General
How many systems will each kit test?
Each v:kit is designed to qualify two systems (2 x HPLC or 2 x GC).
How many Initia kits do I need?
Initia kits contain software licensed for one PC. We suggest that you install this to an office PC or a laptop. The software does not communicate directly with your HPLC or GC so does not need to be installed on the PC that contains your CDS (chromatographic data system). If you are testing HPLC and GC in one location you will need one Initia GC and one Initia 64 (HPLC)
Which Operating Systems?
Windows 2000, NT and XP are all supported by v:kit.
I have v:kit version one - can I upgrade?
Yes - v:kit version one will be supported for another 12 months. During this period you will have the opportunity to upgrade at a large discount. Contact NLG or your local dealer for details. Get Quote
Can I use v:kit ver 1 data discs with ver 2?
No - v:kit v2 will only operate with v:kit v2 data discs. We will continue to supply ver 1.x data discs for up to one year from the launch date. Existing users of v:kit ver 1.x will be offered a special discounted price to upgrade to the new software.
Do I need training?
Training is strongly recommended. Working in a regulated environment means training records are an essential part of laboratory compliance. Training is provided either at your site or via webcast. You will be provided with an official v:kit training certificate following successful completion of the session (HPLC - one day, GC - one day)
Will my systems pass?
v:kit is designed to test a system in the condition it is found. A FAIL result for any test is a valuable piece of information as it may prevent you from using a faulty piece of equipment. A system, which has been tested following a preventative maintenance service by a competent service provider, is very unlikely to FAIL. If a FAIL is reported the problem can be attended to and the system re-checked.
Each data disc supplied with a kit contains a number of test licenses. For example 10 test licenses per HPLC pump are contained on each Refill64 data disc. This allows you to re-test a pump should your first test produce a FAIL. You can fix the pump then re-test. Or if your HPLC is a high pressure gradient system you may have 2 (binary) or 3 pumps (ternary) to check per system.
HPLC
What is the shelf life of the v:kit solutions
The solutions are guaranteed for a minimum of one year from date of shipment except for fluorescence linearity standards which have an expiry date of minimum 6-months. Occasionally we may need to ship materials with shorter expiry dates but we will always contact you first to check this is acceptable.
Will v:kit validate PDA?
Yes- v:kit 2 now contains the choice of scanned or manual mode checks making wavelength accuracy checking on DAD/PDA photo diode array detectors very simple and effective.
Which HPLC's?
v:kit has been used for virtually every commercially available HPLC system and module. It is easier to say what it will not test for than what it will test. Detectors fitted with micro or semi-micro flow cells and the TSP UV6000 DAD may not be able to perform the standard UV Linearity test. Contact us if you are uncertain if your module can be tested.
- Agilent 1100 all modules
- Hewlett Packard 1050 and 1090
- Shimadzu LC-6A, LC-10A and LC-10Avp and LC-2010
- Waters 2690/2695 Alliance, 510, 600
- Merck-Hitachi LaChrom, L6000 series
- Jasco
- Dionex
- Varian
- Thermo
What's the difference between ver 1 and ver 2?
With almost three years of use on v:kit ver 1.0 for HPLC an entirely new program has been written to replace it. The graphical interface remains similar to v:kit ver 1.x but we have added in lots of additional functionality to give a more comprehensive and flexible validation package. The package is designed to allow for much faster OQ testing by less repeated data entry and by re-designing some of the tests. The main benefits are as follows:
21 CFR 11 compliant login module the same as used in GC v:kit
Administrator can opt whether or not to use module at point of Installation
Serial numbers names and re-calibration dates of validation tools all retained in system memory
Serial numbers of individual modules and system Ids automatically stored for rapid recall
Database of manufacturer and model names pre-installed to which the user can add too.
