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What you need to know to protect patients and your laboratory: Microbiologics, in cooperation with CAP Today and industry expert Dr. Sebastian Grömminger, will highlight the critical differences between RUO and IVD and the importance of choosing the right clinical diagnostic products.

Date: Tuesday, March 28, 2023

Time: 9:00 am - 10:00 am Central Daylight Time (17.00-18.00 CET)

Speaker: Dr. Sebastian Grömminger

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The management of disinfectant residues has been elevated through the requirement to remove them being included in the 2022 version of Annex 1. The presentation will outline the principles and share relevant residue management approaches which can be implemented in your facility.

Presenter: David Keen, Director, Pharmaceutical Microbiology & Consulting at Ecolab

When? Tue, Feb 7, 2023 5:00 PM - 6:00 PM CET

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The next webinar in Ecolab's Masterclass series, will discuss the increased focus that the updated Annex 1 puts on disinfectant format selection and how the challenges associated will impact the end-user’s disinfectant choice.

When? Tuesday, January 31, 5 pm. CET.

Register for your complimentary place here

Due to popular demand, Ecolab is repeating the Annex 1 Masterclass series! Join them for the first session where Ecolab’s Madison Hoal will review the Annex 1 text on disinfection, how to interpret the guidance, and the impact on the pharmaceutical end user.

Presenter: Madison Hoal, Global Technical Consultant
When? Tuesday, January 24, 5 pm. CET.

Register for your complimentary place here

Webinars Annex 1 by Ecolab - Coming Up:

Disinfectant Format Selection - Tuesday, January 31, 2023

Disinfectant Residue Management - Tuesday, February 7, 2023

Disinfectant Validation - Tuesday, February 14, 2023

Material Transfer - Tuesday, February 21, 2023

Merry Christmas & Happy New Year from Miclev!

Our annual Christmas donation supports Hand in Hand.

This months highlights from Miclev.

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We are happy to introduce the most innovative mop system ever! PurMop BLACK® is a revolutionary mop system which offers ergonomics and performance at the highest level. Made of high-tech carbon fiber material (CFRP). Its aim is to be the most lightweight and most user-friendly cleanroom mop system worldwide. Only 0,650 kg!

• THE NEW CLEAN: designed for all cleanroom classes and applications: floors, walls, ceilings, without changing systems (ISO 5 GMP A/B)
• THE NEW FAST: higher area coverage, quick deployment. More space covered with a lower fluid consumption and better cleanability of corners and cavities.
• THE NEW STRONG: extremely robust and durable, highly chemical resistance and autoclavable.
• THE NEW LIGHT: minimum weight (650 g), maximum user ergonomics.
• THE NEW SUPERIOR: the smartest and most user-friendly cleanroom mop system: One-handed length adjustment (145 - 212 cm) and mopp-discarting by the push of a button.
  
  

Read more about PurMop BLACK®

With the draft version of EU GMP Annex 1, the requirement to wear cleanroom socks prior to entry into Grade C and Grade B cleanrooms was introduced.

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Annex 1 is now final, and compliance is a regulatory pharmaceutical industry requirement. Do you feel you have enough insight into the latest changes to ensure you are compliant? Are you ready for potential inspections and audits? August 2023 is not that far away!

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Visit Miclev's stand (no. 14) at Tema Renrum 2022, Scandic Infra City Upplands Väsby, 29-30 November. Come and have a look at our new, exciting products that can facilitate your work! And don't miss the lecture "Cleaning and disinfection in cleanrooms - how will the new GMP Annex 1 affect this work", held by Tor Hjelmér from Miclev.

Tema Renrum is the leading Nordic conference and exhibition in cleanroom technology: Invitation and programme

Come and visit Miclev's stand (no. 15) at Cleanroom Expo DK 2022, Hotel Bella Sky Copenhagen, 12–13 October 2022. We will exhibit some of our new products, e.g. sterile disinfection and disposable products. You will also be able to join our competition and win nice prices!

