Feliza Mirasol is the science editor for 

Feliza Mirasol

Discussion with Chris Murphy of Environmental Specialties about the design and critical role or walk-in chambers in bio/pharma development and manufacturing.

INTERPHEX 2025: Use of Walk-In Chambers for Bio/Pharma Development and Manufacturing

Walk-in chambers are critical infrastructure in pharmaceutical facilities, primarily used for product storage under highly controlled environmental conditions, such as temperature and/or humidity, says Christopher Murphy, director, Global Business Development and Service Customer Support, Environmental Specialties. Murphy sat down with the PharmTech Group at INTERPHEX 2025 to discuss the role walk-in chambers play in bio/pharmaceutical development and manufacturing as well as sustainability.

Given the stringent requirements of pharmaceutical products, these chambers are often large-scale, resembling warehouses. However, their energy-intensive nature poses sustainability challenges.

“Proper design of a walk-in chamber can contribute to sustainable practices. It is no secret that a walk-in room, because of the exacting conditions it has to create, can be an energy hog. It can be a drain on utilities. But if properly designed, and if the manufacturer asks the correct questions about the use of the space, then it can be engineered in a way that minimizes that impact and runs at optimum performance,” Murphy says.

As Murphy explains, proper engineering and design can mitigate energy consumption, optimize performance, and extend the chamber’s operational lifespan, thereby reducing maintenance costs and environmental impact. He also points out that thoughtful construction minimizes the need for frequent replacements and spare parts, promoting long-term sustainability.

Meanwhile, Murphy remarks that the current market dynamics and economic conditions influence investment in such technologies, raising questions about whether the observed market fluctuations are temporary or indicative of long-term trends. At INTERPHEX 2025, he is keen to explore strategic partnerships with emerging companies because such partnerships can facilitate knowledge exchange and help stakeholders align technological capabilities with market needs. Murphy emphasizes that the industry must balance precision storage requirements with sustainability and economic considerations to ensure long-term operational efficiency and environmental responsibility.

Attendees can visit Environmental Specialties at Booth #2864 at INTERPHEX 2025, which runs April 1–3 in New York City.

Christopher Murphy, Director, Global Business Development & Service Customer Support, Environmental Specialties

Christopher Murphy currently serves Environmental Specialties as director of global business development and service customer support. For the past 12 years, he has been vice-president or president of companies serving regulated markets. He has a proven track record of driving double-digit annual sales growth. In his previous role, he joined a company that had been flat for the decade prior to his arrival and was able to generate a 23% compound annual growth rate over his four-and-a-half-year tenure, doubling the company’s revenue. Prior to that, he achieved title of president while leading growth from $2 million to $50 million in annual sales. Murphy has been responsible for the launch of numerous innovative products, including being a co-author of a patent for a predictive maintenance technology related to components within medical diagnostic Instruments in his most recent role. Murphy has extensive experience in global business, having managed teams in China, led distributors and agents across Asia and Europe, and performing business development efforts, including mergers and acquisitions, globally.

Articles

Sitting down with the PharmTech Group at INTERPHEX 2025, Christopher Murphy, director of Global Business Development and Service Customer Support at Environmental Specialties, discusses the design and critical role of walk-in chambers in the bio/pharmaceutical industry.

INTERPHEX 2025 video interview with Iwata Label USA discussing practical security benefits of functional labels for parenteral drugs.

INTERPHEX 2025: How Functional Labeling Can Protect Parentals in Vials and Syringes

Sitting down with the PharmTech Group at INTERPHEX 2025, William Wainwright, business development manager at Iwata Label USA, a division of Japan-based IL Group, highlights the need for improved protection of pharmaceutical vials and syringes, particularly through functional labels. Previously, vials were not sufficiently protected due to cost considerations, but after conducting recent studies, the company began to understand the financial and human costs of breakage. Instead of overhauling packaging, however, Wainwright asserts that functional labels can reinforce existing vial infrastructure by preventing breakage, cracks, and leaks.

