Ultrafiltration/Diafiltration (UF/DF) Operation SOP
Ultrafiltration/Diafiltration (UF/DF) Operation SOP template for running concentration, buffer exchange, membrane integrity checks, and transmembrane pressure monitoring with clear hold points and escalation triggers.
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Built for: Biopharma Manufacturing · Biotech Process Development · Pharmaceutical Quality Operations · Contract Manufacturing
Overview
This Ultrafiltration/Diafiltration (UF/DF) Operation SOP template defines the controlled sequence for preparing, running, monitoring, and closing a tangential flow filtration operation. It is built for batch or campaign work where the operator must confirm the work order, verify the membrane assembly, establish the work area, prime with approved buffer, perform a pre-run integrity test, transfer product, set operating parameters, and monitor transmembrane pressure, flow, and process stability.
Use this template when UF/DF is a planned production or development step and you need a repeatable record of concentration and buffer exchange. It is especially useful when membrane performance, product recovery, or pressure limits must be tracked against a defined tolerance. The structure also supports hold points for verification, escalation, and non-conformance handling, which makes it easier to manage deviations without losing control of the run.
Do not use this SOP as a substitute for equipment qualification, cleaning validation, or product-specific process development. If the run is exploratory, highly experimental, or lacks approved acceptance criteria, the procedure should be paired with a protocol or deviation record instead of treated as routine execution. It is also not the right template for unrelated filtration steps such as sterile filtration, depth filtration, or cartridge changeout unless the workflow is rewritten for those operations.
Standards & compliance context
- The template supports ISO 9001-style documented information by capturing approved parameters, execution evidence, verification, and deviation records.
- It aligns with GMP and quality-system expectations for controlled batch execution, traceability, and disposition of non-conforming process results.
- For hazardous or pressurized operations, the step structure can be adapted to OSHA process safety practices, including permit-to-work and escalation controls.
- If the run is part of a validated bioprocess, the SOP should reference the approved process window and any site qualification or change-control requirements.
- Where hazard symbols or warnings are used, the template can be adapted to ANSI Z535.6-style wording and visual communication practices.
General regulatory context for orientation only — verify current requirements with counsel or the relevant agency before relying on this template for compliance.
What's inside this template
Steps
This section matters because it turns the UF/DF run into a controlled sequence with clear actors, verification points, and stop conditions.
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Verify the work order and process parameters
The operator verifies that the batch record, target concentration factor, diafiltration volume, membrane specification, and acceptance criteria match the approved process instructions. The operator records any discrepancy and stops the procedure if the work order is incomplete or unclear.
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Inspect the UF/DF system and membrane assembly
The operator inspects the UF/DF skid, tubing, seals, clamps, and membrane assembly for visible damage, leaks, or contamination. The operator confirms that the membrane orientation and flow path match the approved setup.
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Don the required PPE and establish the work area
The operator dons the required PPE, clears unnecessary items from the work area, and positions clean collection vessels and labeled containers within reach.
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Prime the system with the approved buffer
The operator primes the system with the approved buffer until all lines and the membrane are fully wetted. The operator confirms that no visible air remains in the flow path and that the system pressure is stable.
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Perform the pre-run membrane integrity test
The operator performs the approved membrane integrity test before introducing product. The operator records the result, compares it to the acceptance criteria, and escalates any failure as a non-conformance.
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Transfer product into the UF/DF system
The operator transfers the product into the feed vessel or recirculation loop according to the approved sequence. The operator confirms that the transfer line remains secure and that the product is flowing as expected.
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Set the operating parameters
The operator enters or confirms the approved operating parameters, including flow rate, transmembrane pressure target, temperature limits, and any agitation or recirculation settings. The operator verifies that the values match the process specification before continuing.
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Monitor transmembrane pressure and process stability
The operator monitors transmembrane pressure, permeate flow, retentate volume, conductivity, and pH at the defined interval. The operator documents each reading and compares it to the approved tolerance range.
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Decision: determine whether a deviation has occurred
The operator compares the current readings and visual observations against the approved tolerance limits. The operator selects the appropriate branch based on whether the process remains in control.
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Continue concentration and diafiltration
The operator continues the concentration and diafiltration sequence by adding buffer and removing permeate according to the approved process. The operator confirms that the target volume reduction and buffer exchange progress are consistent with the work order.
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Escalate and contain the deviation
The operator stops or holds the process as required, isolates the affected equipment if necessary, and documents the deviation. The operator notifies the supervisor or competent person and waits for disposition before resuming.
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Complete the final membrane integrity test and record results
The operator performs the final integrity test after processing is complete and records the result in the batch record. The operator escalates any failure according to the non-conformance procedure.
