v:kit for hplc and gc iq/oq/pq

may 2006

 

dear reader,

welcome to the v:kit newsletter. in this publication we aim to keep users and distributors updated on the latest developments in the equipment qualification arena.

in this issue

·  calculate cost per qualification

·  order evaluation v:kits now for a very affordable price

·  take advantage of a new deal on liquid flowmeters

·  compliance watch

·  v:kit success at analytica 2006



order evaluation v:kits now for a very affordable price

nlg have introduced a new evaluation version of hplc and gc v:kit

designed to offer users a low risk way of evaluating the full v:kit product the evaluation versions are complete v:kits containing everything that an initia kit contains - reference standards, SOPs, consumables and software. the evaluation kit has a 3-month expiry date as opposed to the one-year expiry of an initia kit.

ordering details:

part No: VKIT2-E64
description: hplc evaluation kit
price: £330.00

part no: VKIT-EGC
description: gc evaluation kit
price: £330.00

call Steve Luke on +44 (0)1625 574633 or e-mail info@v-kit.com for further details of these exciting new products.

order a low cost evaluation kit now



take advantage of a new deal on liquid flowmeters

the v:kit hplc liquid flowmeter is now available complete with v:kit auto_flow software for a new low price

ordering details:

part number: BNDL-VKIT-LFM3
description: v:kit hplc liquid flowmeter with 3-point calibration plus v:kit auto_flow software
price: £1200.00

the v:kit hplc liquid flowmeter with 3-point calibration alone is available for £1000.00

go to the v-kit website to see full flowmeter specifications and details of the auto_flow software

order now!



compliance watch

recent fda warning letter focuses on equipment qualification

these are extracts from a recent fda warning letter that focused on equipment qualification:

  • the written program designed to assure proper performance of automatic, mechanical, or electronic equipment is not adequate. [21 CFR § 211.68]
  • the quality control unit (qc) is not required to review the installation, operation, and performance qualifications of equipment upon completion
  • you do not fully understand the requirement for validation, which is to demonstrate that the process being proposed for use in manufacturing a drug product can meet predetermined goals or specifications
  • "fine tuning" of the protocol, if any, should occur before an attempt is made to validate a process
  • the validation protocol should be followed and any deviations or variations from the approved protocol should be investigated

click here to view a copy of the full warning letter



v:kit success at analytica 2006

the exhibition of v:kit at analytica 2006 was a resounding success!

as expected the product generated a lot of interest and the booth was visited by large numbers of decision makers keen to find out more about the unique features and benefits of v:kit.

if you want to exhibit v:kit in your geography contact nlg for details of how we can help

calculate cost per qualification

here is a simple calculation of cost per qualification that demonstrates what excellent value for money v:kit is

if we take the example of a laboratory with twenty hplc systems, each one with a gradient pump and uv detector, that is using v:kit for the first time.

the v:kits required to perform operational qualification on all these instruments are:

first year
part no.: VKIT2-I64
description: initiaLC hplc starter kit
end user price: £1200.00
quantity: 1

part no.: VKIT2-R64
description: gradient hplc refill kit
end user price: £330.00
quantity: 9

total cost for operational qualification on 20 hplc systems = £4,170.00.

cost per qualification = £208.50*

subsequent years
part no.: VKIT2-R64
description: gradient hplc refill kit
end user price: £330.00
quantity: 10

total cost for operational qualification on 20 hplc systems = £3,300.00.

cost per qualification = £165.00*

comparing the above to the typical cost of a single operational qualification from a major instrument vendor, £1,500.00, the excellent value for money that v:kit represents becomes clear.

* in addition to v:kit costs the laboratory must supply labour plus have available a calibrated liquid flowmeter and digital thermometer.

 

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