“We traditionally have not protected the vials as stringently as we should and could, just simply for cost reasons. It's just now that we've done more studies on the costs associated with broken vials, or even the human cost of negative effects to healthcare workers, [that] the need for heightened protection on vials has increased,” Wainwright says in the interview. “And then with functional labels, what they can do is, instead of reimagining the whole packaging system, you can use existing packaging infrastructure, [such as] the traditional vials, but then add on a specialty label that helps protect the vial from breakage, cracks, or seepage of the internal contents.”

He goes on to explain that, for syringes, the primary concern is material-induced drug migration, which can alter the chemical composition of highly potent medications. Preventing migration is critical to maintaining drug integrity. Another key function of these labels is shielding vial and syringe contents from light exposure, which can degrade pharmaceutical compounds. Functional labels, therefore, serve a dual purpose: physical protection and preservation of drug stability.

Wainwright also expresses enthusiasm for engaging with industry leaders at INTERPHEX 2025 to encourage broader adoption of these specialized labeling solutions within the pharmaceutical sector.

Attendees can visit Iwata Label USA at Booth #1362 at INTERPHEX, which is being held on April 1–3 in New York City.

William Wainwright, Business Development Manager, Iwata Label USA, a division of IL Group

William Wainwright is business development manager for Iwata Label USA, a division of IL Group, and a provider of precision labeling solutions for global pharmaceutical and healthcare companies. The company’s portfolio includes good manufacturing practice-compliant roll-on and shrink-tack labels featuring value-added benefits, such as tamper evidence, protection against breakage, and light-shielding properties, as well as specialty constructions whose functions range from reliable adhesion in cryogenic applications to detachable elements for ease of medical recordkeeping.

William Wainwright, business development manager at Iwata Label USA, discusses the practical security benefits of functional labels at INTERPHEX 2025.

AES Clean Technology (AES), a provider of modular cleanroom solutions, announced on April 1, 2025 that it has officially launched Omni ASCENT, a next-generation off-site manufactured (OSM) vertical utility solution that is designed to optimize the flexibility and efficiency of cleanrooms, at INTERPHEX 2025. The company said in a press release that the launch of this OSM solution is a significant advancement toward cleanroom utility integration (1). INTERPHEX is being held on April 1–3 in New York City.

Omni ASCENT is built on the foundation of AES’s Omni utility raceway, which is a system that integrates critical cleanroom utilities into a modular, adaptable framework. Omni ASCENT enables strategic placement of utilities anywhere on the cleanroom floor. In comparison, traditional systems limit layout options and pose challenges to accessibility, according to AES in the press release. Omni ASCENT enables greater flexibility, efficiency, and safety, and allows pharmaceutical and biotech facilities to optimize space and workflow without having to compromise compliance, according to the company.

“Omni ASCENT is a direct response to the evolving needs of modern cleanroom environments,” said Shawn Reniker, senior vice-president of Operations, AES Clean Technology, in the release (1). “By eliminating the need for wall or ceiling-mounted utilities, we are giving manufacturers the freedom to configure layouts more efficiently, enhance accessibility for maintenance and operations, and accelerate deployment—all while maintaining the highest industry standards.”

Omni ASCENT is designed for rapid deployment; it arrives fully assembled and ready for installation, which can be done in under half a day. This shortened deployment significantly reduces downtime. Meanwhile, its strategic utility placement enhances ergonomics while creating a safer workspace by eliminating unnecessary ladder use and tripping hazards. In addition, the new system can be easily integrated with existing Omni raceway solutions. This compatibility facilitates a streamlined transition for both new cleanroom builds and facility retrofits, according to the press release.