Detector Linearity tests now include the option to set PASS/FAIL based on r2 value as well as % deviation
Wavelength Accuracy test can be performed at 1,2 or 3 wavelengths from a choice of 9 in the range from 210 – 650nm
Improved usability for wavelength accuracy test with separate sub routine for scanning (i.e. DAD, PDA) detectors
Improved usability for temperature tests including being able to choose 1,2 or 3 temperature zones at 1,2 or 3 temperatures, naming of temperature zones.
Temperature testing PASS/FAIL now based on absolute temperature deviation rather than % deviation making low temperatures easier to work and bringing v:kit in line with major OEMs routines.
Dedicated sub-routine pf temperature accuracy test specifically for autosampler temperature testing.
Gradient testing now include the option to set PASS/FAIL based on r2 value as well as % deviation
Quicker gradient testing by allowing user to use 20 or 25% intervals as well as the original 10% intervals used in v:kit ver 1.0
Quicker autosampler testing with user selectable number of repeat injections from 6-10
Autosampler linearity check now available
Why are v:kit solutions better than the detector internal check?
The v:kit method of introducing standard solutions into the detector flow cell ensures that the detector is tested as it is used. Some detectors have an internal holmium filter which is inserted into the light path to check wavelength accuracy. This “self-check” is not independent and does not test the detector as it would be used for analysis. Other internal checks may involve checking for spectral lines such as the 656nm D2 line. A UV detector can be in specification at 656nm but be several nanometers out at 220nm. v:kit allows you to independently check for wavelength accuracy at 10 wavelengths between 200-650nm.
Can I validate an evaporative light scattering detector?
Yes -the solutions provided in the refractive index refill kit (order code VKT-RRI) may be used to demonstrated the linearity of response of an ELSD. The controlled temperature zones within the detector may be validated using the temperature accuracy OQ protocol in combination with a suitable temperature probe and calibrated digital thermometer.
GC
Which detectors can be tested?
FID and TCD are currently available. ECD and NPD are simply not used frequently enough in Pharma environments to justify a specific test.
Can I validate my Headspace Sampler?
Yes - there are specially written SOP's for dealing with headspace via direct injection (such as HTA and CTC) and for dynamic headspace (i.e. Agilent). These are not included as standard and must be ordered separately.
I have a GCMS - can I use v:kit for OQ?
Yes and no - standard GC v:kit tests can be used for the temperatures and flows but as yet we have no protocol for the MS. An MS specific version of the product will be available in the future.
What is the GC v:kit test column?
A 0.28mm ID capillary is supplied with your Initia GC starter kit. The column is not manufactured from silica and is virtually indestructible. It is a very specific length to allow for use during flow rate tests as well as in the PQ of the GC and autosampler system. Replacements can be ordered Get Quote.
How are the solutions supplied?
The detector and autosampler test solutions are supplied in sealed amber glass ampoules. These ampoules should be opened immediately before testing and their contents added to a suitable autosampler vial for introduction to your system. They have a shelf life of minimum one-year from the date of delivery.
Tools
Can I use my own tools?
Yes - providing they have a current certificate of calibration.
How often should I re-calibrate?
Yearly re-calibration is recommended or following repair if some damage has occurred to the tool. Tools can be re-calibrated locally or can be sent to NLG.
What's the advantage of using v:tools?
V:tools are the same tools used by the NLG Analytical service and compliance department. They've been successfully used in the field for several years and have proven themselves to be robust, reliable and fit for use in the laboratory OQ environment.
Does the starter kit (Initia LC or GC) also contain a calibrated flowmeter and thermometer etc?
No. Validation tools must be purchased separately. You can visit the tools section of this website or use your own calibrated devices.
Ordering Information
How do I order v:kits?
There are v:kit distributors through out the US- please contact us to find your local agent. Kits can also be purchased directly from Tovatech LLC. You should send a purchase order stating clearly your company details for invoicing and for delivery, the items you require and the quantity. We can help you if you are uncertain how to place your order. Just e-mail info@tovatech.com or call
973-913-9734.