Digital cleanroom cleaning management – ensuring efficient work and facilitating GMP compliance.
Digital cleanroom cleaning management – ensuring efficient work and facilitating GMP compliance.
TL;DR
Digitalization of cleanroom cleaning (CRC) management involves the use of software and other digital tools to capture data and streamline cleanroom cleaning operations by automating their management. Digitalizing CRC management provides a centralized hub where tasks and schedules can be managed, and data can be collected and analyzed. Going digital with a platform like MyCellHub can help cleanroom operators to increase efficiency and accuracy, stay compliant with safety standards, and avoid costly errors or omissions.
Introduction
Are you managing or operating cleanrooms? Urgently looking to maximize the efficiency and accuracy of your work? Want to stay compliant with industry-recognized protocols and safety standards?
Then you’ll want to stick around to learn how digitalization speeds up and safeguards the quality of your cleanroom cleaning processes.
In this article, you’ll discover:
- How new technologies can reliably boost cleanroom cleaning (CRC).
- What CRC management digitalization entails, and its practical benefits.
- A real-world case of successful digital CRC management by our customer, TRU.
Let’s kick things off with the current state of affairs and the challenges cleanroom cleaning operators face.
The challenges of cleanroom cleaning management
Cleanroom cleaning (CRC) is becoming increasingly important due to the rapid advancements in technology and growing demand for pharmaceutical, biotech and high-tech products that are often manufactured in a cleanroom. As such, cleanroom cleaning plays an integral role in the manufacturing process of these therapeutics. During cleaning, operators must follow a stringent cleaning procedure, which is typically guided by multistep and conditional instructions. Any errors or omissions could have (potentially major) downstream consequences. Throughout this process, operators are also responsible for proper documentation.
The CRC process itself is strictly controlled and regulated, both internally and externally. The external regulatory bodies provide standards for cleanroom management, such as ISO 14644 or EU Good Manufacturing Practice (GMP) Annex 1. For life science companies, GMP production regulations safeguard the quality and safety of the products.
For the operators tasked with ensuring regulatory compliance, this means spending a large chunk of their days manually filling out paperwork, managing data and compiling reports.
As a CRC manager, you carry an even greater responsibility. You supervise the cleaning process, the paperwork, and your team of lab technicians. You schedule, plan, manage, and direct. You ensure your team executed and recorded everything correctly, often without having direct control of on-site operations. And industry developments only add to your duties instead of lightening the load.
The rapidly advancing technology in cleanrooms paired with complex manual procedures makes real efficiency harder and harder to achieve. It also leads to skipped tasks, missing signatures, and lost documents. A seemingly minor mistake can result in substantial time and budget going to waste.
As the complexity of cleanroom cleaning technology grows and operations scale up, this error-prone way of working becomes increasingly unsustainable.
Going digital will help your organization alleviate these issues.
At this point, you might be thinking that we haven’t told you anything you didn’t already know.
You might have questions like: what does “going digital” even mean? How does digitalizing prevent these same problems from popping up? What tangible benefits can I expect?
Perhaps you’re already on the digital CRC management bandwagon and have trouble convincing those around you.
If this sounds like you, read on!
Digitalization to the rescue
To digitalize means to start using software or other digital tools to capture data that used to be analog or paper-based, and streamline and optimize the use of that data. In this context, digitalization means improving cleanroom cleaning operations by automating their management. Similar changes have already been introduced in many other settings – let’s illustrate this with a simple example: road navigation.
For nearly a century, paper maps were the gold standard. Using them meant stopping our car on the side of the road, searching for our location on the map, and remembering the route.
After the turn of the century, traveling became a lot less tedious. Digitalization had arrived, and GPS took over as the go-to road navigation solution.
Nowadays, almost nobody uses paper maps anymore because GPS does things paper maps never could. It tells us where we are in real-time and shows us what to do next instantly.
It also analyzes and reports many aspects of our driving in real time. For example, we know where and how far away our destination is, as well as our estimated time of arrival. Access to online information even accurately judges the traffic.
