Cleanroom news

AES Cleanroom Technology, a leading provider of modular cleanroom design, manufacturing, and construction solutions for the life sciences and biopharmaceutical industries, is celebrating 40 years of advancing cleanroom technology at INTERPHEX 2026, highlighting four decades of innovation and its ongoing focus on future facility development.

 

 

Founded in 1986, AES has built its reputation on delivering integrated cleanroom solutions, emphasizing speed and quality throughout the project lifecycle.

“The work has only gotten more consequential,” said Chris Miller, CEO of AES Cleanroom Technology. "The therapies being developed today are unlike anything the industry has seen, and the environments that enable them have to be built right and built fast. Our clients are tackling some of the hardest scientific challenges in human history under real cost and schedule pressure. Our job is to make sure the facility never becomes an obstacle. That's what we show up to do every day." 

Four decades of growth

"Since pioneering the pre-engineered modular cleanroom system in the United States, AES has designed, manufactured, and built more than 4,000 facilities, representing more than 10 million square feet of controlled environment space, all made in the USA. The company's single point of accountability spans concept, design, manufacturing, construction and ongoing service.

AES has earned 16 International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Awards, more than any other cleanroom company, and has supported clients including Genentech, CRISPR Therapeutics, Bristol-Myers Squibb, and Novartis."

Where Breakthroughs Are Built

AES cleanrooms have enabled the development and manufacture of groundbreaking Advanced Therapy Medicinal Products (ATMPs), including:

• the first FDA-approved autologous cell therapy (Provenge, 2010)

• the first FDA-approved gene therapy (Luxturna, 2017)

• the first FDA-approved CAR-T cell therapy (Kymriah, 2018)

• the first FDA-approved tumor-infiltrating lymphocyte therapy (Amtagvi, 2024)

• the first FDA-approved T-cell therapy for solid tumors (Adaptimmune, 2024)

 

“This is not just construction,” Miller said. “It is the infrastructure that supports the path from scientific breakthrough to patient access.”

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Are Supply Chain Bottlenecks Impacting TPE Tubing Procurement?

Supply chain disruptions have become a persistent challenge for pharmaceutical procurement teams. Thermoplastic elastomer (TPE) tubing, a critical component in single-use bioprocessing systems, faces growing demand alongside increasing supply vulnerabilities. 

By Emily Newton 

Geographic concentration of production facilities, trade disruptions and fluctuating availability create procurement obstacles that can delay research timelines and compromise production schedules. Understanding these challenges and implementing strategic sourcing approaches can help procurement teams secure reliable access to the high-purity, chemically resistant tubing their applications require.

The Growing Challenge of Sourcing TPE Tubing in Pharma

The thermoplastic elastomer tubing market is experiencing consistent year-over-year growth, with projections indicating expansion from approximately $2.8 billion in 2023 to $5.4 billion by 2033. This surge reflects increasing adoption in pharmaceutical and bioprocessing applications.

However, production of critical pharmaceutical components remains geographically and industrially concentrated, creating vulnerabilities that ripple through global supply chains. Since a few pharmaceutical companies produce specific drugs, individual business decisions have widespread, prolonged effects on global availability.

Trade disruptions and fluctuating supply exacerbate these challenges, making reliable procurement increasingly difficult for pharmacists, biologists and life science professionals. However, TPE is still a superior tubing material for pharmaceutical applications.

TPE tubing offers several technical advantages that make securing a stable supply mission-critical:

●     High material purity: Nontoxic and latex-free formulations meet medical-grade application requirements.

●     Temperature versatility: Flexibility across broad temperature ranges enables diverse applications.

●     Cost efficiency: It’s generally more economical than silicone alternatives, making it ideal for high-volume, single-use applications.

●     Sterilization compatibility: It’s compatible with rigorous sterilization methods, including autoclave and gamma irradiation.

Strategies for Building a Resilient TPE Tubing Supply Chain

Mitigating these risks requires proactive supply chain strategies. Industry professionals can look to real-world case studies for insight.

