Chromatography Forum

Does anyone have any experience with solvent recyclers.

Any good brands to recommend?

Any problems using them in a GMP environment?

Ever done an evaluation of the cost savings?

Any suggestions or comments would be very much of interest.

Thanks!!

SolventTrak is quite good..

Thanks! Any others?

Has anyone used them in a GMP environment.

We've never used solvent recyclers here, never knew how one would demonstrate trackability and control for cGMP.

Hello to everyone interested in this topic;

SolventTrak is one of the best mobile phase recyclers in the market today. It is the only capable to eliminate peaks (contamination) no matter if there is positive or negative baseline drift during the chromatographic run.

In terms of the use of the SolventTrak within GMP environment we have good news. We (Green Lab) are developing a software designed to have full control over the SolventTrak and meets the GMP and 21 CFR Part 11 “Electronic Records and Electronic Signature” requirements. We hope to complete the software at the end of year 2012.

We would like to have this opportunity to invite you to let us know your specific software requirements or concerns.
Visit our web page to obtain more information about the SolventTrak Mobile Recycler System.

http://www.greenlab.ws/green_lab_5_002.htm


Green Lab

It seems to be more cost effective to use UPLC and HPLC methods using 2.1 mm columns rather than risk dirty baselines and unknown peaks (OOS investigations) by using solvent recyclers in a GMP environment.

Hi LC_Labrat,

Reduce the diameter and particle size of the column, the use of UPLC system, and the use of the mobile phase recycler among others, are excellent strategies to save solvents and be more cost-effective during the HPLC analysis.

One of the advantages of using the SolventTrak after change your HPLC method (Reducing column diameter) is that you can save even more mobile phase during your chromatographic run.

SolventTrak advantages:

1. Cheaper alternatives
2. Quick and easy implementation
3. It can be used in any isocratic HPLC method
4. No change to the actual method
5. Decrease analysis cycle time since less preparation of mobile phase is required
6. It will save still more solvent
a. After isocratic HPLC method has been developed, considering column size (Good method), you can save still more solvent using the SolventTrak.

7. Less HPLC waste will be generated
8. Less disposition costs related to the HPLC waste

Regards;
Luis

[quote="greenlab"]
/quote]
I have observed two questionts concerning GXP-Compliance in this thread. Please be so kind and give us a more detailed answer.

Hello to everyone interested in this topic;

As other equipments within the regulated laboratory or GMP environment, mobile phase recycler system
should be validated according to the user requirements and should be used according to
an approved procedure before use. Generally the following qualification tests are
required for this type of instrument:
• Installation Qualification
• Operation Qualification
• Performance Qualification

Since each chromatographic method has different peak shape and size, the PQ
should be performed by each method.

Expiration date of the re-used mobile phase should be determined for each
method.

In a regulated laboratory the following procedure should be prepared:
Operational procedure
Maintenance procedure
Calibration procedure

No internal or external observation will be generated if mobile phase recycler system is
properly validated and used according to an approved procedure.

Regards;
Green Lab

Hello to everyone interested in this topic;

Additional to qualify the mobile phase recycler and use approved procedures within GMP environment you should provide evidence that the mobile phase recycler was eliminating peaks during the run. This is where the use of software is important. The SolventTrak software will be capable to provide that evidence and in compliance with the regulation related to the use of software within GMP environment. You should validate the software according your company quality procedure before use it in a GMP environment.

Another GLP practice when using mobile phase recycler is to determine the quality of the recycled mobile phase before run the samples (System Suitability Test). You can use the system suitability test results to demonstrate that the recycled mobile phase is suitable for your analysis.

I hope this information will help you.

Regards;
Green Lab

I am happy to introduce you a new software (Zeleni) capable to have full control over the SolventTrak mobile phase recycler and meet the GLP requirement in the laboratory. For more information visit our web page http://www.greenlab.ws.

Zeleni Mai n Features:
Full Control - Zeleni is able to load method to the SolventTrak unit and set the valve to the waste position.

Simultaneous Data Acquisition- Zeleni is capable to acquire data from up to 100 SolventTrak units simultaneously and record data instantly in a secure database.

Performance Report - Zeleni can generate a report that can be used to demonstrate the performance of the SolventTrak in each chromatographic run.

Configuration Options - Zeleni can be easily configurated to be operated by ethernet, wireless or computer COM port.

User Privileges - The users can be configured to have different privileges according to the laboratory task and responsibilities.

Electronic Record Compliance - Zeleni is designed to meet the electronic record standard requirements.
• Password expiration
• Password length
• Entry attempt limit
• Audit trail record
• Method History