Automated loading system for lyophilizer: an answer to the stricter GMP
Small additions with an inversely proportional impact for pharma companies. Our director Joris Ceyssens zooms in on some of the new guidelines in the Good Manufacturing Practices (GMP). He explains why this will especially accelerate the automation of loading lyophilizers. And what that automation can look like in practice with an automated loading system.
GMP is a guideline issued by the World Health Organization (WHO). This standard describes the quality requirements that the production and testing of medical products must meet to guarantee quality.
“Both for us as machine builder and pharmaceutical companies, the GMP dictates what guidelines we must follow,” Joris begins. “The GMP stipulates what good practices are. From that you can then deduce how not to tackle certain questions.”
Audit
In turn, several competent organisations use this standard to conduct their audits.
In that regard, there are three additions that deserve the attention of pharma companies.
How should we interpret these additions?
“The first passage stipulates that you must minimize the risk of product contamination. And that different technologies can help achieve that goal.”
The second passage articulates that a bit more sharply, specifically for high-risk operations. Of which the GMP then gives some examples. “The key message: you should avoid direct contact between operator and product as much as possible. Or put another way: direct interventions are considered bad practice. Exclude them.”
The next logical question then is: what does good practice look like?
“In the third and final passage, the GMP leaves little room for interpretation. Robotics and automation can be a solution to exclude human critical interventions.”
Lyophilizer loading
What conclusions should we draw from this? Which specific processes are priorities?
“In practice, I notice that pharma companies mostly focus their attention on one particular operation: loading their lyophilizer.”
“That is usually a process that still involves a lot of manual handling. And manual handling is considered bad practice. So during an audit, you will have to prove that you have done everything possible to prevent contamination. Automation is one of the possible answers.”
At the heart
Automating your loading processes: easier said than done?
“There are several challenges. One: lyophilizers are huge. Two: they are expensive. Three: they are really at the heart of all processes. Everything is literally built around that lyophilizer.”
“That makes it almost impossible to replace this machine. And even if you could, the question is whether you want to. If that lyophilizer is still doing what it needs to do, replacing it is not a worthwhile investment. That business case just doesn’t add up.”
“Consequently, these new requirements ask for interventions in the existing production processes. Think of automatic or semi-automatic loading and unloading systems, combined with barrier technologies.”
Automated loading system
“The solution lies in an additional module: an automated loading system. A module tailored to your loading processes. Installed on the outside of your current lyophilizer. We have successfully designed and integrated such a solution several times now.”
“The basic principle is a magnetic coupling principle driven by a linear carriage,” Joris clarifies. “The actual loading system differs from lyophilizer to lyophilizer – precisely because the initial situation is different each time.”
The benefits, however, are always the same:
- Repeatability: consistent operation reduces product variability.
- Precision: processing without much contact minimizes product scratches and defects. Which maintains product integrity.
- Speed: higher processing speeds are possible.
- Safety: human intervention is no longer necessary and the risk of contamination is reduced.
- Flexibility: existing processes can be automated, seamless integration into current production environment.
- Cleanability: easy to clean and easy to maintain.
Customized loading system
“For one of our customers, we built in the entire automation under the stainless steel bottom of the isolator. That way, we kept the set-up within the isolator limited to a magnetic clutch and guide plates. Thus, we minimized manual operations for this pharmaceutical company. On top of that, the isolator is also easy to clean.”
“Our added value as a prototype builder is precisely that we can start from any initial situation. For every lyophilizer, for every product and for every process – no matter how specific – we can develop and integrate a customized automated loading system,” Joris concludes.
The solution for your lyophilizer?
Curious about the possibilities of such an automated loading system tailored to your lyophilizer? So that you can face your next audit with confidence? We are at your service.
Download the complete guidelines for Good Manufacturing Practices.