The Big Little Things, Part II: Port Disinfection Subsystem

Posted on September 23, 2014

By Walter Eliuk, P.Eng.

RIVA is a fully automated IV compounding system that produces IV bag and syringe medications in a Hospital pharmacy.  The Port Disinfection Subsystem (PDS) is a powerful feature unique to RIVA.  This feature helps to assure reliable aseptic processing of compounded products.

A state-of-the-art UV light source is used to disinfect critical needle entry sites on vials and bags inside the RIVA cleanroom compounding area before they are used.  The UV source is specifically tuned to perform disinfection.

The RIVA UV disinfection process has been shown to be at least as effective as careful, best-practice manual IPA (alcohol) wiping technique for the reduction of bacteria and spores.

A drug vial’s journey to PDS…

Load the Vial into RIVA – The vial is loaded into RIVA from within a protective clean-room vestibule. During loading, the user follows best-practice techniques for aseptic handling of consumables, and swabs all vial stoppers with a wipe and IPA.

Vials and bag critical sites wiped with IPA

Vials and bag critical sites wiped with IPA

Inspection of consumables prior to loading into RIVA

Vials and other consumables are being inspected prior to loading; their expiration information can be entered to the system

After loading, the vial resides in RIVA’s inventory carousel area until it is needed.

ID Check the Vial – When the vial drug source is needed, the carousel presents it to the compounding area, and the robot grabs it and conveys it to the vial ID station.  The vial is rotated at the station, audit images are captured and stored, and the vial ID is confirmed with barcode or pattern match.  If the vial ID does not match what is expected, the vial is rejected and given back to the user via the Reject Rack.

Vial at the ID Check Station

Vial at the ID Check Station

Perform a Vial Height Check, Just to be Sure – During vial ID, the Port Disinfection System prepares to receive the vial by checking for the correct state and status of PDS sensors.  The robot picks the vial from the ID station, and a “height check” is performed.  The height check ensures the vial top is positioned where it should be and that the robot grab is good.

Robot Holding Vial at the Height Check Station

Robot Holding Vial at the Height Check Station

Vial Ready to be engaged into the Port Disinfection System

Vial Ready to be engaged into the Port Disinfection System

 

Engage the Vial into the PDS – The robot then conveys the vial to the PDS and engages it.  The system checks that the vial is properly engaged and that a light-tight seal has been achieved.  It then arms the UV firing circuit if safety conditions are met (cell doors are all closed).

Vial Engaged into the Port Disinfection System

Vial engaged into the Port Disinfection System

Fire the UV PDS; Just a Second Will Do – The UV source is turned on, and an indicator light on the PDS shows that it is in operation.  RIVA performs continuous high-speed monitoring during the exposure to ensure that the UV light is applied to the right location, and that the full exposure is applied.  The exposure lasts about a second.  After PDS exposure is complete, the vial is ready for immediate use, or can be parked on a shelf for later use.

RIVA Temoporary Storage - Parking

Vials are parked between uses in the temporary storage area called Parking

Can Redo, Works for Bags Too – The PDS is also used to re-disinfect the injection ports of vials in parking after the compounding area has been accessed by the operator for cleaning.  A similar process is used to disinfect the injection ports of IV bags before they are used in RIVA.

User Safety First – There is no exposure risk to the user. The disinfecting UV light is contained, and a safety system will not allow the PDS to turn on if the RIVA doors are open, or if a vial or bag is not properly engaged.

Very Effective – Don’t confuse the RIVA PDS function with simplistic, low intensity UV bulbs sometimes used for spotty, long term exposure disinfection. This method would NOT perform timely disinfection of critical sites before use.  The RIVA UV source is very directed, narrow-band and intense, so that it can achieve the required disinfection in about one second.

Automation Reduces Risk – The use of proper aseptic technique is still essential when handling consumables.  However, the UV PDS is a powerful automated mitigation to the risk of critical site contamination.

Summary:

  • UV light is used to disinfect critical needle entry sites on vials and bags before they are used.
  • The PDS kills bacteria and spores, and is at least as effective as careful, best-practice manual cleaning with IPA.
  • The PDS is a powerful risk mitigation for user handling of sterile consumables.
  • Safety checks ensure no risk of UV exposure for drug or user.

Conclusion:  The UV PDS is a unique and compelling feature of the RIVA fully-automated IV compounding system.

 


Walter Eliuk is a Systems Engineer at Intelligent Hospital Systems, developer and manufacturer of RIVA – a fully automated IV compounding system

 

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