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

http://www.mesalabs.com/wp-content/uploads/2012/09/Spore-News-Vol-9-No3.pdf

 

addresses Proper BI Placement During VHP BI Performance, and

http://www.mesalabs.com/wp-content/uploads/2012/10/Spore-News-Vol-9-No5.pdf

 

addresses Using Replicate BI’s

http://www.mesalabs.com/wp-content/uploads/2012/09/Spore-News-Vol-9-No4.pdf

 

For more information on VHP sterilization and BIs, please send any inquiries to bi-support@mesalabs.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…)

When selecting a biological indicator (BI), there are a lot of things to consider, but the three most important considerations are below:

1. What Type of Sterilization Is It?

Sterilization processes vary from chemicals to extreme temperatures to plasma infused chambers. These processes are all detrimental to the survival of biological materials but the selection of what particular biological indicator to use for each individual process is of extreme importance.

Biological indicators are made up of bacterial spores presented on or within some form of carrier which can vary depending on the specific application. The spores themselves have been selected for a particular process due to their inherent resistance. Geobacillus stearothermophilus is the ideal species to select for Steam and H202, Bacillus atrophaeus is appropriate for monitoring Ethylene Oxide and Dry Heat sterilization and Bacillus pumilus spores have shown specific resistance to gamma irradiation sterilization processes.

2. What Product Is Being Sterilized?

A cold, 2 Liter flask of water would take much longer to reach sterilization temperatures than a 100 ml flask of water in a steam sterilizer. Similarly, the products that are introduced to the sterilization cycle can have a dramatic effect on the sterilizer’s ability to effectively deliver lethal insult. Is the product a solid or a liquid? If solid, it is porous? What is the position within the pack/product that will be the most difficult spot to achieve sterilization conditions? All of this information is useful when discussing proper BI placement and selection. (more…)

In this video, we show you how to position a biological indicator in the center of a length of tubing for the most accurate validation of a sterilization process. This is done by using our ProLine PCD biological indicator.

In this video, we discuss why DriAmp Biological Indicators are a better choice than paper strip style indicators for dry heat sterilization processes.

Why use a liquid submersible biological indicator to test liquid loads vs. an EZTest (SCBI) or spore strip? In steam sterilization the steam typically comes into direct contact with solid items. When sterilizing liquids however this is not the same type of process. The steam from the autoclave will make contact the container but, unlike solid goods, the steam never directly contacts the item that needs to be sterile; i.e. the liquid inside.

Also one very important concept to consider is the “lag time to temperature.” The chamber reaches the exposure temperature quickly but the liquid will take some additional time. This can be unique depending on the volume that is in the vial and on the cycle parameters themselves. (more…)

There are a wide variety of off-the-shelf, readily available Biological Indicators (BIs) offered across the industry that can provide the information that a user is looking for or provide the challenge required for a specific cycle. There are some circumstances however that will require a specialized and/or customized approach. Perhaps you would like to verify that you have achieved sterilization conditions in a tiny nook in your product packaging where a Spore Strip or SCBI (Self-Contained Biological Indicator) simply won’t fit and the Industrial Use BIs offered simply do not meet your needs. What are your options?

When validating a sterilization process, there may be any number of instances where a customized indicator may be required where a commonly available BI simply won’t due. In addition to offering a number of standard BIs, Mesa also offers a line of Industrial Use BIs that is meant to offer options and solutions in these exact instances. There still may be situations where what is commonly available simply won’t do and this is where a customized BI can come into play. (more…)

Purchasers of BIs have established methods to ensure that the BIs they purchased are acceptable from a quality standpoint. These methods are not consistent among BI users. Many users perform audits of the manufacturer and/or test the BIs in-house. Others will send their BIs to an outside laboratory to be tested (i.e. a third party test).

Performing quality audits are costly, but not as costly as performing extensive testing on each lot of BIs. Additionally, many lots of BIs will be rejected by second and third party testing, not because of a BI defect, but because of differences in test equipment and techniques.

See Part 1 and Part 2 of our Spore News articles on this topic written by Kurt McCauley to see a detailed study on this topic.

 

Forbes ranks companies in the United States every year based on their growth rate and level of success. The 100 Best Small Companies in America on this list show strong sales and earnings growth across industries. Candidates must have been publicly traded for at least a year, generate annual revenue between $5 million and $1 billion and boast a stock price no lower than $5 a share. (more…)