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VALIDATION SERVICES
Our comprehensive validation services are designed to meet the stringent requirements of the Pharmaceutical, Medical, and Food/Beverage industries. Supported by our in-house center lab—featuring dedicated microbiological and physical chemistry facilities—we ensure your liquid&gas filtration solutions are fully validated. We provide all necessary authoritative documentation to guarantee compliance and reliability for your most critical applications.
Confirm the correlation of integrity test values obtained underboth standard conditions and actual process liquid conditions,ensuring consistent, compliant filtration performance forpharmaceutical applications.
Integrity Test Confirm the correlation of integrity test values which were gotten using both standard and process liquid conditions.
Bacterial Challenge Test Include Survival test, Flushing test, Bacterial challenge test. According to ASTM F838 methodology, checking bacterial retention capability of membrane or filter at a minimum concentration of 107cfu/cm2 of filter surface area, under simulated process conditions.
Chemical Compatibility Different raw material or concentration composition of drug, different operating conditions and technological process, may change membranes or filters' structure. Ensure the compatibility of filter and process liquid. Ensure the reliability of filter in process condition. Provide supportive data for filter selection.
Extractable Identification the chemical components that migrate from membranes or filters into a drug product or process liquid in proper solvents in worst case. It indicates maximum possibility of chemical components migrating from membranes cartridges.
Adsorption Check the adsorption ability of filter media in liquid filtration process.
Muti-use-cycle validation Confirm retention capacity of cartridges in normal process or simulated conditions after multiple use process.
Filter Cleaning process Provide the filter cleaning method for the used filter.
In line with ASTM F838 methodology, we test the bacterial retention capability of membranes/filters. Under simulated process conditions, the test uses a minimum concentration of107 cfu/cm2 of filter surface area to verify reliable microbialcontrol.
BacterialChallenge Test According to ASTM F838 methodology, checking bacterial retention capability of membrane or filter at a minimum concentration of 107cfu/cm2 of filter surface area, under simulated process conditions.
Particle entrapment Carry out particle retention experiment. Determine the retention ratio for specific size.
Extractable Identification the chemical components that migrate from membranes or filters into a drug product or process liguid in proper solvents in worst case. It indicates maximum possibility of chemical components migrating from membranes cartridges.
Chemical Compatibility Determine the membrane or filter whether or not can be used for specific process liauid.
Integrity Test Recommend suitable integrity test method for medical filter.
Adhering to ASTM F838 standards, we assess the bacteria!retention performance of membranes/filters. Under simulatedreal-world processing conditions, the test employs a minimumconcentration of 107 cfu/cm2 of filter surface area to safeguardfood/beverage safety and quality.
Bacterial Challenge Test According to ASTM F838 methodology, checking bacterial retention capability of membrane or filter at a minimum concentration of 107cfu/cm2 of filter surface area, under simulated process conditions.
Extractable Identification the chemical components that migrate from membranes or filters into a drug product or process liquid inproper solvents in worst case. lt indicates maximum possibility of chemical components migrating from membranescartridges.
Integrity Test Recommend suitable integrity test method for filter in Food / Beverage filtration process.
Durable ability Evaluate the durable ability by the change of filter after chemical or hot water treatment.
Lifespan Evaluate the lifespan of filter by change of the flow and pressure parameters in the process of using.
Taste Evaluate Taste and evaluate the liquid after filtration process.
CLIENT TESTIMONIALS
Thank you for the professional filtration validation services! The tests, especially integrity and bacterial challenge, were highly reliable. Chemical compatibility and extractables data ensured product safety, while multi-use validation and cleaning protocols guaranteed long-term performance. Highly trusted and perfectly suited to pharmaceutical needs.
We highly recommend the validation services from LOONG Filtration! The bacterial challenge test (per ASTM F838) and particle entrapment studies provided reliable data for critical microbial and particulate control. Extractables and chemical compatibility assessments further ensured product safety and filter suitability. Trusted partner for medical-grade filtration.
Their validation suite addresses our top priorities: product safety through rigorous bacterial challenges, and quality via integrity & extractables data. This comprehensive approach safeguards our brand and earns our utmost trust.
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services and develop the optimal validation strategy for your specific needs.