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Document the run and release the equipment
The operator records all process parameters, deviations, integrity test results, and final product or intermediate disposition. The operator labels the equipment status and transfers the system to the approved cleaning or shutdown procedure.
How to use this template
- 1. The process owner reviews the work order, confirms the approved product, buffer, membrane, and operating limits, and assigns the operator and verifier roles.
- 2. The operator inspects the UF/DF system, membrane assembly, tubing, sensors, and connections, and records any damage, leaks, or missing components before setup continues.
- 3. The operator dons the required PPE, establishes the controlled work area, and confirms that permits, line clearance, and material status are complete.
- 4. The operator primes the system with the approved buffer, performs the pre-run membrane integrity test, and escalates any failed result before product transfer.
- 5. The operator transfers product, sets the operating parameters, monitors transmembrane pressure and process stability, and documents deviations, sampling, and end-of-run disposition.
Best practices
- Verify membrane type, surface area, and lot status against the work order before any fluid enters the system.
- Record the initial and running transmembrane pressure values at the same interval throughout the run so drift is visible.
- Treat a failed integrity test as a stop condition and route it to deviation handling before product transfer.
- Use the approved buffer for priming and diafiltration exactly as specified, including pH, conductivity, and temperature limits.
- Assign one role to monitor the trend data and another to perform physical adjustments when the process is sensitive to pressure swings.
- Photograph or otherwise capture visible leaks, wet spots, or membrane damage at the time they are found, not after shutdown.
- Document every buffer change, sample pull, and parameter change in real time so the batch record stays audit-ready.
What this template typically catches
Issues teams running this template most often surface in practice:
Common use cases
Frequently asked questions
What does this UF/DF Operation SOP template cover?
It covers the day-of-run sequence for ultrafiltration and diafiltration, from work order verification and equipment inspection through priming, integrity testing, product transfer, parameter setup, monitoring, and shutdown. The template is written for tangential flow filtration operations where concentration and buffer exchange are controlled against defined tolerances. It also includes verification points, escalation criteria, and documentation prompts so the run record is usable as documented information.
When should I use this SOP instead of an ad-hoc run sheet?
Use it whenever UF/DF is a repeatable production or development step that needs consistent operator execution and traceable records. It is especially useful when the same skid, membrane cassette, or single-use flow path is used across batches and you need a standard sequence for setup, monitoring, and release. If the activity is a one-off troubleshooting exercise with no defined acceptance criteria, a separate deviation or investigation form is usually better.
Who should run this procedure?
A trained operator or technician should execute the routine steps, with a competent person or supervisor reviewing critical hold points such as membrane integrity, parameter limits, and product disposition. If the process involves hazardous materials, sterile product, or pressure-related risk, the role assignment should reflect site training and permit-to-work requirements. The SOP should make clear which steps require independent verification and which can be performed by the same role.
How often is UF/DF operation performed?
The frequency depends on the process, but the SOP is designed for each production batch, campaign run, or development trial where concentration or buffer exchange is required. It can also be adapted for recurring cleaning or pre-use checks if your site separates those activities into adjacent procedures. The key is that the template supports a repeatable cadence with batch-specific parameters captured each time.
Does this template help with GMP, ISO 9001, or similar requirements?
Yes, it supports documented information practices by capturing what was done, by whom, when, and against which approved parameters. It also helps align with GMP-style expectations for controlled execution, verification, deviation handling, and traceable release decisions. You should still adapt the template to your site quality system, validation package, and any product-specific acceptance criteria.
What are the most common mistakes this SOP helps prevent?
Common failures include skipping the integrity test, using the wrong buffer for priming or diafiltration, ignoring rising transmembrane pressure, and failing to document deviations in real time. The template also helps prevent unclear role ownership, which often leads to missed verification or delayed escalation. Another frequent issue is continuing a run after membrane fouling or leak indicators appear without a defined stop-and-review step.
Can I customize this SOP for different membranes, skids, or products?
Yes, and you should. The template is meant to be adapted for membrane type, cassette area, target concentration factor, buffer composition, allowable TMP range, and product sensitivity. You can also add site-specific hold points, sampling requirements, cleaning steps, and release criteria without changing the core run logic.
What should this SOP integrate with?
It should connect cleanly to batch records, equipment logbooks, calibration status checks, deviation forms, and cleaning or sanitization procedures. If your site uses electronic systems, it can also link to MES, LIMS, or maintenance work orders for traceability. The most important integration is procedural: the UF/DF SOP should reference the upstream material release and downstream sampling or disposition steps.
How is this better than a free-form checklist?
A free-form checklist often tells the operator what to remember, but not what to verify, when to escalate, or how to document a deviation. This SOP template gives each step an actor, an action, an expected outcome, and a clear boundary for acceptable process behavior. That makes it easier to train new staff, review runs consistently, and defend the record during quality review.
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