Today, this well-validated system is the gold standard we rely on.
We chose this example because it translates directly to CRC management. CRC digitalization means that the cleanroom cleaning operators use software with optimized protocols and schedules and interactive instructions instead of physical paper copies.
Like GPS, the software instantly shows the cleaning schedule, evaluates progress, and presents the next steps. You don’t have to stop, search for the instructions, and figure out what has and hasn’t been done yet.
And that's just the tip of the digital CRC management feature iceberg.
When implemented correctly, a digital CRC management solution serves as a single centralized hub where you manage tasks and schedules, prepare and schedule masterplans, collect and analyze data, and supervise compliance with regulations – while being as intuitive as the paper alternative. Solutions can even include real-time monitoring, automated reporting, and cloud-based data hosting (bypassing the hassle of on-premises servers).
So how does doing these things in a digital environment translate into tangible benefits for you and your CRC operations?
Well, stick around and discover how digitalizing your CRC management helps you mitigate risk, streamline compliance, and optimize your workflow.
Benefits of digital cleanroom cleaning management
Mitigate risk
If you’re only familiar with manual CRC management, it might be hard to notice just how risky a paper-based workflow is. Misplacing documents such as cleaning records, or forgetting to sign them off, are just two of numerous issues that can arise in the daily life of a CRC operator.
On the other hand, digital CRC management removes these issues from the equation and ensures processes are followed correctly.
With digital workflows, each step is traceable and can be monitored in real-time. The instructions for the operators are interactive, ensuring they perform all their tasks in the correct way and order. Not ‘ticking off’ a task will not only stop access to further instructions, but also trigger a warning and require the operator to log a comment, therefore safeguarding error-free operations.
Additionally, digital record keeping and reporting guarantees they are safely stored in a virtual space. They remain easily accessible online, so forgetting them in the car or at home is a nuisance of the past. But risks are not the only thing that is reduced with digitalization. It also means that you’ll have much less work to do to comply with regulations.
Streamline compliance
Managing a cleanroom involves regular audits that benchmark your compliance with regulations. Although they’re necessary to enforce quality standards, they can feel burdensome. Especially if you’re victim of the widespread misconception that paper-based management is the most reliable.
The truth is that digitalization offers functions that are well beyond the bounds of manual workflows and brings your cleanroom closer to audit-ready. At all times.
A digital solution makes standardizing operations easy by ensuring everyone accesses a clear set of procedures and protocols. This, along with built-in data collection, significantly lowers the risk of inconsistencies in the cleaning process and facilitates compliance with GMP and ISO norms. The CRC data records are also useful during audits, as they can serve as evidence of adherence to regulatory requirements. An added bonus: digital records are much easier to organize, catalog, search through, and filter, which fast-tracks the audit preparation process.
Finally, any deviation from the cleaning plan can be instantly reviewed by management – remotely, and without delays.
With risk mitigation and compliance streamlining out of the way, it’s time to talk about the exciting stuff: improving cleanroom efficiency by optimizing your workflow.
Optimize your workflow
Operating even just a single cleanroom costs thousands of euros a day, so operating them efficiently is paramount. That's why one of the most praised features of digital CRC solutions is the ability to optimize your workflow easily.
What does this mean in practice?
With the MyCellHub CRC management platform, you can get ahead of the curve and secure your competitive advantage. Our cloud-based system provides access to all data in real-time. This gives you complete control of your process as it’s performed, and lets you manage and schedule your masterplans easily.
The platform is also a synchronized system, meaning the system synchronizes between the platform users: cleanroom managers, cleaners, operators, owners, and others. The result: easy communication, reporting, and the ability to adjust your workflow together with all stakeholders.
Long-term data recording unlocks new possibilities as well. With smart data collection, you gain additional insights into your workflow, such as identification of trends and bottlenecks. Moreover, you can perform data analysis easily using fully automated reporting.
On paper, digital CRC management certainly makes a convincing case.
But we can imagine you thinking: how does it fare out in the field?
