When designing the filtration process, appropriate filters should be selected and process parameters determined based on the properties of the medium to be filtered and the purpose of the process.
The sterilization filtration process should select a 0.22 micron (smaller pore size or the same filtration efficiency) sterilization grade filter according to the process purpose. A 0.1 micron sterilization grade filter is commonly used for the removal of mycoplasma.
Microbial control is implemented throughout the entire process of sterile drug production to avoid microbial contamination. Before the final sterilization filtration, the microbial contamination level of the filter medium is generally less than or equal to 10cfu/100ml.
When selecting filter materials, full consideration should be given to their compatibility with the medium to be filtered. Filters must not have adverse effects on product quality due to reactions, release of substances, or adsorption with the product. The sterilization filter must not shed fibers, and it is strictly prohibited to use filters containing asbestos.
The reasonable filtration membrane area needs to be evaluated through scientific methods. Excessive area may lead to a decrease in product yield and an increase in filtration costs; A small filtration area may result in prolonged filtration time, mid process blockage, and even product scrap.
Attention should be paid to the rationality of the filtering system structure to avoid hygiene blind spots. The inlet and outlet of the filter have a certain flow limiting effect. Suitable import and export sizes should be selected according to the process requirements.
When selecting a filter, process parameters such as filtration temperature range, maximum filtration time, filtration flow rate, sterilization conditions, inlet and outlet pressure difference range or filtration flow rate range should be determined based on actual process requirements, and it should be confirmed whether these parameters are within an acceptable range.
When pharmaceutical manufacturers choose sterilization filter suppliers, they should review the verification documents and quality certificates provided by the suppliers to ensure that the selected filters are sterilization grade filters. Pharmaceutical manufacturers should manage sterilization filter manufacturers as suppliers, such as conducting document audits or on-site factory audits, signing quality agreements and product change control agreements, etc.