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.
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.