The short answer: remarkably well!
The long answer: we suggest reading the real-life use case of TRU, a leading Belgian cleanroom cleaning company, below.
CRC digitalization in practice – use case
Meet TRU
TRU is a Belgian cleanroom cleaning enterprise founded in 2019 and is known in the industry for its remarkable expertise. Vanessa Morini, TRU's co-founder and CEO, boasts years of experience in the sector. During her time in the pharmaceutical industry, Vanessa experienced firsthand how inefficient and error-prone manual documentation review is. As such, digitalizing TRU’s workflow was a high priority for her.
“I started looking for a company that could help us implement a digital workflow,” says Vanessa. “But I knew I needed someone that would do it in compliance with the GMP regulations. From the start, system validation was crucial for us. Otherwise, we can’t serve our customers who undergo regular audits.”
With these requirements in mind, TRU started the collaboration with MyCellHub.
Digitalizing TRU’s operations with MyCellHub
MyCellHub’s solution is a comprehensive platform that allows the user to fully automate cleanroom cleaning paperwork, starting from creating masterplans and scheduling tasks to automatic GMP reporting and analysis. The platform is intuitive and fully operational from the start, while its highly customizable settings make it a flexible tool.
“It’s an off-the-shelf product that a client can also tweak according to their needs,” says Antoine Jacquot, MyCellHub’s Sales Manager. “These traits make it easy to integrate the platform into client’s processes, without overwhelming them with too much novelty.”
At TRU, MyCellHub’s service is adapted to TRU’s client's specific needs. First off, the continuous monitoring of GMP compliance is made possible through the access to all digitally stored documentation. Additionally, scheduling functionality was implemented to adapt the plan to the client's requirements.
Another crucial feature of MyCellHub’s platform is that it also provides TRU’s cleaners with interactive instructions, making the workflow more dynamic and productive. “This proves beneficial for the technical team as they have less paperwork and interacting with protocols on a screen is more pleasant. Not having to deal with tedious paperwork has done wonders for employees’ morale,” observes Antoine.
Efficiency improvements and cost reductions are two key reasons why clients choose to go digital with their CRC management. The resulting profit increases are more than worth it. Don’t believe us? Then I suggest you keep on reading!
Cleaning smarter, not harder – the real-world benefits
One of MyCellHub’s clients decided to calculate their savings after switching to the digital management system. They discovered that a single site operated by a 15-cleaner team reduced time spent on documentation by 43%, in just a year. They saved over €41,000 and more than 2,080 working hours by replacing pen and paper with MyCellHub’s software. In total, 1,087 sheets of paper were saved thanks to the digital documentation system.
TRU still uses manual workflows with some clients. “They are not yet convinced because paper documentation means you have a hard copy. It’s tangible, you can hold it in your hands and feel like you’re in control,” admits Vanessa. “They don’t realize that the level of reliability and efficiency is much higher in the digital setting.”
Working simultaneously in two different setups, digital and manual, provides TRU with the unique opportunity to compare them in a real-life setting. The advantages of digitalization are clear to Vanessa and the team. Not only does it increase efficiency in cleaning, but it also facilitates simple and fast reporting and enables process optimization. These improvements give TRU a competitive edge and allow them to provide cost-effective services without compromising on their exceptional quality.
Conclusion
The benefits of switching to digital CRC operations are substantial. It can significantly reduce the risk of errors, streamline regulatory compliance, and help you optimize your CRC workflows – saving a lot of time and money in the process.
Despite this, hesitance across the CRC industry is still high. Digitalization may still be regarded as complex by some. After all, it does require buy-in from the team, learning new procedures, and trusting a new management system.
So, what should you keep in mind to smooth a digital transition?
To ensure the integrity and faultlessness of your new digital CRC management, always choose an expert-made solution validated by successful implementation in other companies. Following this simple rule will guarantee that your system will be trustworthy and will boost your efficiency.
People were hesitant to switch from maps to GPS as well. Do you see anyone navigating with maps now? Let’s digitalize your cleanroom cleaning process with MyCellHub!
