logo

Large Volume Parenterals (LVP’s)

A single packet of large volumes of parenteral medications (LVP) contains more than 100 ml. Lot sizes typically range from 10,000 to more liters. In typical LVP solutions, water, glucose, salts, amino acids, and viscous components make up the bulk of the mixture. Prefiltration, which eliminates colloidal and mechanical contaminants, helps the final sterilizing filters last longer. Final filtration is to reduce bio-burden and sterilization.

Ask an expert

LVP (Large Volume Parenteral) is primarily administered intravenously to deliver a larger volume of liquid medication directly into a patient’s circulatory system via infusion. Common LVP solutions include saline and dextrose. In contrast, SVP (Small Volume Parenteral) is primarily utilized for intravenous or subcutaneous injections, particularly for treatments requiring smaller doses such as antibiotics and analgesics.

Sterile preparations exhibit a diverse composition with varying pH values, necessitating the removal of sugar, protein, pectin, and other particulates from the initial solution during the filtration process. Additionally, certain raw materials may contain asbestos fibers, imposing stringent sterilization criteria for terminal filtration. Sanitek Filter offers comprehensive filtration solutions to assist pharmaceutical industry clients in addressing their specific challenges.

Large Volume Parenterals (LVP’s)

Optimizing the LVP filtration process

Filtration Process Recommend Product Recommend Pore Size
Decarbonization and Filtration Ultrapure Series-PP 1~10um
Pre-filtration Ultrapure Series 1~10um
Redundant Filtration Stery Series 0.45~1um
Final sterilization filtration Stery Series 0.1~0.22um
Tank Vent filtration GasFlow Series 0.22~0.45um

Decarbonization and Filtration

In the pharmaceutical industry, pure water is indispensable for various processes. Decarbonization plays a crucial role in ensuring the purity of water by effectively reducing the levels of organic matter and microorganisms. By employing decarbonization techniques, pharmaceutical companies can uphold stringent quality standards and ensure that the water used in production meets regulatory requirements.Decarbonization can be performed using a lenticular filter.

Pre-filtration

Pre-filtration is a crucial step that removes gums, aggregates, non-target proteins, lipids, and other particles before downstream purification processes. This process not only enhances the efficiency of downstream sterilized filters or columns but also safeguards their integrity, ensuring optimal performance and purity throughout the purification process.

Redundant Filtration

Redundant filtration usually refers to the use of multiple identical or similar filtration units in a system or process to improve system reliability and fault tolerance. The purpose of redundant filtration is that in the event of failure of one or more filter units, the system will still be able to operate normally because other filter units can take over the work. Therefore, the service life of the filters should be a little bit longer so as to ensure its backup.

Final sterilization filtration

Usually, membranes with a pore size of 0.22μm or less are used as filtration materials. Some preparations can’t be sterilized by hot water or high temperature steam sterilization in the subsequent steps, at this time, the use of 0.22μm pore size filters will not cause damage to the raw materials, but also to ensure the safety and quality of the preparation. If the preparation can be autoclaved in a subsequent step, a 0.45μm filter element can also be used here to control the bioburden and intercept microorganisms and fine particles. The choice of filter is also based on the raw material and the characteristics of the preparation.

Final sterilization filtration

Tank Vent filtration

A gas breather port filter is usually added to the upper vent of the dilute and concentrated dosing tanks. This helps to prevent microbial contamination and impurities from entering the pharmaceutical process and ensures the quality and purity of the final drug product. Examples include water for injection WFI and breath port filtration for sterile product storage tanks.

What Sanitek can do in this procedure?

By ensuring the functionality and durability of your equipment, Sanitek’s tailored filtration solutions contribute to long-term cost savings on maintenance and operational expenses.

Sanitek’s market-leading filtration systems specialize in the removal of oil and particles from water streams, addressing environmental regulations or injection well standards. Our innovative offerings encompass oil adsorptive guard filters, high-efficiency coalescers, as well as disposable and washable solid cartridge solutions.

For this specific application, Sanitek designs and manufactures filter cartridges and filter housings. Our Oltek pleated filter cartridge and Oltek string wound filter cartridge stand out as ideal solutions for maintaining the required purity levels in this condition.

Need Help?

You can find the right application or product using our Tool, or through our Chat Bot.

Quick Contact

Please fill out the contact form below and a Sanitek representative will be in contact with you shortly.

    error: Content is protected !!