Partnering With a One-Stop-Shop Supplier

A supplier with a broad portfolio and deep expertise reduces dependency on multiple vendors, simplifying procurement. With subject matter expertise and a broad portfolio of single-use tubing solutions, Sentinel Process Systems addresses pharmaceutical procurement challenges. Its approach emphasizes material purity, chemical resistance, weldability, sealability and regulatory compliance.

It helps customers quickly identify optimal products, and its expertise eliminates time spent evaluating specifications independently. This one-stop-shop model simplifies the procurement of single-use tubing solutions that meet USP Class VI and ISO 10993 biocompatibility standards, minimizing the administrative burden of managing multiple vendor relationships and purchase orders.

Taking Control With Vertical Integration

Companies that implement in-house manufacturing reduce dependency on external suppliers and become more resilient to supply chain disruptions. Venair's approach to single-use assemblies demonstrates this strategy in action. Through vertical integration, the company controls its manufacturing process from raw material sourcing through final assembly. This approach provides greater quality control, faster response times and reduced vulnerability to third-party supply interruptions.

Embracing Material Diversification

When suppliers offer diverse material options, procurement teams gain flexibility against single-material shortages. Freudenberg Medical's strategic expansion illustrates this approach. By diversifying its TPE tubing options, the company offers customers alternatives when specific formulations face availability constraints. Pharmaceutical manufacturers can pivot between materials without compromising application requirements or production timelines thanks to this diversification strategy.

Exploring Expanded Distribution Networks

Working with manufacturers who maintain strong, broad distribution partnerships improves accessibility and reduces lead times. The Teknor Apex and Nexeo partnership exemplifies this strategy. By establishing expanded distribution networks, the partnership increased TPE availability across North America. Broader distribution insulates procurement teams against regional supply disruptions and provides alternative sourcing channels when primary routes face delays.

Implementing a Closed-Loop Supply Chain

Forward-looking strategies, such as sustainability and recycling, also enhance supply resilience. DuPont's approach to implementing a closed-loop supply chain demonstrates the circular economy model. While the case study focuses on silicone, the principle applies equally to recyclable polymers like TPE. Reducing dependency on raw material supply chains enables closed-loop systems to support environmental objectives.

Frequently Asked Questions About TPE Tubing Procurement

Professionals should refer to these frequently asked questions for more insights.

What are the benefits of using TPE tubing over silicone?

Compared to silicone, TPE tubing offers superior abrasion, tearing and solvent resistance. Greater flexibility and softness make it easier to handle during assembly processes. Silicone materials often cost more to manufacture due to complicated raw material procurement and manufacturing processes, making TPE a more cost-effective choice for high-volume single-use applications. The cost differential becomes particularly significant in large-scale bioprocessing operations where single-use systems may require extensive tubing runs.

What is the chemical compatibility of TPE tubing?

With excellent chemical resistance to acids, bases and polar solvents, TPE tubing is ideal for sanitary fluid transfer in pharmaceutical applications. High compatibility with sealing and welding processes enables secure connections in single-use systems without compromising chemical integrity. This chemical resistance ensures that tubing maintains its structural integrity throughout process runs, preventing contamination and maintaining product purity.

What regulatory standards should TPE tubing meet?

TPE tubing for pharmaceutical applications should meet USP Class VI and ISO 10993 standards for biocompatibility of medical device materials. These certifications ensure the material is suitable for contact with biological fluids and tissues without causing adverse reactions. Compliance with these standards is essential for regulatory approval in pharmaceutical manufacturing and biopharmaceutical research applications.

Anticipating and Addressing Future Procurement Problems

A multifaceted strategy combining supplier partnerships, vertical integration, material diversification, expanded distribution networks and sustainable closed-loop systems provides the strongest defense against future supply chain disruptions.

No single approach eliminates all risk. However, procurement teams that implement multiple strategies simultaneously build resilience against the geographic concentration and trade vulnerabilities affecting the availability of thermoplastic elastomer tubing. Proactive planning ensures reliable access to the critical components that support research and production.

