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

january 2006

 

Dear Reader,

Welcome to the first issue of the v:kit newsletter. In this publication we aim to keep users and distributors updated on the lavkit_january_2006 developments in the equipment qualification arena.

in this issue

·  automated flow rate capture

·  upgrade to v:kit2

·  special offer on v:kit2 upgrade

·  compliance watch

·  forward this newsletter



upgrade to v:kit2

take advantage of significant improvements in v:kit by upgrading to version 2 for hplc

the graphical interface remains virtually unchanged and a substantial amount of additional functionality has been added to provide a more comprehensive and flexible qualification package.

Key features of version 2 are:

  • compliance – 21 CFR Part 11 compliant functions designed into the validated software
  • traceability – Traceable standards and tools used for all tests
  • efficiency – Calibration and instrument details stored in software for easy re-use
  • flexibility – Scope and stringency of tests can be configured
  • procedures – Detailed SOPs available for all tests

find out more...



special offer on v:kit2 upgrade

to make it even easier to enjoy the benefits up upgrading to v:kit2 we are offering the upgrade product for half-price up to 31 March 2006

v:kit2 upgrade (VKIT2-UP):

normal price
£400.00

special offer price
£200.00

standard distributor discounts still apply to the special offer price

order the upgrade



compliance watch

extract from an FDA 483 citation for Pharmaceutical Manufacturing Research Services (PMRS), PA, USA:

the hplc calibration SOP was deficient because the it ...“does not require recalibration after a major component is replaced, such as, pump parts or lamps. We observed in the logbook for HPLC [undisclosed] that a UV lamp was changed. However, subsequent precision/linearity tests were not performed.”.

request details on the use of v:kit for post repair qualification



forward this newsletter

v:kit distributors - would you like your customers to receive this newsletter?
There are two ways of making this happen:

  1. forward this email to them using the Forward email link at the bottom of the page
  2. send your customers' email addresses to us and we'll add them to the distribution list

send email addresses

automated flow rate capture

flow rate readings from the v:kit liquid flowmeter can now be captured automatically using the auto_flow feature in v:kit2 for HPLC.

automatic flow rate capture is an exciting new development for v:kit with the following benefits:

  • traceability: unbroken link between the measured and captured values
  • quality: elimination of transcription errors
  • efficiency: time taken transcribing flow rate values put to better use

when installed the auto_flow starter kit allows an unlimited number of flow tests to be performed using a specified flow meter up until the expiry date of the kit - which is typically the re-calibration date of the flowmeter. when the flowmeter is re-calibrated an auto_flow refill kit can be purchased.

the auto_flow feature is available in the following ways:

  1. auto_flow starter kit as an option on new v:kit2 InitiaLC kits
  2. auto_flow starter kit as an upgrade to existing v:kit2 systems
  3. the v:kit liquid flowmeter bundle

the v:kit liquid flowmeter bundle is a new product that combines the v:kit liquid flowmeter with a flow-only version of the v:kit2 software plus the auto_flow feature

prices

v:kit2 InitiaLC kit
VKIT2-I64: £1200.00

auto_flow starter kit
VKIT2-IAF: £330.00

v:kit liquid flowmeter bundle
BNDL-VKIT-LFM: £1150.00

v:kit liquid flowmeter only
VKIT-LFM: £870.00

normal distributor discounts apply

learn more about auto_flow

 

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