The STERRAD VELOCITY™ System comprises of:

• the STERRAD VELOCITY™ Biological Indicator/Process Challenge Device (BI/PCD) 
• the STERRAD VELOCITY™ Reader

It is manufactured specifically for use in STERRAD™ Systems and is the only BI/PCD validated by ASP.

Our BI/PCD is an easy-to-use, self-contained that reads with certainty, providing fast and efficient sterility assurance to help improve instrument turnaround time.

It is the only BI/PCD system that communicates with STERRAD™ sterilizers, thereby enabling the automatic documentation of each cycle and allowing users to quickly and compliantly carry out BI processing, to produce audit-ready records.

• As a BI, it complies with ISO 11138-1
• As a PCD, it assures sterility by providing a challenge greater than or equal to the most challenging location in the most challenging device
• When used in conjunction with the STERRAD VELOCITY™ Reader, it delivers a readout time of 15 or 30 minutes (depending on reader software version; see BI/PCD IFU)

Both STERRAD VELOCITY™ BI/PCD and Reader are intended to be used for:

• Frequent monitoring and periodic testing of STERRAD™ Sterilization Systems and their respective cycles (at each cycle or at defined periodicity according to applicable recommendations and standard operating procedures for hospitals)

• Qualifications of STERRAD™ Systems after installation, sterilizer relocation, major repairs or for periodic requalification according to ISO 14937

  For qualifications, STERRAD VELOCITY™ BI/PCD is used in conjunction with reference loads from the STERRAD VELOCITY™ System Validation Kit, which are defined for each STERRAD™ System and cycle

STERRAD VELOCITY™ Biological Indicator is the suggested product replacement for CYCLESURE™ 24 Biological Indicator (BI).

Features

Rapid BI readout

• Read time of 15-minutes – allows users to know the result before they release the load
• Reduces instrument turnaround time, helping users to meet the demands of OR schedules
• Built-in chemical indicator allows for quick identification of processed versus unprocessed BIs
• Multiple wells in the reader facilitate its use in larger hospitals which use multiple STERRAD™ Systems

All-in-one BI and PCD combined device 

• STERRAD VELOCITY™ is both a Biological Indicator as well as a Process Challenge Device, elevating the sterilization process monitoring standard.
• Biological Indicators and Process Challenge Devices represent different levels of challenge in the sterilization process. They are intended to demonstrate whether the conditions were adequate to achieve sterilization and, in general, do not have the requirement to represent worst-case devices per ISO 11138 and FDA guidance.
• Process Challenge Devices provide a challenge to the sterilization process that is equal to or greater than the worst-case medical device loads routinely processed. 
• STERRAD VELOCITY™ is the only all-in-one BI/PCD that meets AAMI guidelines and other global standards and provides sterility assurance by providing a resistance greater than the worst-case hospital loads.
• The STERRAD VELOCITY™ BI / PCD System is fully validated with STERRAD™ Systems and ensures that only medical devices with assured sterility reach the patient, helping to minimise the risk of Hospital Acquired Infections, HAI.

Reads with Certainty

• Uses advanced optical measurement technology to detect biological activity
• Eliminates subjectivity seen with visual interpretation of results

Streamlines BI Processing and Record-Keeping

• Only releases instruments when they are ready, reducing the risk of releasing instruments prior to BI confirmation
• Automatic record keeping provides consistent and complete BI records, aiding compliance
• Compatible with ASP ACCESS™ Technology, allowing automatic correlation of STERRAD™ System cycle records and BI results
• On-board barcode scanner eliminates the need for manual data entry, minimising the risk of error

User-friendly

• Intuitive touch-screen interface provides step-by-step instructions, reducing user errors
• BI results are displayed clearly and easy-to-read countdown timers are shown for each well
• On-screen, audible alerts update staff with critical information

BI Specifications

• α-MUG: a fluorogenic dye activated upon enzymatic reaction with α-glucosidase (AG)
• α-glucosidase (AG): a natural enzyme, produced by spores

When the ampule is crushed, the surviving microorganisms, containing AG, are exposed to a media containing α-MUG. The resulting enzymatic reaction splits α-MUG into 4-MU, a fluorescent compound, and glucose.

If microorganisms survive post-sterilization, the media will fluoresce, indicating a positive BI. Alternatively, in the case that no microorganisms survive after the sterilization cycle, the media will not fluoresce and the BI can be considered negative.