“Last year, the CleanLock Module reinforced the demand for smarter, more flexible cleanroom solutions. Omni ASCENT builds on that momentum, providing even greater adaptability in utility integration and ensuring that facilities can scale efficiently without redesigning their infrastructure,” said Chris Miller, chief executive officer, AES Clean Technology, in the release.

 the CleanLock Module, which is an airlock solution for cleanrooms that has been engineered to minimize the risk of contamination. The module minimizes contamination risk by integrating AES’ proprietary cleanroom finishes, patented lighting, predictable airflow patterns, and advanced door controls. These features offer the advantage of being integrated into any facility without delay. The module allows for secure transition of people and materials entering and exiting cleanrooms.

"We are thrilled to introduce the CleanLock Module airlock to the market," said Grant Merrill, AES chief commercial officer, in a press release at the time of the CleanLock Module launch in 2024 (2). "This product addresses the critical need for maintaining ultra-clean environments in industries such as pharmaceuticals, biotechnology, and medical device manufacturing. With its state-of-the-art technology and precision engineering, the CleanLock Module will set a new standard for contamination control and efficiency in design and construction execution."

Attendees can visit AES at Booth #2509 at INTERPHEX 2025.

1. AES Clean Technology. AES Cleanroom Technology Introduces Omni ASCENT: A Breakthrough in Cleanroom Utility Integration at INTERPHEX 2025. 

. April 1, 2025.
2. AES Clean Technology. AES Clean Technology Sets New Standards for Cleanliness and Efficiency in Cleanrooms with the Launch of Its CleanLock Module. Press Release. April 16, 2024.

The Omni ASCENT, officially launched at INTERPHEX 2025, is a next-generation off-site manufactured vertical utility solution aimed at optimizing the flexibility and efficiency of cleanrooms.

AES Clean Technology Introduces OSM Cleanroom Utility Solution at INTERPHEX 2025

On April 1, 2025, BioPure, a provider of single-use solutions and part of Watson-Marlow Fluid Technology Solutions (WMFTS), announced that it has refined the manufacturing of its single-use sanitary connector, BioClamp, to offer sustainability benefits to users. The company will showcase the connector at INTERPHEX 2025, occurring April 1–3 in New York City.

BioPure, which introduced the first single-use sanitary bioclamp for bioprocessing in 1998, according to a company press release (1), has optimized BioClamp in terms of its design and its manufacturing process. Under the new manufacturing process and new design, the connector is 13% lighter in weight compared to the previous BioClamp model. The adoption of advanced automated assembly has also resulted in 26% less carbon dioxide emissions during manufacturing across the full lifecycle of the product (1). BioClamp securely attaches sanitary fittings and plays a crucial role in single-use critical fluid transfer lines.

“From enhanced production to shipment, use in a bioprocess and end-of-life disposal, BioClamp is designed for sustainability while maintaining the highest quality standards,” said Mark Lovallo, product manager for WMFTS, in the press release (1). “BioClamp is efficiently manufactured, pre-assembled, and packaged at our global network of state-of-the-art Class 7 cleanrooms, which gives users of our sanitary bioclamp confidence in quality and sustainability as they scale up their production. These facilities are ISO14001 certified and powered by renewable energy.”

An additional upgrade to the bioclamp is an advanced ergonomic hinge that makes it easier to close and simplifies the set-up of an assembly process, allowing for quick changeovers. Other features and benefits include:

reduced distortion on polymeric fittings when subjected to heat

suitability for sterilization using autoclave and gamma irradiation

suitability for either single-use or multiple-use applications

reliable availability of global manufacturing and supply network.

WMFTS has the goal of reaching net-zero for its scope 1 and 2 emissions (i.e., emissions that are in its direct control) and reducing scope 3 emissions (i.e., those emissions that the company is indirectly responsible for, up and down its value chain) by 2030. Optimizing the manufacturing process for the BioClamp connector is a significant step toward that goal.

Speaking with Nicole Hunter, head of Global WMArchitect at WMFTS last year at 

 the PharmTech Group discussed the importance of optimizing fluid-handling workflows in the bioprocessing space and the efficiencies that single-use technologies (SUTs) can offer for biomanufacturing (2).

