As more and more medical devices are developed, there is an ever increasing need to develop BIs that can be used to monitor the processes used to sterilize these intricate devices. If traditional BIs won’t work and these custom BIs aren’t created, the only alternative is to directly inoculate the devices and that presents a whole new set of challenges.
An existing customer approached us with a situation where they were trying to validate the sterilization of a very long, narrow lumen. No standard BI would fit in the narrow opening and the customer was not interested in direct inoculation. They were particularly interested in verifying that sterilization conditions were achieved throughout the entirety of the long lumen. In order to provide the customer with this information, a 48-inch polyester suture was inoculated at various specific locations along the length of the material. Once inserted into the lumen the inoculated area coincided with the most difficult area of the lumen to sterilize.
After the sterilization cycle, the BI was removed and placed in a bottle of recovery media and monitored for growth. Sounds a lot easier than direct inoculation, doesn’t it? As we move forward and more intricate components/devices and sterilization process are created, it will become increasingly important to ensure we are properly monitoring the sterilization of those items. In some instances, the best way to do this will be with a custom biological indicator.
For more information on what Mesa Labs has to offer please click here.
Mesa expert’s co-author article on minimum incubation times for Biological Indicators
Garrett Krushefski and Kurt McCauley of Mesa Biological Indicator division have co-authored an article featured on Pharmtech.com. This article focuses on proposed minimum incubation time for biological indicator grow out times.
You can read the article in its entirety at the link below: http://bit.ly/1hni3rQ
Standard Biological Indicators (BI’s) are perfectly suited for most sterilization validation/monitoring situations, but there are instances where additional information about the cycle or the products resistance is useful. Due to a desire to place a BI in more difficult to reach areas within a product or because of extreme cycle parameters, Mesa has developed a complete line of Industrial Use BI’s that can accommodate several unique situations and cycles. This video details these specialty items and highlights their initial intended use.
Contact us today at BIsales@mesalabs.com to discuss your specific cycle to see if a specialized solution is appropriate for your needs.
Extended sterilizations cycles are becoming more and more common as manufacturers are incorporating complex materials and designs into medical devices. It can be very difficult for the sterilant to penetrate a narrow path or throughout a very dense or heavy load with traditional sterilization cycle times so increased sterilization cycles are something manufacturers are dictating more and more. Certainly longer cycles are intended to allow for fewer positive biological indicators, but are all biological indicators designed to provide accurate results in extended cycles?
For self-contained biological indicators, as the spores are exposed to an extended insult, the recovery/growth media is exposed as well. In many instances, this added exposure will start to caramelize pH indicator color within the growth media and the media itself will appear altered post-sterilization. A logical question to ask is “Can this media still sustain growth for a low number of injured spores?”
Mesa has performed a study on its ProSpore Ampoule self-contained biological indicator to address this topic specifically by exposing ampoules to a typical 20 minute cycle in addition to an extended 120 minute cycle, looking at the color change of the media post-sterilization in addition to the media’s effectiveness throughout the incubation process. The results of this study can be seen here.
In the world of Biological Indicators (BIs), many technical terms are used to describe the attributes of a specific production lots of indicators. Many of these terms are attributes included on the Certificate of Analysis for an individual BI product detailing the subtle differences that cause any specific lot to perform or behave as it does.
In the latest edition of Spore News, Garrett Krushefski explains some common terms related to biological indicators including D-value, Z-value, Fbio and more. Driven by customer feedback, this issue gives an in-depth look at several industry terms and the impact each one has on BI performance and how this information can be used to evaluate the specific characteristics of a particular BI lot.
Click here (http://us1.campaign-archive1.com/?u=dbc324d0e9836c1d17ab7d4aa&id=be503f03da&e=4b1215ae34) to read the complete Spore News article and don’t forget to sign up to receive Spore News in your Inbox!