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Genomes reveal five E. coli 'armor' types behind most multidrug-resistant bloodstream infections

                                                            Image designed by Tim Sandle

The first large-scale genetic study of E. coli's protective armour has identified the five capsule types that are responsible for 70% of all multidrug-resistant bloodstream infections in Europe. Researchers, including those at the Wellcome Sanger Institute, the University of Oslo, and their collaborators, analysed over 18,000 bacterial genomes from samples across all continents to investigate E. coli's armour and find new ways to penetrate it. 

Provided by Wellcome Trust Sanger Institute 

The study, published in Nature Microbiology, uncovered 90 different types of protective capsules, of which only 34% had been previously documented. The team also identified the capsule types that enable the bacterium to have the highest invasive potential, meaning it can transition from a harmless gut resident to a dangerous bloodstream invader.

By providing a blueprint of the armor that each E. coli strain has, this research can help in designing targeted vaccines and new treatments that can combat the most dangerous strains of E. coli while minimizing harm to beneficial strains of E. coli gut bacteria.

Science and microbiology gifts via Babbling Bacteria 

Escherichia coli (E. coli) is the leading cause of bloodstream infections worldwide. Most strains of E. coli are harmless and commonly found in the gut, however, if the bacterium gets into the bloodstream or the urinary tract, it can cause infections that range from mild to severe, particularly in people with a weakened immune system.

As an added challenge for health care providers, antibiotic resistance has become a frequent feature of such infections. Rates of antibiotic resistance in E. coli vary globally and, in the UK, over 40% of E. coli bloodstream infections are resistant to a key antibiotic.

Some bacteria, such as E. coli, have protective capsules that help shield the bacteria from the immune system and certain treatments, influencing the bacteria's ability to cause infections. Each bacterial strain has a different capsule makeup, and the capsules have markers, called antigens.

These antigens are often used as targets for new vaccines and treatments. However, for effective therapies to be developed, researchers need to know which capsule commonly causes the infection.

Traditional methods of mapping E. coli capsules are labor-intensive and uncommon. To address this, the team at the Sanger Institute and their collaborators genetically analyzed 18,000 E. coli samples. This allowed them to create the first digital database mapping capsule type and E. coli strain. They were then able to determine how common each type is using samples from nearly 8,000 people, ranging from newborns to those over 80 years old.

They found that capsule types are much more diverse than previously thought, mapping 90 different types, including 69 that had not been previously documented. The team also noted that different capsules were common in high-resource settings, such as the UK, compared to less industrialized regions such as Malawi and Pakistan.

For example, the researchers found that five specific capsule types (K1, K5, K52, K2, and K14) account for over 50% of all E. coli bloodstream infections and urinary tract infections across the UK, Norway, and France. Furthermore, a slightly different set (K1, K5, K52, K2, and K100) is responsible for 70% of multidrug-resistant E. coli infections in Europe.

While two of these (K1 and K5) do cause infections globally, there is more diversity in the strains that cause serious infections in low and middle-income countries than in Europe.

Due to these differences, the researchers highlight the importance of global data in future research, especially around drug and vaccine development, as the bacterial capsule types being targeted would vary depending on where the individual lived.

The team also found that E. coli has the ability to swap the genes that encode the capsule, sharing the information to build different types of armor between them.

Dr. Rebecca Gladstone, first and corresponding author at the University of Oslo, said, "By creating a digital library from over 18,000 bacterial genomes, we can see the true complexity of how E. coli protects itself, and how this armor is encoded in the genes. This research has expanded our scientific map from just a handful of known bacterial shields to a comprehensive database of 90 unique types, including nearly two-thirds that were previously unknown.

"Ultimately, this database provides the missing blueprint to identify strains most likely to cause serious infections, and design targeted vaccines and treatments to stop these."

