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CE IVD Labelling of Pastettes (Pasteur or Plastic Pipette)

Can Pastettes (Pasteur or Plastic Pipette) carry the CE IVD label?

hand-pastette-4Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD) provides the regulatory framework for manufacturers and for authorised representatives who wish to place in vitro diagnostic (IVD) products on the EU common market.  Products that satisfy the regulatory requirements are permitted to carry the CE IVD mark.

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination.

For a number of years, there has been confusion on whether products such as pipettes  could carry the CE IVD mark.

In 2012 the European Commission Directorate General for Health and Consumers issued guidelines on certain products to clarify the position on CE IVD marking.

http://ec.europa.eu/growth/sectors/medical-devices/documents/guidelines/files/meddev/2_14_1_rev2_ol_en.pdf

Further guidelines were issued in 2014.

http://ec.europa.eu/growth/sectors/medical-devices/documents/borderline/files/borderline_manual_ol_en.pdf

In both these sets of guidelines it is very clear that pipettes, are not permitted to carry the CE IVD mark as they are for general laboratory use only and are not specifically intended to be used for in vitro diagnostic examination.

Hence all such pipettes under the Alpha Laboratories brand of Pastettes will not be CE IVD marked once current stocks are depleted.

The products will still be available and manufactured to the same high standards – they will just not carry the CE IVD mark.

If you require further clarification please contact us.

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Pasteur/Plastic Pipette Brochure

Take a look at the Pasteur/Plastic Pipette brochure. It’s full of useful information about the complete range of transfer and pasteur pipettes on offer, plus case studies and more.

It shows the full range of Pastettes (plastic or pasteur pipettes).  They are available in over 50 designs and can be used for many specialist as well as general purpose requirements. They provide a safe and convenient alternative to glass pipettes, available in numerous shapes and sizes.

Pastettes (plastic or pasteur pipettes) are available in sterile, as well as simply packaged non-sterile pack formats. Sterile inner packs of 20, 10 or single wrap Pastettes combine the security of aseptic transfers with the economy of use that suits your needs.

Pastettes are also available for custom requirements. Call Alpha Laboratories to discuss your specific design and packaging solutions.

Click this link to download your copy: Pasteur Pipette (Pastette) Brochure 2015 v1.1

Alternatively, explore the full range on-line on the Alpha Laboratories main website – Pastettes.

 

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Bristol Genetics Laboratory (Graduated & Fine Tip Pastettes)

The use of Pastettes at Bristol Genetics Laboratory

The use of Pastettes at Bristol Genetics Laboratory.

Bristol Genetics Laboratory (BGL) provides a comprehensive genetics service comprising of both molecular and cytogenetic analysis to primarily the South West but also to the rest of the UK and internationally. (more…)

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Graduated Pastettes Provide Accuracy and Convenience For Robertet UK Ltd

Graduated Pastettes Provide Accuracy and Convenience For Robertet UK Ltd

“The 1ml Graduated Pastette (Pasteur or plastic pipette) provides the precision needed”.  “We use a lot of Pastettes on a daily basis”  “Graduated Pastettes provide accuracy and convenience.”

The Robertet Group is a specialist company whose principal activities are the production and distribution of raw materials, flavours and fragrances.

Tony Jukes, Manufacturing Operations Manager, told us:

“In the applications laboratory here, we formulate trial batches of fragrances that are under development, for customers to test in their required applications. We work to very precise formulations, occasionally using up to 70 different raw materials for each trial batch. These components are often very expensive with some raw materials costing up to £20,000 per Kg. We cannot afford to waste any, so the accuracy of dispensing is essential. We have found that the 1ml graduated Pastette provides the precision that we need for this task.

(more…)

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Bristol Royal Infirmary (Extended Fine Tip Mini Pastettes)

Pastettes_in_Clinical_BiochemistryExtended Fine Tip Mini Pastettes used by Bristol Royal Infirmary.

The Department of Clinical Biochemistry at Bristol Royal Infirmary is a busy clinical laboratory processing around 1800 samples each day.

Samples arrive both directly from the hospital and from local GP surgeries. The  laboratory offers a full range of blood tests and most of these are processed through automated systems.

Some are still handled manually because they are either too complex to automate, or there is insufficient sample throughput to make it cost effective to automate.

Around 40 paediatric samples are received daily from the hospitals wards and outpatient services.

(more…)

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Dedicated Pasteur/Plastic Pipettes Website

Louis Pasteur - Inventor- of the Pasteur PipetteWhatever your application, from standard liquid transfer procedures to unique or unusual uses, this new website will help you find exactly the pipette you require.

An exclusive resource www.pasteur-pipette.com provides everything you need to know about Pasteur pipettes. Discover the history generating from Louis Pasteur’s invention, to the evolution of Alpha Laboratories’ extensive range of plastic Pastettes developed in response to customer needs.

Covering a wide range of uses within Life Sciences, Industrial and Clinical environments you can explore more than 50 models to find the right pipette for your requirements. Plus, you can read of other users real life stories of routine or novel applications.

Pastette has become a globally recognised name for quality manufactured Pasteur pipettes delivering the highest performance. You can choose from Graduated, Non-Graduated, Fine Tip or Micro Pastettes. For specific applications there are also the Dual-Bulb, Paddle or Aspirator Pastettes, each bringing unique features for additional functionality, convenience or safety.

If you still can’t find the perfect pipette for your particular use, Alpha Laboratories also offers a Custom Pastette Design Service that can create a bespoke model, length, volume, colour or packaging format. Alpha Laboratories has over 20 years experience creating made to order pipette designs to exact customer specifications giving you confidence when you request a quotation for your own specific requirements.

 

 

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Plymouth Algal Collection (Fine Tip, Graduated & Jumbo Pastettes)

Using a Pastette to drop algal culture onto a microscope slide

“Under a microscope a drop of the algae sample is added to a drop of culture media using an extended fine tip mini pastette.”

The Algal Culture Collection in Plymouth was founded over 100 years ago and the very first culture started at the centre is still alive and well today.

Around 500 different strains of algae of the 40,000 species known worldwide are maintained in the Plymouth laboratory. Forty of these were isolated at this laboratory.

Samples arrive at the laboratory from any algae of interest including harmful algal blooms. Under a microscope a drop of the algae sample is added to a drop of culture media using an extended fine tip mini pastette.

The samples are grown up and the process repeated until a pure culture is achieved.The collection originally grew cultures to supply fish farms to feed larvae and shellfish.Today algae is widely recognised as an important organism in our ecosystem.

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Wildlife Aid Centre (Fine Tip Pastettes)

This baby blue tit is finding that Alpha Pastettes make a good substitute for mum.

The use of Pastettes at The Wildlife Aid Centre.

Into The Mouths of Babes – Pastettes help British Wildlife get the best start in life.

This baby blue tit is finding that Alpha Pastettes make a good substitute for mum.

The Wildlife Aid Centre is often busy rescuing orphaned baby birds. They have discovered that the Small Volume Fine Tip Pastettes are ideal for providing water.

With small baby birds the windpipe is close to the front of the mouth. It is essential to avoid this when putting water into the mouths or they could drown.

(more…)

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