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AN1004
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Page 1 of 6
CLEANING AND STORAGE OF TANGENX CASSETTES
1.0
PURPOSE
This purpose of this document describes the procedure for cleaning, and storage of
microfiltration (MF) and ultrafiltration (UF) tangential flow filtration (TFF) systems. This
procedure also describes the clean water flux performed on the MF and UF
membranes.
2.0
SCOPE
This document applies to personnel that operate the TFF system at TangenX.
3.0
RESPONSIBILITIES
Personnel: Performs and documents all activities outlined in this procedure.
4.0
PRECAUTIONS
Exercise caution when using cleaning solutions.
Wear appropriate personal protective equipment as required.
Clean all spills immediately and thoroughly.
Support all piping connected to the LOBE pumps on the TFF system to avoid damage
to the pumps.
Do not obstruct the ventilation holes underneath the system pumps or louvers on the
sides. If obstructed, the unit(s) may overheat. The operator should maintain
approximately 4 inches of clearance between all sides and any obstructions.
Do not spray pumps with liquids. The action may cause electrical shock.
The Material Safety Data Sheets (MSDS) pertaining to all cleaning solutions and
chemicals should be available and understood prior to use.
5.0
DEFINITIONS
MF: Micro-filtration
NWP: Normalized Water Permeability – the water flux rate at 20C. also referred to as
clean water flux.
TCF: Temperature Correction Factor – factor used to normalize temperature to 20C
TFF: Tangential Flow Filtration
TMP: Trans Membrane Pressure: The difference in pressure between the retentate
and the feed side of the membrane.
UF: Ultra-filtration
6.0
MATERIALS (AS LISTED OR EQUIVALENT)

TFF System

Soft Water

Purified Water, USP

Dedicated graduated cylinders
FOR REFERENCE USE ONLY
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CLEANING AND STORAGE OF TANGENX CASSETTES
7.0

