Flexible solutions for pharmaceutical processing

FAQs – SKAN Isolator

How big is the isolator? Will it fit into my room? 

The typical height, width and depth of a VarioSys® isolator module is 2888 mm tall x 1900 mm wide x 1130 mm deep (114” H x 75” W x 45” D).  In addition, there is a control panel which may be attached or stand-alone (same height, 520mm W or 20.5”W) and a modular SARA (Safe and Rapid Airlock) which is 696mm wide (27.5” W).  Each of these modules can also be broken down into smaller pieces for initial entry into a room for assembly or for access via service elevators.  Consult your SKAN technical adviser for recommended layouts and service access allowances depending upon your system configuration.

Is there any HVAC skid in addition to the isolator shell?
Typically, all of the necessary HVAC, including the hydrogen peroxide decon system is built into and fully integrated within the isolator shell and footprint.  For some special applications with extreme temperature, RH or inert gas requirements, supplemental HVAC components or skids may be added to the system and may be located in an adjacent space or directly above the target isolators. 

Do I need a separate H2O2 generator to decontaminate my isolator? 

No, the SKAN hydrogen peroxide biodecontamination system is fully integrated with the isolator system.  There is no separate control or equipment required and SKAN provides a full package of safety, testing and qualification of the isolator and biodecontamination system. 

Does the isolator have unidirectional airflow? 

Yes, the SKAN isolator utilizes unidirectional airflow to create a fully compliant Grade A / ISO 5 environment.  The design basis provides 0.45m/s (90 ft/min) airflow to sweep over the process to remove and minimize particulate generation.  Extensive research and CFD (computational fluid dynamics with computer modeling) studies have been performed for the isolator and process equipment designs, as well as live, in-situ video recorded air flow studies to demonstrate excellent unidirectional flow.  

Is the patented NANOX® catalyst available for use with the VarioSys® Isolator?   

SKAN’s unique and patented catalyst is available with VarioSys® and provides a number of great advantages.  Primarily, this catalyst allows the isolator to be installed in the room and exhausted without any outside exhaust vent to the roof.  This saves tens of thousands of dollars in expensive installation costs and facility modifications.  Also, during the aeration portion of the decon process, when a typical isolator consumes hundreds to thousands of cubic feet or cubic meters per minute of room air vented to the outside, the SKAN isolator safely returns that pre-conditioned air back to the room, thereby maintaining the appropriate pressure balance within the cleanroom (no wide-range dynamic balancing required).  Finally, this saves not only facility installation and control costs, but it saves utility costs and is a “green” and safe solution to help the environment.

How long is the biodecontamination cycle for the isolator? What about the SARA (Safe and Rapid) Airlock?
The typical cycle in the SARA Airlock (which is an optional system that can be used to introduce materials or components into main isolator) is 20-30 minutes for a full 10E6 BI kill level and aeration down to <1 ppm.  The main isolator system decon cycle can range from 2-4 hours for a typical cycle with aeration to <1ppm and longer for lower levels of aeration.  With the new SKANFOG® decon process option available in 2018 coupled with the NANOX® catalyst, <60 minutes for a full 10E6 BI kill level and aeration down to <1 ppm is expected, depending upon the process equipment and load conditions.

Can the VarioSys® Isolator be used for other aseptic processes or must you use it only with a filler or lyo?
Yes, the SKAN VarioSys® isolators are very flexible and can be used for most any aseptic processing steps from cell therapy and compounding to specialized filtration, bioprocessing or aseptic drug-device assembly.  Many manual or automated processes can be integrated into the L-flange with our partners’ process equipment and be customized for most any aseptic process. 

Can a process tank and/or filtration skid be integrated with the L-flange system?

Yes, product tanks and process piping can be built-into the L-flange system with permanent / welded connections as well as other novel integration methods with seals (gaskets and inflatable) that allow you to remove the tank or other vessel for cleaning and autoclaving out of place and/or CIP/SIP (Clean in Place/Steam in Place) along with the process piping.

Can I use a VarioSys® isolator for potent compounds, ADCs, cell therapy or other special manufacturing substances or situations?

Yes, these isolators are VERY flexible and can be adapted for many manufacturing applications.  L-flanges have been adapted with incubators and other chambers for cell culture applications and the isolators can be used under positive or negative pressure with additional return air filter systems for “safe-change” HEPA filtration for containment of potent compounds, even of Band 4-5 materials (low microgram or nanogram level containment).  Consult your SKAN containment expert for example applications and a process risk assessment.

Is Wash in Place (WIP) possible?

Yes, machines and the isolator are designed for a manual WIP with spray wands.  Automatic WIP is under development.  The inflatable seal for the L-flange is specially designed to be “washdown compatible” so there is no crevice for soil, liquid or microbial accumulation.

 Is gas flushing possible?

• KSF5105 filling and closing machine: gas flushing before and after filling

• SFM5105 filling and closing machine: gas flushing during filling and during closing

• A full nitrogen (or other neutral gas) environment is also possible with a low oxygen processing environment for preservation of fragile or solvent-based materials in filling or compounding applications.  Existing applications have gone as low as 2-5% oxygen (typical ambient is 21% O2) but lower may be possible depending upon the application and gas consumption requirements.

Is environmental monitoring included with my VarioSys® isolator? 

Depending upon the application and process, SKAN or our partner process equipment suppliers provide the integrated particle counters, active viable air sampling systems and/or passive viable air sampling equipment.  In any case, SKAN can provide a unique valving system to draw hydrogen peroxide decontamination agent through the lines of the isokinetic probes and air sampling units to ensure that no deadlegs remain unexposed to the H2O2 decon process. 

Who will validate my VarioSys® isolator? 

SKAN works hand-in-hand with our equipment partners to provide a comprehensive validation package utilizing best practices from each process equipment supplier.  For the isolator, SKAN provides all GAMP (Good Automation Manufacturing Practices) documentation in addition to a thorough IQ/OQ (Installation and Operational Qualification) and CD/MBQ (Cycle Development / Microbiological Qualification) process with options for basic and extensive qualification packages.  SKAN’s cycle development and microbiological qualification methodology is cited as a reference in the 2004 FDA Aseptic Guidance document.

Is it possible to use scales on a mobile module and within the isolator with unidirectional airflow? 

Yes, anti-vibration compensation (AVC) technology is used to reduce vibration that might affect the performance of weigh scales.