Agilent Technologies NanoDis Manual de usuario

Agilent NanoDis

Quick Start Guide

NanoDis Quick Start Guide

This guide covers the following modules: Agilent NanoDis System (G7937AA)

Additional Equipment Required (Not Supplied)

Agilent Technologies does not supply Cross Flow Filters. For further information and recommended suppliers,

contact the Dissolution team (dissolution.hotline@agilent.com).

Installation of Peristaltic Pump Tubing and Cassettes

To install the peristaltic pump tubing and cassettes, complete the following steps:

1Remove the cassettes by pressing the barbed part of the cassette and pushing it upwards.

2Using the peristaltic pump tubing, attach the tubing adapters and fasten them into the cassettes. Ensure that the

tubing clips are embedded correctly, see Figure 1 on page 1.

3Ensure that the pressure control lever is fully open. Re-insert the cassette into the Peristaltic Pump and secure

them by re-attaching the side support bar, see Figure 2 on page 1.

4Adjust the pressure control lever so that sufficient pressure is applied to the peristaltic pump tubing to allow free

flow of the media. A flow rate of 40 corresponds to an approx. flow rate of 6.0 mL/min

CAUTION

Damage of equipment by overpressure

A closed top horizontal filter connection during experimentation can cause potentially

damaging pressure build-up in the filter and the system.

Leave open the top horizontal connection of the filter during experimentation.

Figure 1 Peristaltic Pump Cassette Figure 2 Installing Cassettes

NanoDis Quick Start Guide

NanoDis System Tubing Guide

The following Figure 3 on page 2 shows the components of the NanoDis System and provides information about the

required tubings.

Figure 3 Diagrammatic representation of the NanoDis System

Method Troubleshooting Guide

Controlling Peristaltic Pump Speed

The speed of the Peristaltic Pump is regulated by the manual controls on the front of the pump. It is suggested to run

a method with blank media and adjust the pump to achieve the correct speed. Start slowly, and increase the speed to

avoid overfilling, overpressure, or leakage.

Determination of Maximum Sample Volume

The maximum sample volume (VSampleMax) can be calculated as follows:

VSampleMax = VFilter — (VPrimeLoss — VPrimeTubing)

The Prime Tubing Volume (VPrimeTubing) is approximately 3.5 – 4.0 mL (determine based on supplied tubing.)

The Prime Loss Volume (VPrimeLoss) required is 3.5 mL minimum. It is suggested to add 0.5 mL to your Prime Loss

Volume, to ensure that the line is filled through the needle.

T1 708-DS – 850-DS Sample Cannula (6-Position: 1005–1920, 8-Position: 1005–1921)

T2 M1/4–28 to M1/4–28 Tubing Kit (1005–1729)

T3 Cannula Tubing Kit (5005–0066)

T4 Luer to M1/4–28 Tubing (1005–1953)

T5 708-DS – 850-DS Return Cannula (6-Position: 1005–1920, 8-Position: 1005–1921)

Table 1 Flow settings

Flow Setting Approximate Flow Rate

40 6.0 mL/min

60 8.5 mL/min

80 11.5 mL/min

NOTE

If the line is not filled sufficiently, the sample volume will be inaccurate as air will be delivered as part

of the desired sample volume.

T1 T2

T3 T4

Agilent 708-DS

Dissolution Apparatus

Peristaltic

Pump

Hollow-Fiber

Filters

Agilent 850-DS

Dissolution Sampling Station

1 43

NanoDis Quick Start Guide

Example 1:

VPrimeLoss = 4.0 mL (programmed in system)

VFilter = 3.0 mL

VPrimeTubing = 3.5 mL

VSampleMax = 3.0 mL — (4.0 mL — 3.5 mL)

VSampleMax = 2.5 mL

Calculation of Filter Outer Volume

The outer volume of the filter (VFilterOut) can be calculated as follows:

VFilterOut = VFilterTotal — VFilterMembranes

The total volume of the filter (VFilterTotal) is:

VFilterTotal = × r1² × lFilterEffective

r1= internal radius of the filter

lFilterEffective = effective length of the filter

The volume of the filter membranes (VFilterMembranes) is:

VFilterMembranes = (× r2² × lFilterEffective) × nFilterMembranes

r2= radius of the filter membrane

lFilterEffective = effective length of the filter

nFilterMembranes = total number of membranes in the filter

Insufficient Sample

The following actions are suggested if there is insufficient amount of sample:

Filter Overfill or Insufficient Filling During Sampling

The following actions are suggested if the filter is overfilled or there is insufficient filling during sampling:

Table 2 Suggested actions in case of insufficient amount of sample

Observed Problem Suggested Actions

Insufficient sample

amount

Preconditioning

•Increase the Peristaltic Pump time in the Method Parameter tab.

Prime Cycle

•Reduce Prime Volume to transport more material from the filter into the needle.

Alternatively, set the Prime Loss Volume to 0 for the same effect.

Table 3 Suggested actions in case of filter overfill or insufficient filling during sampling

Observed Problem Suggested Actions

Insufficient filling Set Syringe Overlap to 0 and increase the Peristaltic Pump speed.

Filter overfill Increase Syringe Overlap time to maintain filter volume within a controllable range. Review the

Peristaltic Pump speed.

www.agilent.com

Agilent Technologies Inc. 2022

Printed in Germany, Edition: 06/2022

*G7937-90000*

Part No: G7937-90000 Rev. A

Document No: D0016565 Rev. A

NanoDis Quick Start Guide

Strong Surfactant Media (e.g. > 5% SDS)

The following actions are suggested when using media with a high surfactant concentration (e.g. > 5% sodium

dodecyl sulfate).

Filter Care

Filter Conditioning

Condition the filters before using or storing them. For information about recommended volumes and media for filter

conditioning, refer to the documentation of the filter manufacturer (e.g. filter care guides).

Filter Cleaning

Create a cleaning method and use it after the analysis (post analysis). Use extended purge volumes and outer rinse

cycles, ensuring that sufficient volume is sampled through the needles. Replace the vessel media and rinse media for

this method.

Technical Support and Further Information

For technical support, contact dissolution.h[email protected].

Visit the Agilent Technologies website for useful information, support, and current developments about the products

and technology:

https://www.agilent.com/en/product/dissolution-testing/dissolution-apparatus/nanodis-system

Table 4 Suggested actions in case of media with high surfactant concentration

Observed Problem Suggested Actions

Foaming within lines or

filters

Reduce Peristaltic Pump speed, using the manual controls of the Peristaltic Pump.

Increase pump times proportionally, using the Method Development tab in the Dissolution

Workstation.

Foaming in syringes Reduce plunger speed, using the System Configuration tab in the Dissolution Workstation.

Increase aspiration dwell time in the 850-DS Autosampler, using the System Configuration tab

in the Dissolution Workstation.

It is possible to reduce the % surfactant required while increasing the Method rpm to overcome

foaming issues.

NOTE

Increased noise

The 850-DS Autosampler may generate increased noise when using lower plunger speeds. This is

normal behavior.

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