Dedicated Glass Bottles

Dedicated Carboys

Waste containers with spigot

Calibrated Temperature Probes

Calibrated Timers

pH paper
REFERENCED DOCUMENTS
TX-0004-DV (1F), MF System Cleaning Form
TX-0004-DV (2F), UF System Cleaning Form
TX-0004-DV (3F), Clean Water Flux Log Sheet
8.0
PROCEDURE
8.1
General Instructions
8.2
8.1.1
Reference SOP’s for gowning requirements and personnel / material flow
procedures.
8.1.2
The steps outlined in this document are to be performed on the MF and UF
system consecutively.
8.1.3
Refer to TX-0004-DV (1F) for the MF cleaning steps and TX-0004-DV (2F) for
the UF cleaning steps.
Rinsing of the MF and UF Systems:
8.2.1
Open the feed vessel bleed valves and the permeate drain valve(s) on the
systems to drain the storage solution. Close the valves when the systems
are drained.
8.2.2
Fill dedicated carboys with USP Water per TX-00004-DV (1F) or (2F). Refill
the feed vessels and carboys as necessary.
8.2.3
Direct and verify all waste hoses are securely in the waste containers.
NOTE: Monitor the level of the waste container.
8.2.4
Close the feed vessel bleed valve and the permeate drain valve(s).
8.2.5
Verify the permeate valve(s) and retentate valve are open.
8.2.6
Pour USP Water into the feed vessel.
8.2.7
Start the feed pump by pressing the start key.
8.2.8
Ramp up the pump speed slowly, using the “UP” arrow.
8.2.9
Adjust the retentate valve and adjust the pump speed simultaneously until the
desired pressures are obtained.
FOR REFERENCE USE ONLY
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CLEANING AND STORAGE OF TANGENX CASSETTES
8.2.10
Rinse the retentate and permeate lines with USP Water until the pH is within
specification of 5-9.
NOTE: It is not necessary to measure the pH after the initial product
rinse, (Rinse 1).
8.2.11
Sample the retentate and permeate feed line(s) using pH paper to verify the
pH is within specification.
NOTE: Once the retentate line is within pH specification, recirculation of
the retentate line may be necessary to help rinse the permeate line(s) to
specification. If required, sample per batch record.
8.3
8.2.12
Stop the pump, and record the pH specifications on TX-0004-DV (1F) or (2F).
8.2.13
Drain any residual water from the feed vessel by opening the bleed valve and
the permeate drain valve(s). Close the valves when the vessel is empty.
Re-circulation of Cleaning Solutions Through the MF& UF Systems:
NOTE: The MF and UF systems may be held in 0.5M NaOH after the 30 or 45
minute recirculation. The maximum hold time for the systems to be held in
0.5M NaOH is ≤ 5 days.
8.3.1
Direct the retentate and the permeate line(s) to the feed vessel.
8.3.2
Close the bleed valve on the feed vessel and the permeate drain valve(s).
8.3.3
Open the permeate valve(s) and the retentate valve(s).
8.3.4
Heat and pour the cleaning solution into the feed vessel as specified in TX0004-DV (1F) or (2F).
8.3.5
Record the re-circulation start time on TX-0004-DV (1F) or (2F).
8.3.6
Start the feed pump by pressing the start key.
8.3.7
Ramp the pump speed slowly, using the “UP” arrow.
8.3.8
Adjust the retentate valve and adjust the pump speed simultaneously until the
desired pressures are obtained.
8.3.9
Re-circulate the cleaning solution through the system as specified in TX0004-DV (1F) or (2F).
8.3.10
Stop the pump, at the end of the re-circulation period.
8.3.11
Record the re-circulation end time on TX-0004-DV (1F) or (2F).
8.3.12
Open the feed vessel bleed valve and the permeate drain valve(s) to drain
the cleaning solution from the system.
8.3.13
Close the feed vessel bleed valve and the permeate drain valve(s) when the
system is drained.
8.3.14
Rinse the system as described in section 8.2 using USP Water as specified
TX-0004-DV (1F) or (2F).
FOR REFERENCE USE ONLY
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CLEANING AND STORAGE OF TANGENX CASSETTES
8.4
8.3.15
Repeat steps 8.3.1 – 8.3.11 following each different cleaning solutions per
TX-0004-DV (1F) or (2F).
8.3.16
Record each cleaning step on TX-0004-DV (1F) or (2F).
8.3.17
Cover the vessel after the final storage recirculation.
Clean Water Flux Procedure of the MF and UF Membranes
8.4.1
Verify the feed vessel bleed valve and the permeate drain valve(s) are
closed.
8.4.2
Add a sufficient amount of purified water to the feed vessel so that it does not
run dry while measuring the flow rate.
8.4.3
Insert a calibrated temperature probe in the feed vessel.
8.4.4
Direct the retentate line to the feed vessel.
8.4.5
Direct the permeate line(s) to the feed vessel.
8.4.6
Open the retentate valve and the permeate valve(s).
8.4.7
Start the feed pump by pressing the start key.
8.4.8
Ramp the pump speed slowly, using the “UP” arrow.
8.4.9
Adjust the retentate valve and adjust the pump speed simultaneously until the
desired pressures are obtained.
NOTE: Temperature, pressures, and cross flow rate must be kept
consistent in order to compare clean water flux values.
8.4.10
Measure the permeate flow rate into a graduated cylinder for one minute.
8.4.11
Calculate the TMP:
[ ( Feed Pressure + Retentate Pressure) / 2 ] – Permeate Pressure
NOTE: if there is more than one permeate line, use the average
permeate pressure.
8.4.12
Calculate and determine if the clean water flux (water permeability) is within
specification:
NWP = (Permeate flow rate / TMP) x (TCF from Attachment A) NWP ≥ 80%
of Initial NWP
NOTE: Temperature correction may be necessary to determine water
permeability. Refer to Attachment A for Temperature Correction Factors
(TCF).
8.4.13
Stop the pump and record water flux specifications on TX-0004-DV (3F)
NOTE: If the clean water flux does not meet specification, contact the
area supervisor or designee.
8.4.14
Open the feed vessel bleed valve to drain any residual USP Water from the
feed vessel. Close the valve when the vessel is empty.
FOR REFERENCE USE ONLY
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CLEANING AND STORAGE OF TANGENX CASSETTES
9.0
ATTACHMENTS
Attachment A1 to A3: Cleaning Log(s)
TX-1004-DV (1F), MF System Cleaning Form
TX-1004-DV (2F), UF System Cleaning Form
TX-1004-DV (3F), Clean Water Flux Log Sheet
FOR REFERENCE USE ONLY
Document No:
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AN1004
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Page 6 of 6
CLEANING AND STORAGE OF TANGENX CASSETTES
Attachment B: Temperature Correction Factors
Water Temp.
(C)
Temperature Correction Factor
(TCF)
15
1.139
16
1.109
17
1.081
18
1.053
19
1.027
20
1.000
21
0.978
22
0.955
23
0.933
24
0.911
25
0.890
26
0.871
27
0.851
28
0.833
29
0.815
30
0.798
31
0.781
32
0.765
33
0.749
34
0.734
35
0.719
FOR REFERENCE USE ONLY