Shibaura Machine Company introduces medical moulding press for cleanroom environments

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The first medical-specific all-electric injection molding machine from Shibaura Machine Company, America will be introduced to the North American market during Plastec West 2024.

“For years, medical device manufacturers have been using our general purpose ECSXIII machine to mould a variety of products,” said Chad Clawson, Key Accounts Sales Manager for Medical Casting/Molding Division at Shibaura. “Our new medical-specific machine offers the same speed and functionality as other ECSXIII models, with enhancements that are ideal for medical moulding and cleanroom environments.”

These enhancements include:

  • Plated platens to control particulates and contamination
  • Stainless steel guarding and panels ideal for cleanroom environments
  • Raised frame for easy access to clean below the machine
  • Special NFS H1 Certified lubrication grease
  • Extended ejector stroke (+30 mm)

At Plastec West, Shibaura will use the new EC110SXIII medical machine to produce medical pipettes. Fully integrated with the EC110SXIII will be a Mold-Masters hot runner controller and Mold-Masters water manifold system, which are available as optional add-ons.

The latest addition to Shibaura’s popular ECSXIII series of all-electrics, the new medical machine delivers fast injection speeds and dry cycle times, ensures longer mould life and provides uniform clamping force, for greater productivity, flexibility and versatility.

The machine also features the same user-friendly V70 controller built into all ECSXIII models, making it easy for operators to decrease mould set up time, optimise cycle times, analyze part defects, troubleshoot defects and more.

Included with the new machine is a full year subscription to machiNetCloud, Shibaura’s exclusive industrial IoT service providing manufacturers with remote, real-time access to machine data so they can control validated processes for molded components anytime, from any location.

The new medical-specific EC110SXIII is currently available in 110 US tons, with larger sizes to be available in the future.

ABN uses SterCube VELOX outdoor unit for Grade D nuclear cleanroom

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ABN Cleanroom Technology, a provider of pre-engineered cleanroom solutions for industries such as healthcare and pharma, has reached the end phase of constructing a new SterCube VELOX outdoor cleanroom unit.

The project entails a SterCube VELOX with multiple hot labs and QC labs on the inside.

SterCube VELOX is a mobile cleanroom solution for outdoor use, meant for high-end studies at nuclear sites, so it is often called a Lab2Cube.

The classification of this cleanroom is cGMP Grade D.

To create a VELOX, ABN Cleanroom Technology configured several SteriCube compartments to become a fully functional cleanroom area with all needed utilities for a critical nuclear environment such as CDA, O2, N2, and Denim Water.

Jo Nelissen, CEO of ABN Cleanroom Technology, said: “The great thing about our SteriCube VELOX solutions, is that we never have to start our projects from scratch, but that we can configure our virtual and physical building blocks that are off-the-shelf available.”

“With this project approach, we are able to deliver a fully operational cleanroom and BSL on site in just 12 weeks -from quotation to hand-over to the customer,” Nelissen continued.

“SteriCube VELOX is currently one of our best-selling products due to its highly configurable and temporary character. We have previously installed multiple of these units on nuclear sites, which makes it a proven solution for operators working in that field,” Nelissen concluded.

The cleanroom is assembled in ABN Cleanroom Technology’s manufacturing hall and transported to customers in separate parts.

Further, as a result of its design for modularity and circularity, there was no waste of materials when separating the units for transport.

At the customer’s site, the separate parts were assembled back together after which ABN Cleanroom Technology’s Validation Department started its validation activities.

Also, a SteriCube always comes with an online monitoring system, which in this case was CleanConnect.

This allows the nuclear operator to always have insights in the parameters of the cleanroom area.

In addition, ABN Cleanroom Technology pointed out that in this type of working environment, safety is crucial. Therefore, measurements need to be real-time with alarms going on when environmental limits are exceeded.

LIFE places cleanroom order to work on next-gen Continuous Glucose Monitor

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Lifecare AS (LIFE), a clinical-stage medical sensor company, which is developing the next-generation Continuous Glucose Monitor (CGM), has disclosed that it has placed the purchase order for a cleanroom.

In LIFE’s investor communication, the company announced the launch of an automated production line by the end of Q2 2024. Also in the investor communication, the automated production line was set as a major milestone.

Joacim Holter, CEO of LIFE, said: “The cleanroom is now purchased as another step toward the company’s upcoming automated pilot production. The cleanroom will be delivered and installed in Q2 2024.”

