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Although pharmaceutical manufacturers take stringent steps to ensure that their production systems are as safe as possible, a fully gowned operator can still create as many 150,000 particles per minute, meaning that drug manufacturing is never a completely hazard-free process.
Due to the risks involved, it is vital that manufacturers ensure the sterile transfer of active pharmaceutical ingredients (APIs) and formulation ingredients during aseptic processing. A wide range of techniques have been developed to make sure that the manufacturing process is as safe as possible. But which methods are the most popular? And why do they stand out?
Several barrier technologies have been developed over recent years with the aim of providing micro environments that offer high levels of microbiological protection. Primarily, this kind of technique separates the operator from the product to stop contamination.
Isolators are thought to be highly effective physical barriers. They provide an enclosed working environment that allows for manipulation to take place from outside of the enclosure without compromising integrity. Positively pressurised chambers and HEPA filtered air both help to create safe environments where products can be manufactured.
It is paramount that isolators create safe enclosures, so integrated pressure decay tests are usually conducted during start up and ahead of any decontamination, with the leak of the chamber being a key factor in the classification of the device.
Restricted access barriers (RABs)
Similarly, this method places a barrier between the operators and the production environments. It also offers flexibility because operators can still interact with the process outside of the sealed enclosure.
Active RABs are amongst the most widely-used barriers, because they actively pull the air from outside the cleanroom environment, filtering and extracting it so it is completely isolated. However, passive RABs are also popular. They use the HVAC systems found in cleanrooms to filter the air and provide a controlled environment.
There are also several subcategories of RABs, which are commonly used by multiple manufacturers:
Comparing isolators and RABs
RABs are often seen as extremely effective, because they allow for faster start-up times and easy changeovers and bring more operational flexibility and reduce the validation expenditure. However, isolators are beneficial because they allow for higher integrity chambers and a more robust closed solution.
Split butterfly valves (SBVs)
Although both RABs and isolators have their advantages, many companies now incorporate split butterfly valves (SBVs) to safely transfer products from one container to another.
The valves are made up of two key units, the active unit and the passive unit, and each unit holds half of a butterfly disc. The active unit is attached to the stationary process equipment. However, the passive unit is attached to the mobile container. When the two halves come together, they create one disc, sealing any surfaces which may have been exposed. Once the surfaces are fully sealed, a gap is created where hydrogen peroxide gas can be flushed through to allow for decontamination.
This method is highly popular because it achieves a validated 6 log reduction at the point of fill, reduces the need for manual intervention, and reduces the resources associated with cleaning large environments.
Compared to conventional airlock or isolator techniques which often have processing times of around four to six hours, SBVs have a rapid processing time of just 4 to 30 minutes. SBVs are also a lower cost alternative to traditional methods. Finally, SBVs also make it possible to downgrade cleanroom environments because of the integrity of their approach.
All manufacturers are different, as is every product that they process. Therefore, each manufacturer will use different techniques to ensure that their system is as safe and efficient as possible.
On the one hand, isolators are easier to decontaminate and monitor. They also offer a high degree of sterility assurance. On the other hand, RABs provide both increased operational flexibility and quick changeovers, which appeal to many manufacturers.
Whilst many manufacturers incorporate isolators or RABs into their systems, a wide range of manufactures also use SBV technology to compliment these techniques, using a broad combination of methods to ensure the best results.
Whichever methods are thought to be the most suitable, it is vital that a full evaluation of products and processes against the various systems takes place in an early project phase to ensure the right technology is selected.
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