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Q. What does any analytical laboratory need?
A. Accurately produced, GMP compliant mobile phase that underpins the integrity of analysis and your products.
How to achieve it? The Prep 5000 solution preparation system from kromega will be the first instrument that meets that requirement.
Accomodates 10 solvents for mobile phase production in a closed-loop system with accuracies of 0.05%.
Unique Benefits
- Huge cost savings
- Gravimetric closed loop system ensures high accuracy
- Repeatability – automated, no human error
- Buffer option using recirculation for pH adjustment
- Up to 10 solvents at any time
- Touch screen system for easy method creations and re-selection
- Label printing functionality
Huge Cost Savings
- Reduced labour costs for mobile phase production
- Less skilled staff
- GLP compliant, error free mixes every time
- No volumetric flask or related cleaning costs
- No costs for pre-mix solvents
- Minimized waste as batch sizes variable
- Automated quick production
How does it work?
The clever design has been conceived so that any lab can quickly, easily and accurately produce their own mobile phase or a solvent mix.
To do this, you connect to the instrument over wifi/USB using the provided iPadMini, with user accounts at 3 levels:
Administrator: Administer accounts and all the functionality of a Superuser.
Superuser: Create new mobile phase recipes and all the functionality of a User.
User: Run pre-defined recipes, follow the on screen instructions and watch your solution be
created.
- As standard: 3 built in pumps allowing for 3 solvents to be mixed. Can accommodate up to 7 additional pumps and 2 pH buffer / auxilliary pumps to your requirements, allowing a maximum of 10 solvents, and 2 pumps for auxilliary functions, pH control / mixing.
- Fully configurable label printer, with full RNS codes included for full GMP compliance.
- Balance that weighs to an accuracy of 0.03mg.
What Problems Does It Solve?
Do you make your own solutions using a volumetric method?
You will encounter inaccuracies as a result of temperature and the effect it has on chemistry. As a manual process, this also prone to human error – spillages, breakages, inaccurate measring etc. The Prep 5000 uses a gravimetric closed-loop process, where changes in temperature have no effect on the weight of the solute.
Do you buy pre-mixed mobile phase?
You know that pre-mixed mobile phase has an extremely short shelf life, and is expensive. This process allows you to bulk buy solvents, and just mix small quantities as and when required, resulting in huge cost savings, as well as less admin overhead / ordering issues: wastage is almost totally eliminated.
Do you require adjusted pH buffer?
By specifying the recirculation option, the unit has the added feature of buffer mixing and pH measurement by using a special recirculating pump and flow through pH sensor.
I work to GMP standards – can the Prep 5000 meet this need?
This unit has all the traceability required to meet the needs of regulatory bodies. Calibration and full audit trails you are in safe hands. Can also download all historic method information via USB/Ethernet as required. In addition, there are user programmable fields to record LIMS or Lab Notebook Data.
Change in solvent density as temperature increases by 5° C |
|
|---|---|
| Solvent | % Decrease |
| Acetone: | 0.758 |
| Acetic Acid: | 0.510 |
| Methanol: | 0.827 |
| Ethanol: | 0.825 |
| n-Propanol: | 0.503 |
| Toluene: | 0.616 |
| Carbon Tetrachloride: | 0.401 |
| Chloroform: | 0.422 |
| Methylene Chloride: | 0.513 |
| Water: | 0.116 |
| Cyclohexane : | 0.706 |
| Dimethyl Sulfoxide: | 0.497 |
Gravimetric Dilution: More Accurate than Volumetric
Solutions prepared using volumetric glassware are inherently inaccurate because of the density change of the solvent as the laboratory changes temperature. The magnitude of this error can be understood by referring to Table 1. Since Borosilicate (Pyrex™) glassware changes volume by only 0.013% over the same temperature span, the errors caused by this volumetric change can easily be as high as 0.5%.
Modern analytical instruments can routinely measure to an accuracy much better than 0.5%; however, in order to reach this potential, the solutions used in these techniques must be prepared to an accuracy three to ten times better (0.16% to 0.05%).What are the costs of solvent mixing & solution preparation using the volumetric method vs the gravimetric method (Prep 5000)?
What are the costs of solvent mixing & solution preparation using the volumetric method vs the gravimetric method (Prep 5000)?
- The cost of purchasing, replacing and cleaning of volumetric glassware. With the Prep 5000, this is replaced by the cost of cheap solvent containers.
- The cost of wasted solvent. With the Prep 5000, 135 ml or 653 ml of a solution can be prepared as easily as one litre. Solvent waste is reduced to nothing.
- The safety cost of handling solvents. The Prep 5000 is a closed system. The exposure to spilled solvents, broken glassware and harmful solvent vapors is reduced.
- The cost of loosing laboratory integrity. This is the highest cost of all. What price can be put on mis-identifying a peak in a chromatogram because the solvent was not mixed accurately or a mislabeled solvent was used? The GMP Compliant Prep 5000 prepares mixtures to an extremely high accuracy — every time. A label is also printed to document the preparation. This minimizes the cost of re-works, non-conformance investigations and the costly delays that could result in not shipping finished product.