Professor Jukka Corander, senior author at the Wellcome Sanger Institute and the University of Oslo, said, "This new research enables us to identify the strains of E. coli that are the biggest threats to human health. With this database, we can now see the bacterial capsule types that are prevalent in different countries, whether they cause serious infections, or if they are resistant to treatments.

"What our research also shows is the stark differences between capsule groups found in different regions, highlighting the need for systematic and standardized global data collection. Especially as we have found that E. coli can trade the genes for their protective shields between different genetic lineages.

"Understanding how these bacteria, especially the most drug-resistant ones, swap their coats, and having the global data to track this, is crucial for staying one step ahead of them in the fight against serious bloodstream infections."

Dr. Trevor Lawley, co-author at the Wellcome Sanger Institute, said, "Our microbiomes are made up of thousands of bacteria, and while the majority of these are beneficial, some strains can cause infections if they get into the bloodstream, such as E. coli.

"Large-scale population studies, such as the Baby Biome study, that provide a high-resolution view into the microbiome are essential for understanding the risk associated with certain bacterial strains, the genetic tools they use to cause infections, and how often they are found in the population.

"Understanding and tracking the E. coli strains that are most able to use their protective shield to move into the bloodstream and cause infection allows for the development of future targeted treatments while minimizing the harmful effects on the microbiome."

Publication details

Identification of transporter-dependent capsular K loci associated with invasive potential of Escherichia coli, Nature Microbiology (2026). DOI: 10.1038/s41564-026-02283-w

Journal information: Nature Microbiology 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

The billion-year reign of fungi that predated plants and made Earth livable

Image designed by Tim Sandle
 

Fungi may have shaped Earth’s landscapes long before plants appeared. By combining rare gene transfers with fossil evidence, researchers have traced fungal origins back nearly a billion years earlier than expected. These ancient fungi may have partnered with algae, recycling nutrients, breaking down rock, and creating primitive soils. Far from being silent background players, fungi were ecosystem engineers that prepared Earth’s surface for plants, fundamentally altering the course of life’s history. 

New research from Okinawa Institute of Science and Technology.

Complex multicellular life -- organisms made of many cooperating cells with specialized jobs -- evolved independently in five major groups: animals, land plants, fungi, red algae, and brown algae. On a planet once dominated by single-celled organisms, a revolutionary change occurred not once, but at least five separate times: the evolution of complex multicellular life. Understanding when these groups emerged is fundamental to piecing together the history of life on Earth."

Emergence here was not simply a matter of cells clumping together; it was the dawn of organisms, where cells took on specialized jobs and were organized into distinct tissues and organs, much like in our own bodies. This evolutionary leap required sophisticated new tools, including highly developed mechanisms for cells to adhere to one another and intricate systems for them to communicate across the organism, and arose independently in each of the five major groups.

The difficulties of dating evolutionary divergence

For most of these groups, the fossil record acts as a geological calendar, providing anchor points in deep time. For example, red algae show up possibly as early as about 1.6 billion years ago (in candidate seaweed-like fossils from India); animals appear by around 600 million years ago (Ediacaran fossils such as the quilted pancake like Dickinsonia); land plants take root roughly 470 million years ago (tiny fossil spores); and brown algae (kelp-like forms) diversified tens to hundreds of millions of years later still. Based on this evidence, a chronological picture of life's complexity emerges.

There is, however, a notable exception to this fossil-based timeline: fungi. The fungal kingdom has long been an enigma for paleontologists. Their typically soft, filamentous bodies mean they rarely fossilize well. Furthermore, unlike animals or plants, which appear to have a single origin of complex multicellularity, fungi evolved this trait multiple times from diverse unicellular ancestors, making it difficult to pinpoint a single origin event in the sparse fossil record.

Reading the genetic clock

To overcome the gaps in the fungal fossil record, scientists use a "molecular clock." The concept is that genetic mutations accumulate in an organism's DNA at a relatively steady rate over generations, like the ticking of a clock. By comparing the number of genetic differences between two species, researchers can estimate how long ago they diverged from a common ancestor.