Cleanroom Expo Dk is a two-day conference and exhibition for the Life Science Industry. Invitation and programme

Where High Contamination Control Standards are Crucial - Discover our latest portfolio addition from DuPont™, a clean-processed and sterile Tyvek® IsoClean® IC 193 B Coverall with attached hood and overboots, developed to serve the needs of pharmaceutical, biotechnology and medical device manufacturing settings, where high contamination control standards are crucial to ensure clean processes and the highest quality of products.

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The work done in cleanrooms is sensitive, highly specialized and requires a glove that offers protection, as well as a superb fit to maximize comfort for longer-wear times. There are many different factors to consider when selecting a disposable glove, including fit, thickness, barrier protection, texture, and grip (sometimes called “finish”). Ensuring that cleanroom operators have the correct glove is critical and can help lead to a better user experience.

White paper: Texture vs. Grip - Why it matters for your cleanroom gloves

Visit our stand and have a look at what's new on the market regarding sterile disinfection and disposable products for cleanrooms. And: Join our competition and win nice prices!

The 51st R3 Nordic Symposium takes place 29th – 31st of August 2022 at Naantali Spa in the sunshine town Naantali on the south-west coast of Finland.

The symposium programme will cover the use and applications of cleanroom technology and contamination control and there will be plenty of breaks in the program during which the participants can visit the exhibition area.

We hope to see you there!

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All 5 USP <60> Strains for Bcc Testing in 1 Kit - Simplify your Growth Promotion Testing with EZ-Accu Shot™.

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Don’t miss the final webinar in Ecolab´s CCS series! Please join the very special guest presenter Dr Tim Sandle PhD for a complimentary webinar on CCS – A Case Study for Cleaning and Disinfection.

When? On Friday 10th June 2022 at 10:30 am CEST

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Test-ready microbial controls made with your environmental isolates and objectionable organisms: Microbiologics® simplifies environmental isolate and objectionable organism challenge testing with custom ready-to-use controls made to your specifications.

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Read our latest newsletter!

The second in Ecolab's CCS series, please join Ecolab Global Technical Consultant Juliana Nassette for this complimentary webinar focusing on delivering your CCS for Cleaning, Disinfection and Decontamination. When? Tuesday 10th May 2022 at 10:00 - 11:00 AM CEST.

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PUREZERO* Cleanroom Gloves in accelerator-free nitrile are designed to protect workers as well as the products and processes.

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Please join Ecolab's Senior Strategic Technical Consultant Helen Gates, as she kicks off the CCS webinar series with a complimentary webinar on CCS: Introduction to Contamination Control Strategy for Cleaning, Disinfection and Decontamination.

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Miclev offers a comprehensive range of sterile multi-packed BD syringes.

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In mid-March, Tor Hjelmér and Marie-Louise Måtegen from Miclev held the tailor-made internal training "Microbiological environmental sampling in cleanrooms" at Xintela in Lund. The training was much appreciated - here are some of the participants' reviews:

"I thought the whole setup was good. The entire environmental sampling, from which plate to use to sampling points, incubation times, reading and trends."

"I like that they refer to Annex 1."

“The course was well-structured and easy to understand. We got answers to our questions and more. The right level for our business."

"Information-rich course. Good content at a basic level but also good for us with a little more experience."

Contact Miclev if you want us to tailor an education to your company's needs.

Protecting processes, products and operators with cleanroom clothing: Most vaccine manufacturing processes depend on quality control at every step. Failures can not only be costly and dangerous, they may also compromise compliance. Cleanroom garments are necessary to protect both processes and products from contamination, while also protecting operators from the hazardous substances involved in manufacturing.

Find out how Tyvek® and Tyvek® IsoClean® coveralls and accessories can be beneficial in ensuring clean vaccine manufacture:

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Working aseptically can be challenging and you may need products that are packed to withstand the VHP gassing used for decontamination in the isolator. Most certain you also need to control the environment by airsampling and/or particle counting and use products that are special designed for these processes.

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