mRNA, Viral vectors

Simplify isolator qualification and avoid delays

Niamh Hanrahan

Technical Solutions Manager, Cytiva

Jun 2, 2026

Qualification is essential, but it doesn’t have to slow you down

Robotic gloveless isolators play a critical role in maintaining sterility assurance in modern aseptic manufacturing – and validating them isn’t optional. While these systems deliver major operational and contamination-control benefits, the qualification process can be complex and prone to delays if not managed well. Standardized designs offer a real opportunity to speed up timelines to GMP readiness. But to fully realize that speed advantage, qualification and validation activities must be planned and executed in a structured, risk-based way, ensuring focus remains on what is critical to product quality and patient safety. Decisions made during qualification do not only affect timelines, they can influence validation effort, inspection readiness, and operational performance long after GMP readiness is achieved.

Key activities in qualifying an isolator

Qualification demonstrates that your manufacturing process is capable, controlled and compliant with regulatory expectations. A key part of this is qualifying your equipment. You need to verify that it’s built and installed according to the design specifications and operates to the process requirements across all defined operating ranges. Also, you must show control of critical aspects of operations through qualification and validation over the lifecycle of the product and process.

The main activities are shown in Figure 1.

Fig 1. Overview of the qualification journey for an aseptic filling workcell. Performance qualification is done after the system is installed.

There are many activities to coordinate, which can be daunting without the right perspective. Cytiva enables customers to navigate this complexity by drawing on insights gained through global surveys and hands-on project support. This experience helps end-users anticipate common pitfalls, avoid compliance gaps, and move confidently toward GMP readiness.

For teams balancing qualification rigor with aggressive timelines, gaining speed to GMP filling requires careful planning and early alignment.

Tips for an efficient process

Integrate your planning

When installing an isolator at a new site that’s still under construction, be sure to factor in the potential impact of construction delays. These impacts can quickly cascade into qualification timelines, especially when a new facility and isolator are being qualified at the same time. It’s important to carefully coordinate all of the activities and resources.

Create a robust master plan that integrates the qualification activities with design and construction schedules, accounting for interdependencies such as utility installations required for equipment operation. Involve all relevant stakeholders early in the planning process to make sure that critical elements and risks are identified. Where possible, implement countermeasures to mitigate these risks. Proactive scheduling and contingency planning are essential to keep the project on track.

Unforeseen challenges are inevitable, but a detailed project plan and early risk identification can minimize their impact. Schedule disruptions don’t just affect timelines; they result in missed opportunities and financial losses. We can’t overstate the need for proper planning and preparation when you’re aiming for a smooth and successful qualification.

Lesson learned #1:

Pitfall: In one project, delivery and qualification planning progressed before facility readiness was fully confirmed. Critical utilities were unavailable, and ongoing site activities limited space for installation.

Impact: Site acceptance testing (SAT) was pushed out by more than four months, and the isolator required offsite storage after delivery – adding unplanned cost and pushing the start of qualification later than planned.

Takeaway: Treat facility readiness as a gating milestone. Confirm utilities, space availability, and site access before finalizing delivery dates to protect qualification timelines, control cost, and maintain project momentum.

Apply quality risk management

Even with strong planning, qualification efficiency depends on how well risk is understood and managed. A common issue we see—often with a substantial downstream impact—is limited upfront planning, driven by pressure to start production quickly. Take a formal, documented, science and risk-based approach, aligned with ICH Q9, to help define the appropriate scope of qualification from the outset. By identifying and evaluating risk early, you can anticipate potential issues before the isolator is even installed. And focus efforts where it matters most for product quality and patient safety.

Quality risk management shouldn’t be a one-time exercise. Consistent with ICH Q10 principles, it should be applied throughout the entire lifecycle, from design and installation through to routine manufacturing, ensuring that knowledge gained at each stage informs future decisions and continuous improvement.

Standardized workcells such as ours are efficient not just in operation but also in qualification. One of the key advantages is that you don’t need to reinvent the wheel when it comes to qualification. A standardized system allows a more consistent, risk-based qualification strategy.

Rather than relying solely on new testing, you can leverage existing knowledge from both vendor development work and performance data across the installed base. For example, eight companies with SA25 aseptic filling workcells across the globe aggregated their usage data from 2018 to 2021. Together, they published this data to show that the design of the workcell is effective at eliminating human risk to the aseptic process (1).

A traditional approach to installation qualification and operational qualification (IQOQ) might cover more scope than needed. In practice, this can lead to unnecessary duplication of testing that has already been successfully performed during vendor qualification or system development. By applying a risk-based approach, the scope of qualification can be adjusted to focus on critical aspects that have a direct impact on process performance and product quality. Cytiva enables execution momentum by providing robust testing protocols and applying good documentation practices (GDP) when executing the protocols.

An integrated qualification strategy, where vendor qualification activities are formally incorporated into the overall validation approach, helps eliminate redundant testing that doesn’t add value. This not only improves efficiency but also reduces risk to project timelines and resource availability.

Lesson learned #2:

Pitfall: In this example, a pitfall was avoided. Rather than developing qualification protocols from scratch, the project team leveraged existing vendor qualification frameworks.

Impact: By using qualification templates and protocols provided by Cytiva, the team reduced documentation effort, avoided redundant testing, and maintained focus on execution.

Takeaway: Start with proven vendor qualification frameworks. Early adoption of standardized templates and data can accelerate qualification, optimize resource use, and support faster progression to GMP readiness.

Focus on VPHP decontamination

One of the most critical—and often underestimated—steps in the qualification journey is validating the decontamination cycle. For systems like ours, this process is achieved through an automated vapor-phase hydrogen peroxide (VPHP) cycle. During qualification, tap into vendor knowledge and expertise to optimize cycle development and validation.