However, a molecular clock is uncalibrated; it can reveal relative time but not absolute years. To set the clock, scientists need to calibrate it with "anchor points" from the fossil record. Given the scarcity of fungal fossils, this has always been a major challenge. The OIST-led team addressed this by incorporating a novel source of information: rare gene "swaps" between different fungal lineages, a process known as horizontal gene transfer (HGT).

While genes are normally passed down "vertically" from parent to child, HGT is like a gene jumping "sideways" from one species to another. These events provide powerful temporal clues," he says. "If a gene from lineage A is found to have jumped into lineage B, it establishes a clear rule: the ancestors of lineage A must be older than the descendants of lineage B.

By identifying 17 such transfers, the team established a series of "older than/younger than" relationships that, alongside fossil records, helped to tighten and constrain the fungal timeline.

A new history for an ancient kingdom

The analysis suggests a common ancestor of living fungi dating to roughly 1.4-0.9 billion years ago -- well before land plants. That timing supports a long prelude of fungi-algae interactions that helped set the stage for life on land.

Fungi run ecosystems -- recycling nutrients, partnering with other organisms, and sometimes causing disease. Pinning down their timeline shows fungi were diversifying long before plants, consistent with early partnerships with algae that likely helped pave the way for terrestrial ecosystems.

This revised timeline fundamentally reframes the story of life's colonization of land. It suggests that for hundreds of millions of years before the first true plants took root, fungi were already present, likely interacting with algae in microbial communities. This long, preparatory phase may have been essential for making Earth's continents habitable. By breaking down rock and cycling nutrients, these ancient fungi could have been the first true ecosystem engineers, creating the first primitive soils and fundamentally altering the terrestrial environment. In this new view, plants did not colonize a barren wasteland, but rather a world that had been prepared for them over eons by the ancient and persistent activity of the fungal kingdom.

The research paper reference is:

Lénárd L. Szánthó, Zsolt Merényi, Philip Donoghue, Toni Gabaldón, László G. Nagy, Gergely J. Szöllősi, Eduard Ocaña-Pallarès. A timetree of Fungi dated with fossils and horizontal gene transfers. Nature Ecology, 2025; DOI: 10.1038/s41559-025-02851-z 

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Understanding cleanroom changing room microorganisms

 

Changing rooms act as critical control points within pharmaceutical manufacturing facilities, functioning as microbial airlocks that limit personnel‑borne contamination entering classified processing areas. This study presents a five‑year comparative analysis (2022–2025) of microorganisms recovered from changing rooms and adjacent corridors, spanning cleanroom Grades D, C, and B. 

 

Environmental monitoring data—comprising surface contact plates, settle plates, and active air samples—were analysed and microbial profiles were evaluated. Across all areas, Gram‑positive cocci dominated, especially Micrococcus, Kocuria, and coagulase‑negative Staphylococcus, consistent with human skin flora. Grade D changing rooms showed the highest overall bioburden and organism diversity. 

 

Progressive reductions in microbial burden were observed as personnel transitioned through Grade C into Grade B areas. However, opportunities for improvement in gowning, cleaning, and moisture control were identified. This study provides a comprehensive dataset relating to pharmaceutical changing‑room microbiota and offers a reproducible framework for microbial profiling, trending, and benchmarking across cleanroom facilities.

To access, see:  https://www.ejpps.online/post/comparative-analysis-of-pharmaceutical-facility-changing-room-microbiota 

 

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Regulatory updates

 

The US Food and Drug Administration (FDA) has issued a draft guidance entitled ‘Computer Software Assurance for Production and Quality Management System Software’. Aimed at medical device manufacturers - check this out and other recent regulatory updates: https://www.rssl.com/insights/life-science-pharmaceuticals/issue-42-pharmaceutical-regulatory-roundup/ 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Pharmaceutical Resources

 See what Merck has to offer in terms of knowledge and resources, here.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)