In this world of isolators and Restricted Access Barrier Systems (RABS), Spain-based Telstar is a major player. The containment expert has extensive experience in the design and manufacture of isolators for global pharmaceutical and biotech companies.
Telstar launched a new dual-mode isolator system in March 2024. This new system is capable of operation for either containment or aseptic purposes.
The company’s Product Manager LSE Barrier Systems, John Williams, talks about this new launch and other observations from the cleanroom containment sector.
Williams says that Telstar’s new dual-purpose isolator reflects some of the larger changes in the containment sector in recent years. Specifically, it addresses a need that arose since the pandemic. “Since COVID-19 we have seen an increased demand for more adaptable systems able to cope with potential changes in future demand as well as isolators that can adapt to multiple applications such as our Dual-Purpose Isolator,” Williams says.
Since COVID-19 we have seen an increased demand for more adaptable systems
With the ability to handle various processes in one unit, this new isolator reduces the need for excessive equipment and creates a more efficient use of available space. In addition, the unit being dual mode is a cost-effective solution, reducing the need for multiple isolators in some cases.
Williams explains that the number one challenge that his customers were looking to address with this system is reduced footprint, and therefore reduced costs. “[Operators] get the use and benefits of two systems in one for reduced capital cost, reduced footprint within a grade C/D room and reduced running costs,” he explains.
It’s a funny story
In the containment sector, it is important to know what you are doing.
Williams has seen it all when it comes to incorrect equipment use: “We have seen a number of examples of this that would leave you aghast and in wonderment. Things like weighing in an isolator that’s not running (identified by the lack of any lighting, off for safety reasons); an installation company halving the leg height to make up for a chute spool piece they could not locate (made for a nice kneeling position) and a pharmaceutical company asking an engineering company to partake in the ergo trials when they did not even know the actual operations (it reminded us of the tyre swing project).”
So getting experts involved is never a bad idea!
Isolators vs RABS
A major change in the industry in the last year has been the release of Annex 1, which impacts sterile production. Williams says that in its wake he has seen a marked increase in the demand for isolators over RABS.
When understanding why, it is important to understand the true difference between these technologies. “Aside from passive and active open RABS, which direct all the airflow back to the cleanroom once passed the working zone, isolators and closed RABS are very similar technologies at face value but it is in operation that they differ,” Williams says.
He explains that isolators are designed to separate operator and product for protection purposes of one or the other or both with a controlled airflow and testing to specific leakage rates. On the other hand, closed RABS are a physical barrier only but perform a similar function albeit to a much less stringent degree with no guarantee of leak tightness. So these would be unsuitable for handling potent products or for stand-alone biodecontamination with Hydrogen Peroxide.
Understandably, therefore, isolators and RABS compete for the same space in a cleanroom. Williams thinks the preference for isolators actually comes from the cost savings outside of the device. As the isolator keeps the process more contained, the cleanroom standards outside can often be relaxed.
“It is the relaxed cleanroom standards for isolators coupled with the expense of building and running a grade B cleanroom go some way to explain why [isolators are preferred],” he says. “As such we are seeing fewer requirements where grade B cleanrooms are being built.”
Contamination control
There have been some interesting focuses on contamination control within isolators and RABS in recent years.
Decontamination systems are starting to be built into containment solutions, as well as new forms being used in mass.
“Within our isolators, we have worked with multiple different technologies including vaporised, ionised and nebulised delivery systems,” Williams says.
He explains that he believes all decontamination technologies have their place in specific situations and circumstances and are dependent upon the size and number of isolator chambers involved.
“For example, a gas or vapour phase system is beneficial when distributing from a central generator over a large area or into a system with complex moving multi-part system like filling lines,” Williams explains. “However, it could be considered excessive in a smaller isolator where a single or dual injection nebulisation or ionising system would perform just as well for lower capital and running costs.”
Decontamination systems are starting to be built into containment solutions
Williams then talks specifically about vH2O2. He explains due to the compound’s slightly smaller particle size, it can tend to penetrate some materials, such as Tyvek. “This can cause issues with some clients’ procedures/products,” he says. “Tests to show kill inside the Tyvek bag exist but still leave the client with the predicament about possible product contamination as a result of the ingress.”
Another important factor to consider for contamination control in containment equipment is the concept of “first air”. The basic principle is that after the air has left the HEPA filter/distribution screen, the first element it should contact is the critical process zone.
“This is especially important as it works to reduce the risk to the aseptic process,” Williams explains. “In practice, there will be various obstructions in the airflow path, therefore it is not always possible to maintain the same flow pattern from ceiling to working height, but the layout must be considered, the risks reduced as much as possible and the critical aseptic core left unobstructed.”
He explains that in order to combat any issues, smoke trials should be carried out to demonstrate the path and recorded in the CCS (Contamination Control Strategy).
Annex 1
The new Annex 1 has clarified the minimum cleanroom standards acceptable for each technology. “This is a welcome move,” Williams says.
He explains that although the majority of the new requirements for containment equipment design have already been adopted within the last decade, there are a few aspects that have been refined and are seeing issues since the document’s release.
“To be honest the main difference is the airflow position for monitoring purposes and the requirement to measure this at working height,” Williams says. “Due to first air principles whereby airflow first becomes ‘disturbed’ by fixed obstructions such as robots, stopper bowls etc., measurements at the working height for control purposes is almost impossible to implement and as such measurement at 150mm below the ceiling filter/screen remains the most realistic position for control purposes.”
Trends in pharmaceutical manufacturing
For the pharmaceutical industry, Williams has also seen a definite increase in the demand for even lower containment performance isolators. “This puts pressure on isolator manufacturers as well as manufacturers of transfer valves/ports etc. to ensure the complete solution can meet these lower levels in the future,” he says.
This fits in nicely with another huge trend in pharmaceutical manufacturing; automation. “I can see this leading to the automation of more processes thereby demanding gloveless isolators, however, this will prove an interesting challenge as many of the applications may not be as easily automated thus a gloveless isolator will be interesting in certain situations.”
Already seeing an increase in demand for gloveless isolators, Williams goes on to explain that this will require close cooperation with filling line manufacturers to ensure the process can indeed be operated without manual intervention.
There does appear to be an increased demand for upgrading and retrofitting of isolators
Retrofitting is another trend that Williams is seeing throughout the pharmaceutical sector. The hold-back on this seems to be the risk of “hidden costs” with modifying existing equipment. He says that this is why there is still a lot of interest in newer technology.
There does appear to be an increased demand for upgrading and retrofitting of isolators to existing systems although investment in newer technology still tends to be more attractive due to hidden costs involved in modifying existing equipment.
Williams is also seeing a move from HMI control systems to dedicated to Supervisory Control and Data Acquisition (SCADA) system control for improved data retention and reporting. These SCADA systems are used for controlling, monitoring, and analysing industrial devices and processes.
A helping hand
To make sure operators are able to comply with all that is needed when using this technology, Telstar takes clients through the operations and maintenance of the isolator system during the commissioning phase.
“Classroom training and certification can also be provided on request depending on the clients' specific requirements,” Williams adds.
This is at the end of the process, but during design, a thorough ergonomics trial is also carried out for clients to challenge the design concept by working with a life-size model.
Telstar’s global presence of support services means that local support can be provided for all its products.