The Benefits of Isolator Technology for Aseptic Fill-Finish Manufacturing
Introduction to Isolator Technology
An isolator is an airtight barrier around a sterile manufacturing line that creates a precisely controlled environment that operators can only access through sealed glove ports. Inside the barrier, the manufacturer can control temperature, pressure, airflow, and humidity while eliminating direct human contact- all to ensure the highest level of sterility. Leading industry guidelines such as Annex 1 strongly recommend the use of pharmaceutical isolators as part of a complete Contamination Control Strategy (CCS) for aseptic fill-finish manufacturing.
Key benefits of using isolator technology include:
- Maintaining a high sterility assurance level (SAL)
- Protecting operators from hazardous substances
- The ability to integrate automated systems and join machines together, such as a vial filler and lyophilizers, within a single barrier system for an efficient manufacturing flow and enhanced sterility
- Automatic decontamination cycles, especially useful when producing large batches
Pharmaceutical Isolators vs. RABS
RABS (Restricted Access Barrier Systems) allow for some human operator intervention, while pharmaceutical isolators completely separate operators from the line. Typically, manufacturers can switch between kinds of products faster with RABS than full isolator technology because RABS are quicker to set up and move. To ensure best sterility practices while using RABS, they must be located inside at least an ISO Class 5 to ISO Class 7 area depending on the product.
While operators must receive training to use both isolator technology and RABS, training people to work with RABS is more intense because the system requires more operator interventions to use comparatively. Isolator operators can usually wear grade D cleanroom clothing, which is more comfortable to wear than the Grade B required with RABS.
Fill-Finish Drug Product Types Requiring Isolator Technology
Products that require isolator technology include:
- Biologics
- Cell and gene therapies
- Products with hazardous materials, to protect the operators
- Pathogens with high biosafety levels
Ensuring Isolator Success
To qualify an isolator system, the technical team performs a three-step qualification process. The installation phase confirms that the isolator is built correctly, the operational phase checks that it functions correctly, and the performance qualification tests the system under real-world conditions for aseptic fill-finish manufacturing.
Above all, trained operators are key to unlocking the full potential of pharmaceutical isolators. During training, operators learn about the design, position, and components of the system and how to apply aseptic techniques while using the glove ports.
Other systems and procedures must also be in place to ensure the isolator is working to its full potential. A facility needs substantial power and utilities in place to handle high volume batches traveling through the pharmaceutical isolator, along with a large, established WFI (Water for injection) system. Technical experts must have a process for checking for leaks in the barrier system and provide ongoing monitoring to verify that the environment remains sterile.
Our Investment in Isolator Technology
As part of our capital expansion, we’ve added two brand new isolator systems to our Spokane site. Our isolator on Line 3 has been fully qualified and is currently being used for commercial production, while our second isolator on Line 4 will be ready by our grand opening in early 2026. Our SKAN isolators are fully integrated with our groninger integra bulk sterile fill-finish machines and IMA lyophilizers for high-speed, aseptic fill-finish production.
With our decades of experience with sterile fill-finish solutions, we combine our knowledge and advanced technology to deliver high quality products as your manufacturing partner. Contact us and learn more about how we can collaborate on a tailored, personalized solution that fits the needs and goals of your project.
