January 6, 2022
Although domestic travel is slowly ramping up, companies may still consider virtual factory acceptance testing (FAT). FAT is an optional step in the life sciences’ process of purchasing factory equipment. However, a virtual FAT is not limited to the COVID-19 pandemic.
Typically, a team from the life sciences organization looks for proof of intended use in the equipment purchased prior to shipping to their location. Upon successful verification, the equipment is shipped from the equipment/system manufacturer. FAT visits allow life sciences companies to confirm that the equipment meets their design specifications. The equipment manufacturer may also do performance tests prior to shipment to help ensure the manufacturer that the equipment is performing in a way that will meet customer expectations.
Virtual factory acceptance testing (vFAT) makes virtual commissioning more accessible and efficient. Here, we do a deep dive into why you should opt for a vFAT when purchasing equipment.
Typically, only a core team of internal stakeholders travel for factory acceptance tests due to limited budgets and factory space. Reviewing the factory equipment virtually allows a much larger group of employees of your company to participate in this process. Using the vFAT process, you can include everyone that may add value to this process - from the CEO to interns, allowing all impacted members of your company to be involved in the testing process.
Additionally, inspecting and testing virtually allows for a much more iterative process. For example, if an engineer at your company has a highly technical question, the equipment vendor may need to research the answer. With vFAT, vendors and buyers can bring in additional team members to respond to questions and issues during the testing procedure and easily pause on certain vFAT aspects while information is gathered. This cannot be done when a team travels to the site and has limited time on-site to complete an in-person FAT process. Virtual factory acceptance tests also yield a video file that can be closely reviewed after the process and stored for reference.
Although costs should not be the sole driver of your manufacturing decisions, vFATs are very cost-effective. The average budget for a FAT visit is $40,000, according to Pharmaceutical Online. By conducting that process virtually, you’ll free up tens of thousands of dollars for other project areas. Furthermore, the high cost of traveling to another factory causes most companies to postpone FATs until all purchased equipment is ready.
For example, if a life sciences company purchased ten chemical synthesizers, but it takes four weeks for the vendor to manufacture the last two chemical synthesizers, the manufacturer must delay the FAT until all synthesizers are available to be evaluated. Meanwhile, most of their finished equipment is sitting in the factory unutilized. vFAT eliminates this bottleneck from your process by allowing you to schedule FAT meetings as each piece of equipment is ready for testing.
With in-person FAT, a limited number of personnel can huddle around equipment to view it up close. With virtual functionality testing, teams can set up multiple cameras around the equipment. This way, a room full of people can view it in real-time. Most factories will set up a camera specifically to show the human-machine interface (HMI), which lets vendor employees demonstrate specific operator tasks.
No matter the industry or task, introducing technology to a process can create shortcomings that were not previously present. Connectivity issues outside of your immediate control can lead to poor video quality that renders the meeting useless. Additionally, as is the case with all large virtual meetings, there is the potential for disengagement.
To avoid these issues and keep your vFAT meetings on track, we recommend that the vendor:
The buyer should also set up high-speed internet and a video-conferencing application to process intake from multiple cameras.
To avoid potential disengagement internally and on the vendor side, we recommend having members from the vendor and manufacturer on camera and splitting up the vFAT meeting into 45-minute sections with breaks in between. During these breaks, employees can discuss acceptance criteria amongst themselves and get refreshments.
If your interest in conducting virtual factory acceptance tests is piqued, you’ll need guidance to plan your first virtual FAT. Here at ProPharma, we offer Qualification Services tailored to your company’s needs. Our compliance and clinical experts are available to ensure that no question is left unasked or unanswered.
We also offer Good Manufacturing Practice (GMP) Lifecycle Methods consulting services. Our experts include chemists, microbiologists, pharmacists, and engineers with industry experience across various product and manufacturing environments. We partner with your manufacturer to ensure every aspect of manufacturing occurs in a GMP environment with proper controls in place.
Finally, we offer Process Validation Services for the design, qualification, and continued verification of manufacturing processes. As part of these services, we can help you choose appropriate equipment to achieve your desired outcomes. Contact our team today to learn more.
TAGS: Life Science Consulting
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