Cleanrooms are always required where the airborne particles are likely to contaminate the final product.

LIFE’s cleanroom, which holds an ISO Class 7 standard, will ensure that the airborne particles are maintained at a very low concentration to not interfere with crucial functions of sensor components during sensor manufacturing.

The sensor components consist of micro and nano technologies sensitive to particles.

The airborne particles could potentially impact the functionality of the sensor by blocking the nano filtration layers and subsequent flow of the substances in and out of sensor cavities.

The cleanroom was planned and designed in 2023 by evaluation of various process maps of LIFE’s automated manufacturing equipment and is another step toward the product launch in the veterinary market.

In recent months, LIFE has made strategically important purchases of production equipment.

A purchase order has been made for Scanning Electron Microscope from the German company Carl Zeiss AG and software from the same supplier.

In addition, a purchase order has been placed for a BioScaffolder (BS 3.3) and a customised Nano-Plotter (NP 2.1) from the German supplier GeSiM mbH.

Both suppliers of this cornerstone equipment have confirmed delivery in Q2 2024.

Holter said: “This is the last important investment to facilitate automated pilot production in the next quarter. All the equipment will now arrive in Q2 within the deadlines,” Holter concluded.

ISPE announces speakers for 2024 Aseptic Conference

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Featured speakers at the 2024 ISPE Aseptic Conference will be health representatives from Australia, Europe, and the US.

The representatives from these national regulatory agencies will discuss current issues in aseptic processing from a technical perspective and the latest developments in aseptic and sterile manufacturing.

These featured speakers will also provide clarifications and weigh in on key learnings from the initial steps towards the implementation of Annex 1.

Attendees will have the opportunity to submit questions to the panellists.

The featured speakers are representatives from the following:

  • Austrian Agency for Health and Food Safety (AGES/Austria)
  • Regierungspraesidium (RP) Tübingen in Germany
  • Swissmedic in Switzerland
  • Therapeutic Goods Administration (TGA) in Australia
  • United States Food and Drug Administration (US FDA)

The confirmed featured speakers are:

Christina Meissner, GMP Inspector at the Austrian Agency for Health and Food Safety (AGES)

Meissner said: “As a representative of the Austrian Competent Authority, I will be reporting on the status of the implementation of Annex 1.”

“There will be specific examples of best practices, but also of areas where the industry needs to improve,” Meissner continued.

 

Daniel Muller, Head of GMP Inspectorate at Regierungspraesidium (RP) Tübingen in Germany

Muller said: “As a German regulator, I will be talking about our experiences in inspections since Annex 1 came into effect in August 2023.”

Muller will be discussing the areas where RP have seen good strategies of implementation, common hurdles for implementation, and where the industry has to improve.

Maria Löflund, Site Head Manufacturing Vienna at Takeda

Löflund said: “ISPE provides a great platform for exchanging knowledge and best practices with other companies on current and important industry topics.”

“I am looking forward to the 2024 ISPE Aseptic Conference in March and the valuable discussions on aseptic processing and implications of Annex 1 changes to the industry, as well as welcoming visitors to our Takeda production site in Vienna to share insights into our technologies and processes,” Löflund added.

 

Alexander Herzog, Secretary General of PHARMIG in Austria

Herzog said: “My talk will focus on the contribution of the pharmaceutical industry in Austria to world health.”

The 2024 ISPE Aseptic Conference will bring together leading professionals from several industries including:

  • Pharmaceutical and biopharmaceutical manufacturers
  • Technology providers
  • Academic scientists
  • International regulators

Vitech works with Airbus to design innovative air recirculation system for satellite cleanroom

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Viessmann Technologies (Vitech) has completed a state-of-the-art satellite manufacturing cleanroom in Madrid for Airbus.

The modular cleanroom solutions provider was chosen for the completion and commissioning of the new cleanroom, and it was executed in order to make the area ready for its qualification and handover.

The new build was completed in Getafe, close to Spain’s capital city Madrid.

Vitech encountered some specific challenges along the course of the build. These hurdles were the result of the need for 15m high ceilings, set levels of recirculation, and a short lead time.

The cleanroom needed to have a 15m ceiling. Therefore, Vitec installed more than 3000 sqm of ceiling grid system at over 15m. This area of wall and ceilings then had to be sealed to ensure tightness and correct pressure. “Panels for sound absorption have been added into the ceiling to minimise the noise from the complete ventilation system,” the company added.

