In Simple Terms
A new tool is designed to help medicine and vaccine makers check the air in sealed production areas without interrupting production to bring in supplies. The company says it can support air sampling for up to four hours at a time, once the setup has been checked. The goal is to make routine monitoring easier while keeping the protected area sealed.
The Challenge Is Bigger Than Taking a Sample
When making medicines and vaccines, it is not enough for the finished product to be safe. Manufacturers must also reduce the chance that microbes will reach sensitive stages of production. That is why facilities monitor the air, surfaces and processes around a product, especially when work takes place inside isolators or barrier systems designed to limit the transfer of contamination between workers and the production environment. But monitoring itself requires tools and supplies to enter these protected spaces without weakening the protection they provide.
On 21 October 2026, Particle Measuring Systems (PMS), a provider of contamination-monitoring solutions, announced the launch of BioCapt Single-Use STS. The product addresses a specific practical challenge: getting air-monitoring supplies that collect microbes into isolators and restricted-access barrier systems without requiring additional disinfection when they are brought inside. The idea is to maintain environmental monitoring while keeping production moving.
Active air samplers help determine whether biological particles are present in the air in a production area. They work by drawing a measured volume of air through a purpose-built device, which collects particles on a suitable medium. The resulting sample can then be handled according to the facility’s established testing procedures. The newly announced product is an air-microbe collection tool based on the BioCapt Single-Use Microbial Impactor platform, which the company says is already well established.
In a sealed environment, the challenge goes beyond choosing a sampler. Everything brought into the area must pass through a transfer route that preserves the separation between the inside of the isolator and the outside. If introducing extra supplies calls for additional cleaning, sterilization or disinfection steps, that can mean more preparation and more time—and may require changes to the workflow. The focus here, then, is on how consumables are delivered into the production environment, not simply on replacing one measuring device with another.
This need becomes more apparent when monitoring requirements change during a production run, or when a facility wants to keep sampling for longer without opening a transfer route that involves more manual handling. Each additional step in moving equipment can require operational planning, while the isolator must continue to function as a barrier between its interior and the surrounding environment. That is why a dedicated transfer route, designed to meet sterile-transfer requirements, matters.
How the Transfer System Works
BioCapt Single-Use STS combines microbial sampling tools prepared for sterile transfer with Getinge’s DPTE-BetaBag transfer technology, which the company says has been validated. The combination allows consumables to pass through rapid transfer ports, or RTPs. These ports are designed to move materials across the boundary without compromising the barrier between the isolator and the outside environment.
STS stands for Safe Transfer Solution. The name describes the product’s intended role: preparing and transferring sampling supplies in a sterile configuration that can be introduced through a transfer port. Maintaining the isolator’s integrity still depends on using the designated transfer system and applying it correctly at the facility. The announcement should not be taken to mean that other control measures are unnecessary or that a facility can skip its own operational qualification and validation.
PMS describes the supplies as ready for sterile transfer and says the configuration has been validated. The package also includes comprehensive validation documentation to support implementation and regulatory compliance. Such documents can help facility teams understand the configuration’s characteristics and assess whether it suits their procedures. They do not, however, mean that every production site can adopt the system in the same way. Each site remains responsible for evaluating and implementing it under its own conditions and approved procedures.
Less Manual Handling with Single-Use Equipment
The company compares this approach with conventional monitoring using Petri dishes. According to PMS, the single-use product reduces handling, lowers the risk of contamination from repeated contact, supports continuous monitoring, and does not need to be cleaned or sterilized after use as reusable equipment might. These are operational benefits claimed for the product, not quantified results showing how much contamination or time it saves.
Petri dishes are widely used in many kinds of microbial testing, but managing them in a sealed environment may involve steps for bringing them in, handling them, collecting them and transferring them out, depending on the procedure. The single-use design aims to simplify part of this cycle by providing consumables in a sterile-transfer configuration. This may reduce the number of times some items need to be handled directly, while the facility’s other requirements for sampling, analysis and documentation remain in place.
Single-use does not mean that monitoring becomes fully automated or that staff no longer need to follow procedures. Microbial monitoring still depends on planning where and when samples are taken, handling each sample appropriately, and reviewing results in the context of manufacturing operations. Based on the published information, the product offers a way to introduce supplies suited to the system and continue monitoring the air, while reducing the need to clean and sterilize the single-use equipment.
Four Hours at 25 Liters per Minute
The announcement’s most prominent operating figure is that the system can be used for up to four hours at a flow rate of 25 liters per minute, after validation. This describes an operating capability under validated conditions; it is not a general guarantee that every run will last four hours in every setting. The flow rate indicates the volume of air passing through the sampler over a given period, allowing a facility to plan an active monitoring window based on the configuration that has been evaluated.