Still hesitant to go digital ?
TL;DR
Digitalization of cleanroom cleaning (CRC) management involves the use of software and other digital tools to capture data and streamline cleanroom cleaning operations by automating their management. Digitalizing CRC management provides a centralized hub where tasks and schedules can be managed, and data can be collected and analyzed. Going digital with a platform like MyCellHub can help cleanroom operators to increase efficiency and accuracy, stay compliant with safety standards, and avoid costly errors or omissions.
Introduction
Are you managing or operating cleanrooms? Urgently looking to maximize the efficiency and accuracy of your work? Want to stay compliant with industry-recognized protocols and safety standards?
Then you’ll want to stick around to learn how digitalization speeds up and safeguards the quality of your cleanroom cleaning processes.
In this article, you’ll discover:
- How new technologies can reliably boost cleanroom cleaning (CRC).
- What CRC management digitalization entails, and its practical benefits.
- A real-world case of successful digital CRC management by our customer, TRU.
Let’s kick things off with the current state of affairs and the challenges cleanroom cleaning operators face.
The challenges of cleanroom cleaning management
Cleanroom cleaning (CRC) is becoming increasingly important due to the rapid advancements in technology and growing demand for pharmaceutical, biotech and high-tech products that are often manufactured in a cleanroom. As such, cleanroom cleaning plays an integral role in the manufacturing process of these therapeutics. During cleaning, operators must follow a stringent cleaning procedure, which is typically guided by multistep and conditional instructions. Any errors or omissions could have (potentially major) downstream consequences. Throughout this process, operators are also responsible for proper documentation.
The CRC process itself is strictly controlled and regulated, both internally and externally. The external regulatory bodies provide standards for cleanroom management, such as ISO 14644 or EU Good Manufacturing Practice (GMP) Annex 1. For life science companies, GMP production regulations safeguard the quality and safety of the products.
For the operators tasked with ensuring regulatory compliance, this means spending a large chunk of their days manually filling out paperwork, managing data and compiling reports.
As a CRC manager, you carry an even greater responsibility. You supervise the cleaning process, the paperwork, and your team of lab technicians. You schedule, plan, manage, and direct. You ensure your team executed and recorded everything correctly, often without having direct control of on-site operations. And industry developments only add to your duties instead of lightening the load.
The rapidly advancing technology in cleanrooms paired with complex manual procedures makes real efficiency harder and harder to achieve. It also leads to skipped tasks, missing signatures, and lost documents. A seemingly minor mistake can result in substantial time and budget going to waste.
As the complexity of cleanroom cleaning technology grows and operations scale up, this error-prone way of working becomes increasingly unsustainable.
Going digital will help your organization alleviate these issues.
At this point, you might be thinking that we haven’t told you anything you didn’t already know.
You might have questions like: what does “going digital” even mean? How does digitalizing prevent these same problems from popping up? What tangible benefits can I expect?
Perhaps you’re already on the digital CRC management bandwagon and have trouble convincing those around you.
If this sounds like you, read on!
Digitalization to the rescue
To digitalize means to start using software or other digital tools to capture data that used to be analog or paper-based, and streamline and optimize the use of that data. In this context, digitalization means improving cleanroom cleaning operations by automating their management. Similar changes have already been introduced in many other settings – let’s illustrate this with a simple example: road navigation.
For nearly a century, paper maps were the gold standard. Using them meant stopping our car on the side of the road, searching for our location on the map, and remembering the route.
After the turn of the century, traveling became a lot less tedious. Digitalization had arrived, and GPS took over as the go-to road navigation solution.
Nowadays, almost nobody uses paper maps anymore because GPS does things paper maps never could. It tells us where we are in real-time and shows us what to do next instantly.
It also analyzes and reports many aspects of our driving in real time. For example, we know where and how far away our destination is, as well as our estimated time of arrival. Access to online information even accurately judges the traffic.
Today, this well-validated system is the gold standard we rely on.