For more information on biological indicators click here! http://www.mesalabs.com/biological-indicators/
In the Resistance Performance Tests section of USP 31, it states to culture biological indicators (BI) ‘within a noted time, not more than four hours’ after the sterilization process. In reality however, this is not always possible due to several different situations. For instance, many ethylene oxide cycles can take several hours to aerate post-sterilization preventing access to the load and the BIs contained within. Clinical monitoring services will also have difficulty meeting this 4-hour window due to the fact that these services are mailed exposed indicators from a clinical setting for culturing and the BI may be in transit for a number of days before they are able to be transferred into culture media and incubated.
Biological Indicators have proven themselves to be extremely valuable tools for verifying sterilization conditions within sterilization cycles over the several decades in which they have been utilized. As many would say, “The bugs don’t lie”. And, what better way to test for the destruction of microorganisms that to test the cycle with highly resistant biological indicator containing a quantified amount of bacterial spores?
Biological Indicators will continue to be the gold standard for sterilization verification, but there are more tools available to provide additional information about cycle parameters and specifics. Used in conjunction with biological indicators, chemical indicators provide an inexpensive supplemental benefit of being able to monitor many more locations within the cycle than may be possible with biological indicators alone.
Chemical Indicators come in a variety of options and all are designed to target the specific information that is sought after. From the Bowie-Dick test, (which tests a sterilizer’s ability to remove all of the air from the chamber) to Class 4, 5 and 6 Integrators and Emulators, chemical indicators can provide valuable information to the user and about the items being sterilized.
To learn more about Mesa’s Chemical Indicator offerings, please see our CI page here or contact us for samples and pricing.
A customer recently contacted us detailing how positive biological indicators (BIs) were popping up in their Vapor Hydrogen Peroxide (VHP) process. The customer explained that they had no trouble with a square shaped room but when the configuration of the room changed (to an L-shaped room for example), they would experience unexpected positives. The positive BIs always seemed to occur in the same general area.
So what is wrong with the BIs?
Since the positive discs are showing up in the same general area of the room, it is most likely that the user may have a problem with the delivery of the lethal gas to some areas of the room. In this instance, the BI is doing exactly what it was designed to do, identifying the area of the chamber/room that is not receiving an appropriate dose of sterilant.
Mesa’s Technical Support team explained that the BIs are indicating that the circulation is not sufficient in this area in order to achieve the sterilization levels that the user is trying to accomplish. As is often the case for VHP sterilization, fans are needed in order to help the sterilant circulate throughout the more difficult areas to reach.
The BI Support team also pointed to the following documents from Mesa that have helped this user in redefining their procedures:
addresses Parameters Effecting Vapor Hydrogen Peroxide BI Performance
addresses Proper BI Placement During VHP BI Performance, and
addresses Using Replicate BI’s
For more information on VHP sterilization and BIs, please send any inquiries to email@example.com.
Mesa is preparing to exhibit at the Interphex expo, a top pharmaceutical and biopharmaceutical trade show held each year. Many key people in this industry attend to see new products, meet new customers, and to network with fellow community members. There are over 1000 product lines that represent every product category at the show and 650+ supplies that come to feature their latest innovations.
This year it will be held again at the Javits Center in New York, New York. The show exhibits will be open Tuesday April 23, 2013 through Thursday April 25, 2013. There are also 52 conference sessions that can be attended in 3 days.
While there, Mesa will be highlighting 2 new products: Intenna and Thermowell. DataTrace® InTenna is attached to the vessel by using a standard clamp fitting and sealed inside the vessel through any common service outlet. This enhanced capability means that retort cook cycles will always be able to hit their mark using the real-time feedback of the wireless data. DataTrace® Thermowell Data Logger allows for the addition/removal of the logger without breaking the seal! This logger is ideal for monitoring temperatures in a sealed container such as a can or bottle or for an SIP or CIP system at the typical monitor points where the Thermowell can be welded directly into piping allowing the logger to be easily removed and replaced when desired without shutting down the process. (more…)
Last week, we announced the launch of our new Smart-Well® 1710 incubator as part of our Smart-Read EZTest® Biological Monitoring System. In this video, we show you how to configure and use the new Smart-Well Incubator using the easy-to-use touch screen interface. (more…)