An extended operating period may be useful when it is important to maintain monitoring through a continuous production stage, or when quality teams want broader time coverage within a sampling plan. But the value of any operating duration depends on whether it fits the monitoring objective, the facility’s internal validation procedures and the conditions of the process. The company therefore emphasizes an important qualification: operation for up to four hours at 25 liters per minute is subject to validation, not a feature that should be assumed without testing or approval.
PMS says additional consumables can be introduced during production without stopping operations or starting extra disinfection cycles. This is intended to avoid a trade-off between keeping manufacturing underway and strengthening monitoring. Rather than having to wait for a planned shutdown to bring in more supplies, a facility can use the system to transfer them during operation, while preserving the isolator’s integrity and following the designated transfer route.
Monitoring as Part of a Contamination-Control Strategy
Air monitoring matters as part of a broader contamination-control system, not as a stand-alone activity. Manufacturers need several ways to understand the environment around a product and determine whether their controls are working as intended. Active air monitoring helps build a picture of the biological particles collected over a defined period, while decisions about the production environment draw on the full set of procedures and data used by the facility.
The announcement links the product to evolving regulatory expectations and specifically mentions the European Good Manufacturing Practice guidelines’ Annex 1, known as EU GMP Annex 1. This places the system in the context of growing attention to contamination-control strategies in sterile manufacturing. Mentioning the annex does not mean the product itself guarantees compliance. A facility must still apply the relevant quality, validation and documentation requirements, and evaluate each tool as part of its complete system.
Giulia Artali, PMS’s Global Product Manager for Microbiology and Sterility, says manufacturers face increasing pressure to strengthen contamination control while maintaining productivity. In effect, she says the tool gives operations teams more flexibility to adjust monitoring plans inside isolators as production needs change, without adding unnecessary complexity to the workflow. The intended benefit is as much about organizing day-to-day work as it is about the technical aspects of sampling.
Who Might Use It?
According to the company, the system is designed for pharmaceutical, biotechnology, vaccine and radiopharmaceutical manufacturing environments. These fields share a need to monitor sensitive production settings, although the details of their processes and requirements differ. The stated range of applications includes isolators and restricted-access barrier systems, where maintaining separation between areas is part of how work is organized.
The system may be particularly relevant to facilities that need to add monitoring supplies while production is underway, or that want to support active air sampling for an extended period within validated limits. But being part of the pharmaceutical sector alone does not determine whether the product is suitable. Facilities would need to consider compatibility with their existing transfer ports, how their isolators operate, their monitoring plan, documentation requirements and site-specific validation procedures.
The company offers the product in a validated sterile-transfer configuration, along with expanded validation documentation intended to help facilities implement it and support compliance requirements. In regulated applications, documentation is not a minor detail: it helps build a record of what was evaluated and how the tool may be incorporated into procedures. Still, the announcement provides no comparative cost figures, quantified reduction in contamination or results from independent trials. The stated benefits therefore remain tied to the company’s description of the product’s design and intended use.
What the System Adds—and What the Announcement Does Not Prove
The main addition is the combination of a single-use microbial impactor with a sterile-transfer system that passes through a rapid transfer port. The aim is to let facilities introduce extra monitoring supplies while production continues. The company presents the approach as a way to reduce handling, limit contamination risks from handling, support continuous monitoring and avoid cleaning and sterilizing the single-use tool. It also cites an operating period of up to four hours at 25 liters per minute, subject to validation.
The published information does not include results from an independent comparative study or specify a percentage reduction in contamination or a numerical improvement in productivity. Nor does it detail the validation protocols or the conditions under which the operating duration was tested, or provide detailed performance data from different sites. It is therefore more accurate to treat these points as specifications and benefits stated by the company, which each facility should assess through its own technical review and procedures.
The broader principle is that monitoring tools should fit into manufacturing operations rather than needlessly complicate or interrupt them. If consumables can be introduced in a way that preserves the barrier, reduces handling steps and provides a validated operating period, that may help quality and production teams organize monitoring as part of ongoing work. Ultimately, suitability depends on validation results and real-world implementation at each facility.
The Bottom Line
BioCapt Single-Use STS is designed to address a clear operational challenge in sterile pharmaceutical manufacturing: bringing air-monitoring supplies into isolators and barrier systems without interrupting production or requiring an extra disinfection cycle. It combines microbial collection tools prepared for sterile transfer with Getinge’s DPTE-BetaBag technology, using rapid transfer ports while preserving the isolator’s barrier.
PMS says the single-use product reduces handling, supports continuous monitoring and does not need cleaning or sterilization after use. It can operate for up to four hours at 25 liters per minute after validation. The system is aimed at pharmaceutical, biotechnology, vaccine and radiopharmaceutical manufacturing, and comes with validation documents intended to support implementation and regulatory requirements, including those related to EU GMP Annex 1. Each facility will still need to assess the system under its own conditions: it may simplify part of monitoring, but it does not replace validation or the need to manage a complete contamination-control strategy.