We chose this example because it translates directly to CRC management. CRC digitalization means that the cleanroom cleaning operators use software with optimized protocols and schedules and interactive instructions instead of physical paper copies.
Like GPS, the software instantly shows the cleaning schedule, evaluates progress, and presents the next steps. You don’t have to stop, search for the instructions, and figure out what has and hasn’t been done yet.
And that's just the tip of the digital CRC management feature iceberg.
When implemented correctly, a digital CRC management solution serves as a single centralized hub where you manage tasks and schedules, prepare and schedule masterplans, collect and analyze data, and supervise compliance with regulations – while being as intuitive as the paper alternative. Solutions can even include real-time monitoring, automated reporting, and cloud-based data hosting (bypassing the hassle of on-premises servers).
So how does doing these things in a digital environment translate into tangible benefits for you and your CRC operations?
Well, stick around and discover how digitalizing your CRC management helps you mitigate risk, streamline compliance, and optimize your workflow.
Benefits of digital cleanroom cleaning management
Mitigate risk
If you’re only familiar with manual CRC management, it might be hard to notice just how risky a paper-based workflow is. Misplacing documents such as cleaning records, or forgetting to sign them off, are just two of numerous issues that can arise in the daily life of a CRC operator.
On the other hand, digital CRC management removes these issues from the equation and ensures processes are followed correctly.
With digital workflows, each step is traceable and can be monitored in real-time. The instructions for the operators are interactive, ensuring they perform all their tasks in the correct way and order. Not ‘ticking off’ a task will not only stop access to further instructions, but also trigger a warning and require the operator to log a comment, therefore safeguarding error-free operations.
Additionally, digital record keeping and reporting guarantees they are safely stored in a virtual space. They remain easily accessible online, so forgetting them in the car or at home is a nuisance of the past. But risks are not the only thing that is reduced with digitalization. It also means that you’ll have much less work to do to comply with regulations.
Streamline compliance
Managing a cleanroom involves regular audits that benchmark your compliance with regulations. Although they’re necessary to enforce quality standards, they can feel burdensome. Especially if you’re victim of the widespread misconception that paper-based management is the most reliable.
The truth is that digitalization offers functions that are well beyond the bounds of manual workflows and brings your cleanroom closer to audit-ready. At all times.
A digital solution makes standardizing operations easy by ensuring everyone accesses a clear set of procedures and protocols. This, along with built-in data collection, significantly lowers the risk of inconsistencies in the cleaning process and facilitates compliance with GMP and ISO norms. The CRC data records are also useful during audits, as they can serve as evidence of adherence to regulatory requirements. An added bonus: digital records are much easier to organize, catalog, search through, and filter, which fast-tracks the audit preparation process.
Finally, any deviation from the cleaning plan can be instantly reviewed by management – remotely, and without delays.
With risk mitigation and compliance streamlining out of the way, it’s time to talk about the exciting stuff: improving cleanroom efficiency by optimizing your workflow.
Optimize your workflow
Operating even just a single cleanroom costs thousands of euros a day, so operating them efficiently is paramount. That's why one of the most praised features of digital CRC solutions is the ability to optimize your workflow easily.
What does this mean in practice?
With the MyCellHub CRC management platform, you can get ahead of the curve and secure your competitive advantage. Our cloud-based system provides access to all data in real-time. This gives you complete control of your process as it’s performed, and lets you manage and schedule your masterplans easily.
The platform is also a synchronized system, meaning the system synchronizes between the platform users: cleanroom managers, cleaners, operators, owners, and others. The result: easy communication, reporting, and the ability to adjust your workflow together with all stakeholders.
Long-term data recording unlocks new possibilities as well. With smart data collection, you gain additional insights into your workflow, such as identification of trends and bottlenecks. Moreover, you can perform data analysis easily using fully automated reporting.
On paper, digital CRC management certainly makes a convincing case.
But we can imagine you thinking: how does it fare out in the field?
The short answer: remarkably well!
