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SherpaPharma invites you to the webinar "Implementing a Robust Viable Environmental Monitoring Program," featuring the special guest, Abby Roth. This event will highlight the essential components of a viable sampling program and discuss key elements that an organization should consider when developing its program.

Date: May 21st

Time: 11:00 EST | 17:00 CET

Read more & register here

Miclev, in cooperation with Ecolab, invites you to the full day seminar "Providing a framework for effective contamination control regimes in line with regulatory requirements".

Whether you are a new start up facility, have cleaning and disinfection challenges or you are switching your disinfectant supply, the programme will take you through key factors to consider for regulatory compliance and the stages of implementing a new cleaning and disinfection regime.

Read more & register

Welcome to SherpaPharma's upcoming webinar "Navigating Change: Unraveling Environmental Monitoring Trending in Aseptic Manufacturing"! In this event, they will elve into the latest trends and challenges in environmental monitoring, a crucial aspect of aseptic manufacturing.

Date: 19th March
Time: 11:00 EST | 17:00 CET

Read more and register HERE

We are happy to introduce the new Klerwipe Sporicidal Low Residue Peroxide WFI pouch wipes, made of 100% polyester - the high grade solution for cleaning and disinfection of small surfaces and equipment in cleanrooms.

- Sterile 100% knitted polyester wipes with very low particulate levels
- Impregnated with 6% hydrogen peroxide and WFI
- Rapid and consistent application with a sporicidal effect
- Perfect for transfer desinfection
- Unit size: 200 x 200 mm
- Unit of sales: 20 x 10 wipes
- Shelf life: 24 months
- Available from: June 2024

Please contact Miclev for validation samples, supporting documentation or if you have any questions.

Read more about Klerwipe Sporicidal Low Residue Peroxide WFI Polyester Pouch Wipes HERE

As of January 1st, we have a new employee at Miclev - very welcome to our team, Shaquille Showe!

Shaquille will be working in our warehouse with logistics and we are really excited to have him on board!

We at Miclev are happy to have a small part in making the world a better place by supporting Hand in Hand with our annual Christmas donation.

Hand in Hand's vision is a world free from poverty. Through Hand in Hand's unique help to selfhelp model poor and marginalised people, the majority of whom are women, are strengthened with the capacity to work their way out of poverty.

Read more about Hand in Hand

In this edition of our newsletter, we especially want to highlight the importance of high quality cleanroom garments, that safely protect both operators and products in your processes.

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We are delighted to announce that Hannu Karhu has joined Miclev's team. Hannu will work as product specialist and his main focus will be the Finnish market.

Welcome to Miclev, Hannu!

PurMop BLACK® is the most innovative mop system ever, that offers you ergonomics and performance at the highest level.

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We are delighted to announce that Jenny Enbrant has joined Miclev's team as an Accountant Manager.

Jenny is a Qualified Accountant and has previously worked as Finance Manager at Mellersta Skånes kraft ekonomisk förening.

Welcome to Miclev, Jenny!

Tema Renrum is the leading Nordic conference and exhibition in cleanroom technology. Tema Renrum 2023 takes place at Scandic Infra City Upplands Väsby, November 28-29. Visit Miclev's stand and have a look at our new, exciting products that will facilitate your work!

Read more: Invitation and programme

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.

Miclev´s Sales Manager Tor Hjelmer, will speak about "Detergents and disinfectants in cleanroom – How will the new GMP annex 1 affect cleaning and disinfection of cleanrooms"

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

Read more & register

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