“One of the main reasons to have really good workflows is to reduce the risk in your process. You want to … safeguard your therapeutic during the process and expedite getting that drug product to the patient,” Hunter said in the interview (2).

Hunter noted that the big advantages SUTs bring are flexibility and adaptability to bioprocessing. “What [SUTs] have been able to do—in moving away from stainless-steel systems—is to allow for quick changeover between drug products. One facility can make multiple drug products really easily; the manufacturing systems can be quickly assembled for the different drug products and changed out as, and when, needed. [SUT] also reduces risk of cross contamination because you're literally using that assembly for that drug product and then changing to another one,” she explained in the interview (2).

Attendees can visit WMFTS at Booth #2753 at INTERPHEX 2025.

1. Watson-Marlow Fluid Technology Solutions. 

BioPure Advances Manufacturing of BioClamp to Bring Significant Sustainability Benefits to Its Users

. Press Release. April 1, 2025.
2. Mirasol, F. 

Single-Use Technologies Reinforce Fluid-Handling Workflows (INTERPHEX 2024)

With advanced manufacturing, BioPure’s BioClamp connector is manufactured to be 13% lighter than the previous model, resulting in a 26% reduction in carbon dioxide emissions across the full lifecycle of the product.

WMFTS’ BioPure to Showcase Single-Use Bioclamp with Refined Manufacturing at INTERPHEX 2025

Beckman Coulter Life Sciences, a provider of laboratory automation and innovation and an operating company of Danaher Corporation, has launched the CytoFLEX mosaic Spectral Detection Module, the industry’s first modular spectral flow cytometry solution, the company announced on March 18, 2025 (1).

The CytoFLEX mosaic Spectral Detection Module offers substantially greater fluorescence sensitivity when connected to the CytoFLEX LX or S Flow Cytometers. The solution addresses challenges with dim and complex multicolor experiments because it can detect nanoparticles as small as 80 nm. The instrument provides two unmixing algorithms and up to 10 autofluorescence channels, with up to 88 detection channels. As a result, richer data can be generated from spectral analysis that can help untangle the complexities of biological systems and diseases faster. It also allows for a nuanced understanding of immune cell subsets and their functions and interactions by simultaneously detecting multiple markers.

“As a central feature of the CytoFLEX platform, this innovation is focused on pairing ease-of-use with powerful, sensitive acquisition technology to remove the intimidation encountered in many flow cytometry instruments,” said Matthew Goff, product manager, Beckman Coulter Life Sciences, in a company press release. “Investigators can now easily switch between their true conventional detection system and this advanced spectral detection system, while maintaining a familiar sample management and user experience, all without having to invest in a separate instrument. Along with experimental continuity and evolution offered by a more flexible approach, this delivers a unique solution for sustainability needed by many institutions.”

Compared to conventional flow cytometry (2), spectral flow cytometry acquires the full emission spectrum of each antibody-associated fluorophore across all lasers, rather than just measuring the peak of emission. This advanced ability delivers a more detailed and precise characterization of cellular properties, which can then advance the understanding of complex biological systems and diseases within each sample compared to older, traditional approaches, according to the company in the release.

The CytoFLEX mosaic spectral detection module runs on a unique algorithm that is capable of improving resolution compared to other available methods. It also offers unmixing accuracy checks for ensuring efficiency. Accompanying the instrument is the CytExpert software, used in spectral cytometry to reduce the need for extensive training, which can thus speed up the transition to spectral technology. The module also comes with tools to ease the full spectral workflow and offers access to the FluoroFinder panel builder and a Cytobank premium license that provide all the tools needed to transition from sample preparation to analysis of complex spectral data in an easy manner.