The room also now contains six personnel airlocks with air showers, cleanroom doors and a conductive cleanroom floor.

The wall, floor, and ceiling system also integrated lights, sprinklers and exhaust air grids.

The ventilation system needed to create ISO Class 8 levels of cleanliness to meet manufacturing guidelines. Vitech worked with Airbus to design an innovative air recirculation system in order to do this.

The system is comprised of 10 recirculation units with H14 and AMC filtration systems, including adjustable flow velocity and direction.

The demands of all of these needs were compounded by a short lead time. “The project has been handed over in just over 26 weeks from the start date,” Vitech said.

LR Pure Systems chooses CAT to double its cleanroom capacity

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LR Pure Systems, a specialist in the field of high-tech solutions for ultra-high-purity gas and fluid systems, has doubled its cleanroom capacity at its site in Heimerdingen (Baden-Württemberg), Germany.

The additional ISO 6 Class cleanroom area enables the commissioning of another state-of-the-art system for cleaning components, such as those used in wafer processing or technical gas supply.

CAT Clean Air Technology supported  LR Pure Systems, its long-time partner with the implementation of this expansion project.

“The high requirements for the chemical cleanliness of the cleanroom in accordance with DIN EN ISO 14644-8 proved to be a challenge in the planning phase, and in the implementation phase above all the floor height of the existing building,” CAT Clean Air Technology said in a LinkedIn post.

“Repeatedly, pipes had to be rebuilt during ongoing production operations in order to optimally position the plenum and the filtration technology and to maintain the required height in the approximately 115 sqm cleanroom. The connection of the existing cleanroom systems also required coordination skills and flexibility from all those involved!”

MSA Safety opens Morocco PPE manufacturing facility

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MSA Safety, a safety solutions company, marked the grand opening of a new Manufacturing Operations centre in Chelalate, Morocco, with an official ribbon-cutting event.

The company’s newly constructed and larger facility will be home to the production of a variety of general personal protective equipment (PPE) product lines.

The new facility will also position MSA to better meet the growing demand for MSA safety products in the Europe, Middle East and Africa (EMEA) region.

MSA Safety has had a presence in Morocco since 2002 when the company acquired CGF Gallet of France.

Jose Sanchez, MSA Safety Vice President of MissionOPS, said: “Expanding our operation in Morocco is part of our strategy to invest in regions where we’re seeing growth and a demand for our safety products. By investing in a larger facility, we’re able to optimise our manufacturing footprint to better serve key markets in the EMEA region, support our growth goals for the product lines that are currently manufactured there, and maintain a high level of customer service.”

In 2021, the Morocco team won the John T. Ryan Sr. Award for Safety Excellence. An internal award created in honour of one of the company’s co-founders, it is presented annually to the associates of an MSA manufacturing facility who show exemplary dedication to the company’s culture of safety and the MSA mission.

Bob Leenen, Senior VP and President of MSA International said: “The confidence we have in our associates and the leadership team in Morocco is why we’re investing in this location. This new facility will provide a better work environment for our growing team and enhance our ability to meet the needs of our customers throughout the region.”

ColPro Technical Solutions completes cleanroom for Unica Building Services Venlo

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ColPro Technical Solutions has built a cleanroom in Katwijk (North Brabant) Netherlands on behalf of Unica Building Services Venlo.

Unica Building Services manages and maintains all building-related installations. The company coordinates the complete management and maintenance of buildings in combination with carrying out tests and inspections.

The wall panels were made in ColPro’s monoblock system on plinth construction in its factory in Almelo and installation was carried out by its own field service technicians.

Although it is a relatively small cleanroom with a lock, it has affected various components from walls including return panels and flush glass cassettes to ceiling systems and frames with doors equipped with a Maasland interlock system.

The panels were produced in the ColPro Technical Solutions factory in Almelo and installation was carried out by its own field service technicians and have an Advantica L-Control coating in white RAL 9010. Although it is a relatively small cleanroom with a lock, it has affected various components from walls including return panels and flush glass cassettes to ceiling systems and frames with doors equipped with a Maasland interlock system.

In a significant leap towards advancing cleanroom technology, ColPro Technical Solutions has recently unveiled its state-of-the-art cleanroom facility in Katwijk, Netherlands. The facility promises to be a game-changer in the realm of cleanroom solutions, catering to diverse industries with its advanced features and cutting-edge technologies.

