Raven Labs Frequently Asked Questions
How long after the incubation time stated in the Instructions for Use (24 hours for example) can we incubate the BI and still have valid results?
24 hours is the minimum time at which a final negative result can be documented. Raven offers reduced incubation times for many of its products; results read at the reduced incubation times are equivalent to results at 7 days.
See Instructions For Use.
How should your products be stored?
ProPACT
ProTest BI Test Packs, ProTest Steam, ProTest EO, ProTest H2O2
ProSpore2
Spore Strips
- Storage: 15-27°C (60-80°F), 30% - 70%RH, away from sterilizing agents, direct sunlight, and all other forms of UV light. Do Not Refrigerate.
ProSpore Ampoule, ProAMP
Spore Suspensions
- Storage: Refrigerate at 2 - 8°C
ProSpore DH
- Storage: Room temperature
Industrial Use BIs:
- Storage: Cool (15-27°C, 60-80°F), 30-70%RH, away from sterilizing agents, direct sunlight and all other forms of UV light. Do Not Refrigerate.
How can I obtain a copy of your Certificate of Analysis (C of A)?
Contact: sales@ravenlabs.com
How many wells are in your various incubators?
Raven has a table top dry bath incubator available for each BI we manufacture. The number of wells depends on the specific product incubator. Click here for a complete list.
What are your product expiries?
Spore Strips have a 24 month expiry from the date of manufacture. ProTest, ProSpore Ampoule, ProSpore2, and ProAMP all have an 18 month expiry. Spore Suspensions, Culture Media, Industrial Use BI's, and ProSpore DH all have a 12 month expiry.
I had your products 3rd party tested for D-value and population and the D-value and population did not match your certificate of analysis. Does this mean that the certificate is incorrect?
No, the purpose of 3rd party testing of D-value and population is not to re-label the biological indicator’s stated values, but to confirm that the values the 3rd party lab obtains are within the USP/ISO acceptance criteria for the test. If the 3rd party lab obtains results within the acceptance criteria, then the user may accept the values as stated on the manufacturer’s certificate of analysis. For more information click here.
The positive control didn’t turn color. Does this make my test invalid?
Yes, if the positive control does not turn color, the test should be considered invalid. However, an investigation should be conducted to determine why the positive control did not turn color. The most common reasons for a positive control to not turn are 1) the biological indicators were incubated at the incorrect temperature, 2) the positive control was exposed to some type of sterilant which includes exposure to UV light through windows, or 3) the positive control and test biological indicator were inadvertently mislabeled.
When should I use a self-contained Biological Indicator rather than a spore strip?
Spore strips have been around for a long time, in fact, Raven has been manufacturing them since 1949. A spore strip is packed in a glassine envelope that is permeable to the sterilant. After exposure, the strip must be transported to a laminar flow hood for aseptic transfer into growth media.
A self-contained BI eliminates the need for aseptic transfers, and is perfect for facilities without microlabs or laminar flow hoods. ProSpore Ampoule and ProAMP are self-contained ampoules which are sealed glass ampoules containing a specific population of spores within growth media. You simply put it into an incubator after sterilization load.
ProSpore2 and ProTest are self-contained BIs in that it also requires no aseptic transfer. ProSpore2 and ProTest consist of lastics tubes containing spore discs/spore strips and an ampoule of media. After exposure to the sterilant, simply seal the unit (ProSpore 2 only) and crush the media ampoule. Incubate as directed.
How do I know which organism to use for steam/dry heat/ethylene oxide/gamma sterilization?
Steam, Chemiclave, Vapor Hydrogen Peroxide (VHP)= G. stearothermophilus (formally B. stearothermophilus)
Dry Heat, EO= B. atrophaeus (formally B. subtilus)
Gamma= B. pumilus
How often do I use BIs / how many BIs do I use per load?
The more BIs that are used, the more information one has about their particular cycle. There is no perfect number, however Raven recommends following USP/AAMI requirements:
Can I immerse the spore strip in liquid?
Spore strips are not intended to be placed into a container of liquid for monitoring a liquid load. The D-value certification for the spore strip will not be the same as when it is placed into a liquid container. This would not be its “intended use.” The effect of the liquid, its volume and content will drastically change the spore strips resistance characteristics.
A type of sealed self-contained BI should be used in liquid cycles. One that is sealed would not have its resistance characteristics affected by the liquid or its contents.
Learn more here.
How soon after running the strip do I have to transfer it?
As per USP, 4 hours.
Can I get the MSDS for X?
Yes, Learn more here.
Can I get the population assay procedure for your product?
Yes, Learn more here.
Can you send me a product catalog?
Contact Raven for product catalog information.
Is Raven FDA and/or ISO certified?
Raven Labs is an FDA registered Medical Device Manufacturer and is ISO 13485:2003 certified.
Can I buy from Raven directly?
If you are located in the United States, yes, contact us here. If you are located outside of the US, please click here for a full list of our international representatives.
Can I audit Raven’s Quality System?
Yes, contact Ms. Wendy Royalty, Quality Assurance & Regulatory Affairs
qa-ra@ravenlabs.com
Does Raven take credit card purchases?
Yes, we currently accept VISA, MasterCard and American Express.
What are your customer service hours?
8:00AM to 4:30PM CST, Monday through Friday