01 — PROCESS REVIEW
Liquid sterilizing filtration
Is matching pore size enough to select a filter?
Start with the fluid properties and intended filter-use conditions. Separate supplier evidence from checks needed for the actual process.
Questions for your process
- Have you checked material compatibility and adsorption at the process-liquid composition, temperature, and contact time?
- Have you distinguished supplier validation evidence from items to confirm for the actual product and process?
- Have you reviewed the test liquid, wetting state, test conditions, and aseptic boundary together?
Confirm test methods and acceptance criteria against supplier evidence, actual process evaluation and approved site procedures.
Discuss this process ↗02 — PROCESS REVIEW
Gas and vent sterilizing filtration
What changes when a vent filter becomes wet?
Define gas supply and vessel venting conditions. Consider condensation and flow changes as well as normal operation.
Questions for your process
- Does the filter and housing configuration meet maximum airflow and allowable differential-pressure requirements?
- Have you identified locations where condensate may collect or the vent may become wet?
- Have you defined sterilization history, service life, and a suitable integrity-test method?
Confirm test methods and acceptance criteria against supplier evidence, actual process evaluation and approved site procedures.
Discuss this process ↗03 — PROCESS REVIEW
Single-use systems
How much should you check when changing one bag?
Define how the bags, tubing and connectors will be used together. Distinguish component evidence from checks on the assembled configuration.
Questions for your process
- Have you recorded intended use, fluid-contact conditions, and connection configuration in the user requirements?
- Have you reviewed materials and extractables data, sterilization, and the scope of leak checks for the complete assembly?
- Have you defined supplier change notification, transport and storage, and on-site installation conditions?
Confirm test methods and acceptance criteria against supplier evidence, actual process evaluation and approved site procedures.
Discuss this process ↗04 — PROCESS REVIEW
TFF · UF/DF
How do you match membranes and operating conditions for concentration?
Set concentration and recovery objectives, then plan comparative trials with the actual feed. Review membrane selection alongside cleaning and storage.
Questions for your process
- Have you compared membrane material, MWCO, and flow-path geometry for the target concentration and recovery?
- Have you defined conditions for evaluating pressure, flow, throughput, and product quality?
- For reuse, is the validation scope for cleaning, storage, and number of uses ready?
Confirm test methods and acceptance criteria against supplier evidence, actual process evaluation and approved site procedures.
Discuss this process ↗05 — PROCESS REVIEW
Virus filtration
How does virus-filter selection connect to process validation?
Identify what must be removed and what product must be retained. Define feed conditions, operating ranges and the performance evidence needed.
Questions for your process
- Have you defined the purpose and position of virus filtration in the process?
- Have you reviewed how feed condition, pretreatment, and operating conditions affect throughput and recovery?
- Have you defined the worst-case conditions and test scope for performance validation?
Confirm test methods and acceptance criteria against supplier evidence, actual process evaluation and approved site procedures.
Discuss this process ↗06 — PROCESS REVIEW
Depth filtration and clarification
What evidence should you use to compare clarification filters?
Define the feed solids load and downstream requirements. Prepare a consistent evaluation plan for candidate filters.
Questions for your process
- Have you documented feed properties and the materials and structure of candidate filters?
- Have you defined feed load, target clarification level, and the burden on downstream filters?
- Do you have test evidence to compare throughput, differential pressure, and product recovery?
Confirm test methods and acceptance criteria against supplier evidence, actual process evaluation and approved site procedures.
Discuss this process ↗
