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Are You Compliant When it Comes to Pipetting?

Are You Compliant When it Comes to Pipetting?
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Are You Compliant When it Comes to Pipetting? - 1

Application Note March 11, 2020 Keywords or phrases: GMP, Good Manufacturing Practice, GLP, Good Laboratory Practice, Quality system, compliance, pipetting Are You Compliant When it Comes to Pipetting? Guidelines to Ensure Compliance with Good Laboratory and Manufacturing Practices Paulus Artimo1*, Joni Åke1, Emilia Varhimo1 1. Sartorius Biohit Liquid Handling Oy, Laippate 1, 00880 Helsinki, Finland * Correspondence E-Mail: paulus.artimo@sartorius.com Introduction When developing or testing your medical device, there is always the question: are you following methods for current Good Laboratory Practice (cGLP) or current Good Manufacturing Practice (cGMP)? In this practical guide, we’ve compiled a list that you can follow to give you peace-of-mind on the topic of compliance. Quality systems and standards regulating product development and manufacturing of pharmaceuticals, medical devices, and the way clinical studies are conducted, such as GLP, GMP and ISO 9000 series, require that appropriate and technically valid standard operating procedures (SOPs) are followed and a regular, documented maintenance and calibration process is in place for all instruments. In this guide, we’ll look into some tools and principles that can help with these demanding requirements, especially when it comes to your pipetting practic

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Are You Compliant When it Comes to Pipetting? - 2

ENV/MC/Chem(98)17 Section II Good Laboratory Practuice Principles 4. Apparatus, Material, and Reagents 2. Apparatus used in a study should be periodically inspected, cleaned, maintained, and calibrated according to Standard Operating Procedures. Records of these activities should be maintained. Calibration should, where appropriate, be traceable to national or international standards of measurement ENV/MC/Chem(98)17 Section II Good Laboratory Practuice Principles 1. Test Facility Organisation and Personnel 1.1 Test Facility Management’s Responsibilities 1. At a minimum it should: (e) Ensure...

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Are You Sure About the Volume? – a Human Factor To be certain that your measurements are in accordance with the study plan and relevant SOPs, your pipette should have a simple and unambiguous volume display with clear digits (Fig. 4). This way, volume setting is effortless and a quick glance is all it takes to affirm that you are using the intended volume setting, thus keeping your mind on your experiment. If you choose a mechanical pipette, make sure that the volume display clearly shows all digits to ensure that volume setting and checking doesn’t take your mind off of your work. A...

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Are You Compliant When it Comes to Pipetting? - 4

Supplement 2 Calbration and Maintenance Program Most laboratory quality systems require a regular calibration and maintenance program for pipettes. Today, laboratories commonly use external service providers for this labor-intensive work that require highly sophisticated quality systems. 1. What Should Be Done? The pipettes should regularly be maintained according to the manufacturer’s instructions. The maintenance consists of cleaning and greasing of pipettes, as well as replacement of wearable parts. Alongside maintenance, the pipettes should have their performance verified by calibration...

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Sales and Service Contacts For further contacts, visit www.sartorius.com ©️ 2020 Sartorius Lab Instruments GmbH & Co. KG. Specifications and design are subject to change without notice. Status: 04 | 2020 Germany Sartorius Lab Instruments GmbH & Co. KG Otto-Brenner-Strasse 20 37079 Goettingen Phone +49 551 308 0 Finland Sartorius Biohit Liquid Handling Oy Laippatie 1 00880 Helsinki, Finland Phone +358 9 755 951 lhinfo.finland@sartorius.com USA Sartorius North America Inc. 565 Johnson Avenue Bohemia, NY 11716 Toll-Free +1 800 368 7178

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Are You Compliant When it Comes to Pipetting? 5Pages

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Are You Compliant When it Comes to Pipetting?
5Pages