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Visit Miclev's stand (no. 02) at Cleanroom Expo DK 2023, Hotel Bella Sky Copenhagen, 8-9 November. We will exhibit some of our new products, e.g. self-saturation mop and wipe fill-pack and disposable products.

Cleanroom Expo Dk is one of Denmark's largest cleanroom conferences for the Life Science industry, with an exciting program for participants from primarily companies that work in cleanroom environments on a daily basis. Invitation and programme

The New GMP Annex 1: Impact on Media Used for Environmental Monitoring - How should we handle environmental isolates in Microbiological QC testing?

Register to this interesting 40 minutes free of charge webinar, where Brice Lantheaume from Microbiologics® will dig deeper into this subject and observations related to the use of environmental isolates in microbiological quality control testing.

Topics to be discussed:

• Why include environmental isolates in pharmaceutical testing?
• Factors which make an organism objectionable
• Determining which organism to use in routine Microbiology testing

Presenter: Brice Lantheaume, Technical Support Specialist Europe, Microbiologics®

When? Wednesday, November 22, 2 PM CET

Register for your complimentary place here

Culture-based clinical testing just isn’t the same without the confidence of quick, convenient QC. Media and KWIK-STIK™ are made for each other. Once you see the simplicity and reliability of KWIK-STIK™, you will never want to stock up on culture media without its BFF.

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Small cleanroom environments without space for a cleaning trolley and/or varying disinfectant requirements – these are common challenges for too many cleanroom operators. With the Fillpack concept, you have maximum flexibility in the choice of liquid and can easily clean your cleanroom without using a trolley or trigger spray.

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Take a few minutes and read about how to validate protective cleanroom garment.

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With this last newsletter before summer, we want to wish those of you who will have vacation a nice holiday, and a nice summer to all our readers!

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Every lab worker should be wearing gloves that are highly protective and designed specifically for Life Science applications.

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The revision of the EU GMP Annex 1 for the manufacturing of sterile products was published and will be effective on the 25th of August, 2023. It requires that manufacturers of sterile products will apply the principles of Quality Risk Management (QRM) to the design and control of facilities, equipment (such as cleanroom garments), systems and procedures used for the manufacture of all sterile products.

Since operators represent the highest contamination risk inside pharmaceutical cleanrooms, the cleanroom garment systems are a critical part of the contamination control strategy. The new EU GMP Annex 1 is asking for a proactive, wholistic, risk-based and data-driven process validation.

Join DuPont GMP Annex 1 Webinars, taking place on Monday, June 5 at 10am-11am CET or on Friday, June 9 at 10am-11am CET which will present a structured approach to validating cleanroom garments, as well as the scientific test methods that are available for this validation, to meet the expectations of the new GMP Annex 1.

Register for Webinar June 5: Click here
Register for Webinar June 9: Click here

Visit Miclev's stand at Cleanroom Symposium & Exhibition R3 Nordic, Marienlyst Strandhotel in Helsingør, Denmark, May 23-24. Come and have a look at our new, exciting products that can facilitate your work! And don't miss the lecture ”How will the new GMP Annex 1 affect cleaning and disinfection of cleanrooms", held by Tor Hjelmér from Miclev.

Full program

Introducing Miclev's new corporate identity, centered around the concept of cells. These building blocks perfectly symbolize our unwavering commitment to growing together with our customers and partners.

The roll out of our new logo and look will happen in phases, so don’t worry if you don’t see it everywhere right away. Over the next few months it will be introduced on our website and all our printed and digital communication.

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Miclev is proud to present a complete set of disposal bags from ORUM International, to be used in all microbiological laboratories.

Eight different types of bag are available (click on the product name to read more):

• A simple SUPER BAG and a SFB Side filter bag with filter for pipetting after blending the solid food sample. Both are sterilised by Gamma irradiation.
• Sterile WCB WIRE COLLECTING BAG with metal closure and a COLLECTING BAG with adesive tape closure.
• A BIOHAZARD BAG and a BIOHAZARD POCKET SUPER BAG for biohazard sample transfer.
• A sterile CLEANROOM BAG to be used to transfer the biological material like Petri dish, Contact plate, swab from the Cleanroom to the analytical laboratory.
• A STERILBAG bag for autoclaving the infected material.

All bags are made of strong plastic material and packaged in recyclable material.

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

Read more & Register here

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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