I am getting a security warning the first time I open a request form. What does this mean?
These request forms contain macros to facilitate your
selection of options. The displayed security warning confirms that all macros
within the request form were developed by Biotest Laboratories, Inc. Biotest
Laboratories has been issued a developer certificate by a Microsoft
recognized certificate authority. When you select 'Always trust macros
from this publisher' and click 'Enable Macros', you are stating that you trust
Biotest Laboratories as the developer of the macros. This allows you to
keep your macro security settings as needed while being able to run the request
form.
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How can the TRFs be submitted electronically?
The TRFs can be submitted via email to
lab@biotestlabs.com after they are printed, signed, and scanned.
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Why is it important to use a consistent naming convention when
referencing my Product samples?
The Product name is key to determining the testing method, potential
results, and trending. Consistent naming of Products speeds the pace at which your
samples can be placed on test and minimizes turnaround time.
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My Product name does not fit in the space provided.
Enter See Special Instructions in the
'Product Name' field and
enter the complete Product name in the 'Special Instructions' field.
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My lot numbers do not fit in the lot numbers fields
(Sterile Lot number, Sterilization Lot number, Product Lot number, Lot number).
To assure traceability of each of your samples, it is important
that each lot number is recorded. Type See Special Instructions in the
applicable fields
and enter the lot numbers in the 'Special Instructions' field.
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What is my company Account Code?
A unique account code is assigned to all Biotest Laboratories,
Inc. clients to assure confidentiality. Please contact Biotest Laboratories, Inc. at 736.404.7170 to obtain your
company's Account Code.
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What is the purpose of the New / Changed Contact Information checkbox?
The checkbox notifies Biotest Laboratories that the reports are to be
sent to a location different than previous sample submissions.
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Why is there only one phone number field and why is it at the bottom of the TRF?
The phone number being requested is that of the person(s) who is
most familiar with the samples being submitted, the testing requested, and has
the authority to make decisions regarding the submitted sample, confirmatory
testing, or notified of results that exceed limits. This individual will be
contacted with any questions or concerns that may arise during the course of the
testing.
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What is a MMEL code?
There will be a code assigned to each item (product, cleanbench,
or cleanroom) that is routinely tested to allow tracking in the Managing
Microbes database system. The MMEL code allows a unique item to be associated
with limits, results, validations, and other associated information. Contact Biotest Laboratories at
763.315.1200 for more information on MMEL codes.
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How do I request serial numbers or individual product identifiers on my report?
Please indicate in the 'Special Instructions' field that serial numbers or product
identifiers should be recorded.
Note that it may be difficult to ascertain which products belonged to which sample number
after testing is performed.
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How do I select a checkbox with my keyboard?
Select the checkbox by pressing 'space' on your keyboard, or click the mouse.
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How do I order multiple tests with a limited number of samples?
Please contact the laboratory at 763.315.1200 to process these requests.
Some testing may be performed concurrently, and some tests require different samples per test.
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How do I know when samples will be delivered to the laboratory?
Delivery time is dependent on the delivery method and applicable
aeration times for ethylene oxide sterilized products. Holidays and/or weekends
may also impact the delivery dates of the carrier. Please take these factors
into account when planning testing.
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What is the 'Sampling Bldg/Room'?
The 'Sampling Bldg/Room' is the location (building or room) the
product was manufactured in, or the location from which the sample was taken.
Microbial Management is a process in which Biotest Laboratories associates
the environmental and product data. Adding the 'Sampling Bldg/Room' information
allows Biotest Laboratories to assist you in increasing awareness of all
variables impacting your product's quality by correlating environmental and
product data through the Microbial Management system.
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How can I install the Test Request Forms when I get an error message about policies that prevent installation?
The message below is shown when a user does not have sufficient
privileges to
install software on their computer. Contact your IS administrator about installing the
Test Request Forms, or contact Biotest Laboratories for alternate installation methods.