“I found the software very easy to learn and was able to start my first experiments in only a few hours,” said Tamar Tak, coordinator of the Flow Cytometry Facility at Leiden University Medical Center, in the press release. “A feature I really like is that it allows me to do an extensive QC [quality control] of the unmixing. You get a plot with all the normalized spectra of your fluorochromes and a table with similarity indices. This allows me to see if a tandem dye has degraded, or perhaps the wrong antibody was added. The autofluorescence settings are another highlight, allowing flexibility depending on your samples—from human tissue to complex samples of microorganisms.”

The new module is available in two configurations, the CytoFLEX mosaic 88 for the CytoFLEX LX Flow Cytometer and the CytoFLEX mosaic 63 for the four-laser CytoFLEX S Flow Cytometer.

Beckman Coulter Life Sciences Launches Industry-First Modular Spectral Flow Cytometry Solution

. Press Release. March 18, 2025.
2. McKinnon, K. M. Flow Cytometry: An Overview. 

The CytoFLEX mosaic Spectral Detection Module offers up to 88 channels for detection.

Beckman Coulter Life Sciences Launches Modular Spectral Flow Cytometry Module, First of Its Kind in Industry

FDA’s Center for Drug Evaluation and Research (CDER) issued a 

 to India-based Aspen Biopharma Labs (Aspen) in March 2025 following its inspection of the company’s facility in Malakpet Village, Rangareddy, in Hyderabad, India. The inspection took place Sept. 16–21, 2024. According to the warning letter, FDA inspectors found significant deviations from current good manufacturing practice (CGMP) in the production of APIs (1).

“Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B),” FDA stated in its March 5, 2025 letter (1).

Deviations found during the inspection include, but are not limited to:

a failure in the design and construction of the buildings and facilities used to manufacture the API in a way that minimizes potential contamination and facilitates appropriate cleaning, maintenance, and operations

failure to demonstrate that the company’s manufacturing process can manufacture an API in a reproducible manner while meeting its predetermined quality attributes and failure to adequately validate written procedures for the cleaning and maintaining equipment

failure to provide records, either originals or copies, that are readily available and promptly retrievable during the retention period

failure to design a documented, ongoing stability testing program that monitors the stability characteristics of API and to use the results for confirming appropriate storage conditions as well as for retest or expiry dates (1).

FDA’s warning to Aspen is the latest in a series of warning letters the agency has issued this year to India-based API manufacturers. In February 2025, the agency separately issued warning letters to 

 (Tyche) regarding deviations from CGMP for APIs (2,3).

In the warning letter to Jagsonpal, FDA based its observations on an inspection conducted on March 20, March 27, and April 3, 2024 at the company’s facility in Bhiwadi Dist., Alwar, in Rajasthan, India. During its inspection, the agency observed a failure of the company’s quality unit to exercise its responsibility to ensure compliance with CGMP in the manufacture of the API produced at the company’s contract facility. In addition, the inspector was denied entry by persons present at the site upon arrival on March 15, 2024, only to be granted entry on March 20, 2024; however, during inspection, access to requested documents was limited. Finally, a (b)(4) drug was manufactured at an unregistered facility and was not listed by the company as required under 

)Title 21, Part 207.41(a) (4), which caused the (b)(4) drug to be misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o).

“[F]ailure to provide current listing information in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p),” FDA stated in the letter (2).

Meanwhile, the warning letter to Tyche was based on an inspection conducted at this company’s Sarpavaram, Kakinada, India, manufacturing plant on Aug. 12–16, 2024. In this letter, the FDA inspector observed several deviations, including but not limited to:

a failure to record all quality-related activities at the time these are performed

failure to clean equipment and utensils to prevent contamination or carry-over of any material that can alter the quality of the APIs produced beyond the official or other established specifications

failure to test the identity of each batch of incoming production material (3).

Warning Letter: Aspen Biopharma Labs Private Limited

, March 5, 2025 (accessed March 27, 2025).
2. FDA. 

Warning Letter: Jagsonpal Pharmaceuticals Limited

 Title 21, 207.41(a) (Government Printing Office, Washington, DC), 

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-207/subpart-D/section-207.41

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.