The goal of validation is to demonstrate a 6-log reduction of highly resistant Geobacillus stearothermophilus spores using biological indicators (BIs). Note that BI manufacturing is inherently variable and often comes with long lead times. Plan to make sure the BIs are available when you need them. Also, BIs require a seven-day incubation period, which should be factored into your project timeline along with buffer time for potential retesting if you don’t get the results you expect. Rushing validation activities can lead to errors or deviations that require long investigations, which will ultimately extend the overall project timeline. Instead, focus on developing a robust cycle during the development phase to derisk the validation process and set your qualification up for success.

Lesson learned #3:

Pitfall: Biological indicator (BI) logistics—ordering, handling, and storage—is often underestimated during planning.

Impact: In one real-world example, insufficient BI planning meant the original start date for cycle development wasn’t met. Improper storage of BIs led to unexpected positives, driving the need for repeated testing and further extending qualification timelines. Early schedule compression ultimately resulted in greater disruption and investigation effort later in the project.

Takeaway: Treat BI management as a critical path activity. Order BIs early, plan realistically for incubation and retesting, and store BIs strictly according to manufacturer specifications to protect data integrity and keep qualification on track.

Document everything and plan for reviews

As the quality assurance (QA) mantra goes, “If it wasn’t documented, it didn’t happen.” Documentation is a cornerstone of equipment qualification and a critical part of compliance. At the core of every facility is the contamination control strategy (CCS), which must be supported by complete, accurate, and well-maintained records. All test protocols, reports, deviations, and standard operating procedures (SOPs) should be meticulously documented, reviewed, and approved by QA.

Cytiva has developed qualification protocol templates and checklists to enable a more efficient qualification journey by reducing documentation effort, promoting consistency, and helping teams focus on execution rather than on recreating protocols.

One common pitfall during project planning is not allowing enough time to review and approve documents. Multiple stakeholders mean multiple rounds of reviews. Missing details can lead to a delay in execution or deviations. This review and approval can’t be rushed at the end of the project without a negative impact on quality and compliance. Build sufficient time for these activities into the project timeline to support smooth execution and a successful qualification process.

Lesson learned #4:

Pitfall: Documentation review was treated as a downstream activity rather than a critical path. The time required for drafting, reviewing, and approving qualification documents was underestimated during planning.

Impact: Slow internal review cycles prevented planned test execution and blocked progression to subsequent qualification phases. In one project, repeated pauses for document approval extended the overall qualification timeline and disrupted execution flow.

Takeaway: Recognize documentation review as a gating activity. Build realistic timelines for document preparation, cross functional review, and QA approval early in the project to maintain qualification momentum without compromising quality or compliance.

Rely on vendor resources and training

Execution readiness depends not only on documents, but also on the people responsible for following them – and how effectively the work is planned from the outset. As one user insight highlighted: "Establish your cross-functional team early, map out everything you’ll need (materials, resources, calibrations, instruments, documentation, etc.), and create a detailed project plan." This early alignment ensures the right resources with the right skill sets are available at the right time and reduces downstream inefficiencies.

It’s essential to train operators during qualification to make sure they’re equipped to perform the aseptic process simulation (APS) and future production runs. Familiarity and confidence in operating the system contribute to smooth, consistent performance and help reduce the risk of issues during both qualification and routine operations.

Supporting steps, such as material transfer, are often overlooked in equipment qualification. These require well-defined SOPs and targeted training. Incorporating these elements early in the planning phase prevents disruptions and operational challenges later.

When knowledge isn’t transferred, requalification efforts can suffer. Rather than over-relying on external consultants, building internal capability during qualification strengthens long-term operational resilience and supports more effective lifecycle management. While these practices can be implemented internally, many teams choose to leverage vendor experience to reduce risk and accelerate execution.

Lesson learned #5:

Pitfall: Internal capability for VPHP qualification wasn’t developed during the initial project, with heavy reliance placed on external consultants.

Impact: When annual requalification was required, the site lacked the in house expertise to execute VPHP activities independently. This resulted in additional vendor training, unplanned costs, and avoidable disruption to routine operations.

Takeaway: Build internal expertise as part of the initial qualification strategy. Investing in knowledge transfer and operator capability early supports efficient requalification, reduces reliance on external support, and strengthens long term operational resilience.

You may also be interested in looking at real-world examples to understand how qualification and validation are achieved in practice, such as how Emergent Biosolutions implemented their SA25 workcell. You can also view an infographic to see how NorthX and White Raven Annex 1 GMP certification.

How Cytiva can help with qualification and more

We have designed a comprehensive, standardized qualification package grounded in insights from installations around the world. With this package, you don’t need to start from scratch or repeat common mistakes. Engaging with Cytiva early in the project allows customers to apply this experience from the outset, rather than reacting to issues later. It also reduces the risk of missing critical steps, provides access to our protocols and data, and supports consistency across projects and sites.

Our support extends well beyond system installation and qualification. We also provide regulatory inspection support to help customers prepare for and successfully navigate agency interactions. We focus on education and audit readiness, supporting teams to understand the quality by design (QbD) principles behind their system, organize supporting documentation, and confidently explain their qualification and contamination control strategies. Cytiva stays engaged with project teams through the final stages, helping customers approach inspections with clarity, confidence, and fewer surprises along the way.

References

1. McCall J, Bernard N, Gadient K et al. Environmental monitoring for closed robotic workcells used in aseptic processing: Data to support new regulatory approaches. AAPS PharmSciTech. 2022;23(6):215. doi: 10.1208/s12249-022-02360-3.