What is/are the most recent version(s) of the Test Request Forms?
| Form Title | Version Number |
|---|
| Antimicrobial Effectiveness | 1.1 |
| Chemistry | 1.1 |
| Cleanbench | 1.1 |
| Endotoxin | 1.2 |
| Environmental Monitoring | 1.1 |
| Ethylene Oxide Residue | 1.2 |
| Liquid Bioburden | 1.3 |
| Microbial Limits Products | 1.1 |
| Microbial Limits Water | 1.1 |
| Microbiology Supply | 1.2 |
| Microbiology | 1.1 |
| Product Bioburden | 1.2 |
| Sterility | 1.2 |
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How many products should I send for Product Sterility testing (Native Product testing)?
Refer to Table 1 and Table 2 in USP <71> to determine quantity based on product type or lot size. The preference is for samples to be divided so that equal portions of sample are added to each
specified media type. However, if the samples cannot be divided evenly then twice the number of samples as indicated in Table 1 and Table 2 is recommended.
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What is the difference between 'Sterilization Lot' and 'Sterile Lot'?
Sterilization Lot is the number assigned by the contract sterilization
vendor. The Sterile Lot is the number that may be assigned by the OEM to the product
or batch of products that have been sterilized together.
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When should I choose 'Inoculated' versus 'Native' for my bioburden validation?
Biotest Laboratories recommended practice is to choose the Inoculated method. Exceptions
may be if routine testing is going to be performed on the same products at the same time
as the validation. If 'Inoculated' is chosen it is recommended that the products be
sterilized before submission, if possible.
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Why is a certificate needed for biological indicator population verification testing?
The biological indicator (BI) certificate contains the information
against which the population verification test results will be compared. Provide a
certificate with the submission of samples to minimize turn around time. Samples
will be placed on hold until a certificate can be obtained.
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How do I know if my BI meets the required population?
The manufacturer must state the viable population on the BI; this
number is then considered the listed population. According to the various ISO
standards (11138 series) and USP monographs the populations for the various BIs
must be as follows:
- ISO (11138 series) population requirements:
- EO (Ethylene oxide): ≥ 1.0 x 106 (11138-2 9.3)
- Moist heat: ≥ 1.0 x 105 (11138-3 9.3)
- Dry heat: ≥ 1.0 x 106 (11138-4 9.3)
- Low temp steam & formaldehyde: ≥ 1.0 x 105 (11138-5 9.3)
- USP monographs population requirements:
- Paper Carrier BIs used for EO, Steam, or Dry Heat: > 1.0 x 104 and < 1.0 x 109
- Liquid Spore Suspension used for Moist heat, Dry heat, & Gaseous modes of
sterilization: > 1.0 x 103 and < 1.0 x 109
- Nonpaper carriers used for Moist heat, Dry heat, & Gaseous modes of
sterilization: > 1.0 x 103 and < 1.0 x 109
It is a generally recommended practice to have an independent population
verification test performed. For this testing there are listed acceptance criteria.
ISO 11138-1:2006 6.3.2 states that “The viable count shall be between 50% and 300% of
the manufacturer’s stated value when it is determined by the manufacturer or a third
party during the stated shelf life using the method specified by the manufacturer.”
ISO 14161:2000 11.2 clarifies that “When tested, the … [population] can be higher or
lower than the labeled number because variations in testing procedures can influence
the resulting data.” USP BI monographs also states acceptance criteria: “not less than
0.3 log of the labeled spore count per carrier … and does not exceed the log labeled
spore count per carrier by 0.48.” which is roughly -50% to +300%.
The test for population verification is used to confirm the manufacturer’s listed
population and the verification result is not to be referenced as the actual BI
population. The manufacturer’s population is considered verified when the confirmatory
data achieves the limits referenced above.
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What is the difference between the 'Date Testing Requested' and 'Date
Testing Performed' fields?
The 'Date Testing Requested' field is used to assist us in scheduling
your testing when performed by Biotest Laboratories, Inc. technicians. The 'Date Testing
Performed' field is used to identify when the tests were actually performed.
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What should I put down for the 'Person(s) who Performed Testing' field?
The 'Person(s) who Performed Testing' field is intended to identify the
person(s) performing the testing. For example, if you are requesting testing to be
performed by Biotest Laboratories, Inc. enter “Biotest” in this field. If you or someone
in your company is performing the testing enter your/their name(s). If the person(s)
performing the testing is/are unknown, then entering your company name is acceptable.
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