Written by Rachel Kohn
With continuous press reports on product recalls ranging from automobiles to pharmaceuticals to baby cribs, quality management (QM) takes on every greater importance for company management, its personnel, customers and shareholders regardless of size, product or service. The cost of product recalls in terms of lost revenues, reputation and lawsuits – let alone loss of life or health – presents a strong case for strong quality management systems in any company.
QM systems can be broadly divided into quality practices and quality standards. Learn which of these apply to your organization. Compliance procedures should be carefully spelled out in your company’s operation manual. Record-keeping is crucial. These must be maintained in a safe location and accessible by qualified third parties.
Some Examples of QM Practices
Here are some examples of QM practices. Detailed information on these and others is available on the Internet.
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Written by Bob Sandor
Sometimes a seemingly innocuous procedure can bollix up desired results. That’s why the old saw “real people don’t need to read directions” can frequently result in less than desired outcomes.
So it is with mounting Tovatech’s FlowCal 5000 liquid flow meter, a factory-certified digital liquid flow meter for use with any model HPLC pump. The accuracy and repeatability features of this precision device are maintained by proper use and regular cleaning, but are also dependent on proper mounting.
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Written by Bob Sandor
Fast, accurate calibration of flow rates used in HPLC flow systems can be compromised if the flow meter is not maintained. While GLP (good laboratory practices) call for annual flow meter recalibration by the manufacturer, improper use of these precision instruments can soon render them inaccurate.
A serious error is introducing in immediate succession two immiscible liquids into the flow meter. Either allow the first liquid to completely evaporate or introduce a third solvent in which the other two are miscible.
Dirty sensing tubes in FlowCal 5000 HPLC flow meters may cause bubbles to become entrapped. This can create falsely high readings. If bubbles are observed, a quick fix is to turn the unit off, wait approximately 2 seconds to allow it to drain, then switch it on. Contaminated tubes will also result in an “Error 4” reading denoting either the flow meter is not draining or the sensing tube is contaminated.
Another good practice is flushing the flow meter with methanol if it is not to be used for a week or more. This prevents algae growth in the tube.
Written by Josh Ferry
Accurate HPLC flow rate records not only indicate GMP but are crucial when the FDA comes to call. Digital liquid flow meters such as the FlowCal 5000 support FDA compliance for IQ, QQ and PQ validations in calibrating HPLC pump flow rates. Connecting these meters to a PC with an RS-232 interface transfers flow meter readings into Excel via the Windows HyperTerminal program. It is a three-step process whereby data are collected and displayed using HyperTerminl.exe, copied on a clipboard and pasted into Excel for analysis.
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