Review current criteria
Check the test method, limits, test fluid and temperature, and filter configuration.
Biopharma · APPLICATION GUIDE
Integrity & Qualification
Prepare reliable test conditions together with the information needed for change control.
Review selection pointsDiscuss this applicationFIELD APPLICATION & FLOW
See the application in its industrial setting.
Review product locations and fluid paths.
APPLICATION IN CONTEXT
- Test gas
- Automated tester
- Filter/assembly
- Test record
- Evidence/change review
Connections to review
- 01 → 02 Test gas → Automated tester
- 02 → 03 Automated tester → Filter/assembly
- 02 → 04 Automated tester → Test record
- 04 → 05 Test record → Evidence/change review
Investigate failures under approved procedures. Alternative products require evidence, performance and change-control review.
A conceptual illustration created to explain equipment and application locations. It is not an actual product photograph, installation photograph or piping/wiring design.
Connection principles and operating/test methods
Hydrophilic membranes · Diffusion-test concept
GasMeasurement / control
Scroll horizontally to see the complete flow.
Concept diagram explaining a diffusive-flow test. Actual piping, test pressure, stabilization, and limits must follow the validated procedures for the filter and tester.
These conceptual views explain flow direction. Actual piping, wiring and physical flow rates require a separate design.
01 — PROCESS
Where does each step fit?
Define the intended use and conditions to identify the required role of each item.
Analyze causes and data differences
Distinguish equipment leaks, wetting, and settings from differences in supplier documentation.
Quality assessment and change control
Reach a conclusion through established investigation and retest procedures and approved comparative testing.
02 — SELECTION
What should be selected and verified?
An integrity test failure does not necessarily mean the membrane is damaged. Investigate wetting, test fluid, temperature, system leaks, and test settings. Compare alternatives based on materials, validation, and process performance as well as dimensions.
Scroll horizontally to review all columns.
| Process objective | Step to review | Selection evidence |
|---|---|---|
| Hydrophilic membranes for liquids | Bubble point / diffusion | Complete wetting, test fluid surface tension, area, and limits |
| Hydrophobic membranes | Suitable methods such as WIT | Manufacturer-validated method, temperature, stabilization, and configuration |
| Test failures | Root-cause investigation | Leaks, valve positions, residual liquid, settings, and history |
| Alternative filters | Documentation and performance comparison | Retention, integrity, E&L, compatibility, yield, and notification of supply changes |
Compare actual operating conditions with supplier evidence and confirm the required performance and validation scope.
03 — OPERATING CHECKS
Use operating data to identify improvements.
Do not repeat testing until a pass is obtained
Follow approved failure investigation and retest procedures, retaining the initial result and the history of actions taken.
Do not directly apply water-based criteria to product fluid
Surface tension and wetting characteristics may differ. Confirm the correlation for testing with product fluid.
Create a documentation list for each item
Compare test certificates, materials, traceability, sterilization, retention performance, and the supplier’s change control practices.
04 — QUESTIONS
Frequently asked questions
Does passing an integrity test guarantee batch sterility?
It is an important check of the condition of the filter concerned, but it does not replace the overall aseptic process or batch quality assessment.
Can a replacement be made immediately if the material and pore size match the current product?
Process performance and validation data may differ. Comparison against predefined acceptance criteria and change control are required.
05 — APPLICATION REVIEW
Prepare the conditions for a technical discussion.
These details help narrow the configuration and the evidence to review.
- Filter model, quantity, and area
- Test method, limits, and test fluid
- Temperature, wetting, and sterilization conditions
- Failure logs and action history
- Required documentation and acceptance criteria for alternatives
MANUFACTURER PRODUCTS
Explore product applications and their official sources.
Confirm model suitability and supply scope through a technical review. Use each card to make an enquiry or review official manufacturer information.
ROKI TECHNO
PES membrane cartridge filter
A hydrophilic PES 0.2 μm membrane cartridge described for sterilizing filtration of pharmaceutical liquids. Verify compatibility, microbial retention and integrity-test conditions for the actual process.
Enquire about this productManufacturer company information ↗
Conceptual schematic · not an actual product photoAn original schematic of the pressure-hold test principle. It does not show the manufacturer’s actual equipment, supplied configuration or test procedure. Confirm food-and-beverage filter/test conditions; pharmaceutical suitability and qualification require separate validation evidence.
ROKI TECHNO
Pressure-hold integrity testing equipment
The manufacturer presents this configuration for pressure-hold testing of sterilizing membrane filters in food and beverage production. Confirm the filter and test conditions against item-specific documentation.
Enquire about this productManufacturer company information ↗Product photographs and manufacturer images use permitted official materials and source links. Original explanatory schematics are identified separately from actual product photographs.
Review what changes when replacing a product.
Compare connection, operating and documentation requirements against the current product code and reason for replacement. Separate verified matches from items needing more evidence or evaluation. Nominal volume or pore size alone does not establish equivalence.
- Current manufacturer and product code
- Reason for change: timing, cost, operating issues or other needs
- Equipment, housing, support vessel, connections, operating and sterilization conditions to retain
- Documentation and customer evaluation needed for the change
Review your filtration requirements
Selection, replacement or quantity and lead-time review. Start with the information you have.