 

CleanSpace unveils innovative new programme Clean Fit

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In a strategic move to redefine the speed to market of defining and developing the Cleanroom market, CleanSpace, a prominent leader in cleanroom solutions, today unveiled its innovative programme, Clean Fit. This pioneering initiative is set to forge synergies with regional developers, aiming to showcase the advanced design and functionality of a CleanSpace cleanroom within buildings that are presently on the lease market.

“Clean Fit is designed to make it easier for life science companies to visualize and achieve their ideal production environment,” said Glenn VandeGrift, President of CleanSpace. “Our partnership with developers not only facilitates this visualisation but also significantly reduces the financial barrier to entry for these companies, ensuring a smoother start-up phase.”

Through Clean Fit, prospective tenants, particularly those interested in spaces of 5,000 sqft or more, are provided with complimentary Basis of Design (BOD) drawings, test fit drawings, and initial construction sets. This value-added service is intended to save tenants substantial amounts of time and costs, thereby sustaining their cash flow during the crucial phase of establishment.

“Our vertically integrated approach is what sets CleanSpace apart,” said CEO George Wiker. “We manage every aspect from design to installation, which means our clients benefit from our efficiency and expertise. The Clean Fit program exemplifies our dedication to providing comprehensive solutions that meet the complex needs of the life sciences industry.”

Currently, there are two showcase cleanrooms under construction, located in Houston, Texas, and within the Historic Curtis Building in Philadelphia, PA. These strategic locations are expected to open for tours prior to the conclusion of 2023, marking a significant milestone in providing access to CleanSpace’s cutting-edge cleanroom technologies.

Board Advisor Ralph Melfi added: “By expediting the process of cleanroom integration for our clients, we’re not just accelerating their production timelines—we’re facilitating the advancement of critical therapies and products to the market. Clean Fit is a game-changer for the life sciences sector.”

The Clean Fit service aligns seamlessly with CleanSpace’s mission to support and enhance the growth of the life science industry. It provides a comprehensive look at the company’s cleanroom capabilities while eliminating complexities associated with setting up such sophisticated spaces.

CleanRooms International Selected by Instrumentum for Sterile Processing Cleanrooms

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CleanRooms International (CRI) – a leading manufacturer of state-of-the-art cleanroom solutions, is delighted to announce that it has been selected as the trusted partner to design and equip cutting-edge ISO 7 Sterile Processing Cleanrooms for Instrumentum.

Instrumentum is an outsourced provider of sterilisation services for surgical instruments in advance of surgeries, raising the quality of sterilisation and quantity of surgical instruments available for surgery centres and hospitals. The rapidly emerging service allows surgery centres and hospitals to focus their efforts on core competencies and their resources toward better patient care by outsourcing instrument sterilisation to a trusted, specialised service partner. Instrumentum established their new headquarters in The Research Park at Florida Atlantic University in Boca Raton, FL and is an emerging leader in this arena.

The ISO 7 Sterile Processing Cleanroom is a pivotal component of Instrumentum’s mission to uphold the highest standards of sterility, ensuring patient safety and health. CleanRooms International is dedicated to meeting this vital need by providing a custom cleanroom solution tailored to the exacting requirements of Instrumentum’s proprietary sterile processing solutions.

“We are honoured to complete the first project for Instrumentum, and to be chosen as their cleanroom partner for future expansion,” said Tim Werkema, President and CEO of CRI. “Our team is fully committed to delivering a cleanroom that not only meets but exceeds the stringent standards of sterile processing. We recognise the critical role of this cleanroom in ensuring patient safety and will spare no effort to provide a solution that matches the exacting needs of Instrumentum.”

“CleanRooms International is a trusted name in the cleanroom industry. We are proud to partner with CleanRooms International due to their commitment to quality and delivering a state-of-the-art cleanroom solution customised to our specific needs,” said Dan Johnson, CEO of Instrumentum. “The fact that they manufacture the majority of the cleanroom components in their builds was a determining factor during the evaluation process.”

This partnership between CleanRooms International and Instrumentum marks a significant milestone in the journey towards improving the standards for sterilisation services provided to the healthcare industry in the United States. Use of third-party sterilisation service companies has already become a normalised practice in several other countries around the world, and this partnership will now provide those services in the US.

Conducting the sterilisation process in a protected and certified environment that is built by CleanRooms International is empowering Instrumentum to deliver best-in-class medical device sterilisation services to surgery centres and hospitals and raise the bar for accountability in delivering “Sterile Every Time”.