterility and safety