The long answer: we suggest reading the real-life use case of TRU, a leading Belgian cleanroom cleaning company, below.
CRC digitalization in practice – use case
Meet TRU
TRU is a Belgian cleanroom cleaning enterprise founded in 2019 and is known in the industry for its remarkable expertise. Vanessa Morini, TRU's co-founder and CEO, boasts years of experience in the sector. During her time in the pharmaceutical industry, Vanessa experienced firsthand how inefficient and error-prone manual documentation review is. As such, digitalizing TRU’s workflow was a high priority for her.
“I started looking for a company that could help us implement a digital workflow,” says Vanessa. “But I knew I needed someone that would do it in compliance with the GMP regulations. From the start, system validation was crucial for us. Otherwise, we can’t serve our customers who undergo regular audits.”
With these requirements in mind, TRU started the collaboration with MyCellHub.
Digitalizing TRU’s operations with MyCellHub
MyCellHub’s solution is a comprehensive platform that allows the user to fully automate cleanroom cleaning paperwork, starting from creating masterplans and scheduling tasks to automatic GMP reporting and analysis. The platform is intuitive and fully operational from the start, while its highly customizable settings make it a flexible tool.
“It’s an off-the-shelf product that a client can also tweak according to their needs,” says Antoine Jacquot, MyCellHub’s Sales Manager. “These traits make it easy to integrate the platform into client’s processes, without overwhelming them with too much novelty.”
At TRU, MyCellHub’s service is adapted to TRU’s client's specific needs. First off, the continuous monitoring of GMP compliance is made possible through the access to all digitally stored documentation. Additionally, scheduling functionality was implemented to adapt the plan to the client's requirements.
Another crucial feature of MyCellHub’s platform is that it also provides TRU’s cleaners with interactive instructions, making the workflow more dynamic and productive. “This proves beneficial for the technical team as they have less paperwork and interacting with protocols on a screen is more pleasant. Not having to deal with tedious paperwork has done wonders for employees’ morale,” observes Antoine.
Efficiency improvements and cost reductions are two key reasons why clients choose to go digital with their CRC management. The resulting profit increases are more than worth it. Don’t believe us? Then I suggest you keep on reading!
Cleaning smarter, not harder – the real-world benefits
One of MyCellHub’s clients decided to calculate their savings after switching to the digital management system. They discovered that a single site operated by a 15-cleaner team reduced time spent on documentation by 43%, in just a year. They saved over €41,000 and more than 2,080 working hours by replacing pen and paper with MyCellHub’s software. In total, 1,087 sheets of paper were saved thanks to the digital documentation system.
TRU still uses manual workflows with some clients. “They are not yet convinced because paper documentation means you have a hard copy. It’s tangible, you can hold it in your hands and feel like you’re in control,” admits Vanessa. “They don’t realize that the level of reliability and efficiency is much higher in the digital setting.”
Working simultaneously in two different setups, digital and manual, provides TRU with the unique opportunity to compare them in a real-life setting. The advantages of digitalization are clear to Vanessa and the team. Not only does it increase efficiency in cleaning, but it also facilitates simple and fast reporting and enables process optimization. These improvements give TRU a competitive edge and allow them to provide cost-effective services without compromising on their exceptional quality.
Conclusion
The benefits of switching to digital CRC operations are substantial. It can significantly reduce the risk of errors, streamline regulatory compliance, and help you optimize your CRC workflows – saving a lot of time and money in the process.
Despite this, hesitance across the CRC industry is still high. Digitalization may still be regarded as complex by some. After all, it does require buy-in from the team, learning new procedures, and trusting a new management system.
So, what should you keep in mind to smooth a digital transition?
To ensure the integrity and faultlessness of your new digital CRC management, always choose an expert-made solution validated by successful implementation in other companies. Following this simple rule will guarantee that your system will be trustworthy and will boost your efficiency.
People were hesitant to switch from maps to GPS as well. Do you see anyone navigating with maps now? Let’s digitalize your cleanroom cleaning process with MyCellHub!
Still hesitant to go digital ?
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