biocompatibility test request form demostration - wuxi … · test request form for testing...

Test Request Form For Microbiology,

Sterilization Validation,

Chemistry & Package Testing

This tutorial provides tips for completing WuXi AppTec’s

Test Request Form for testing performed at our Atlanta facility

A Test Request Form – with all applicable information completed –

is required to be included in sample shipments.

Using the HTML forms on our website ensures that you are submitting your samples

with the most current version of the form, which helps prevent possible compliance issues.

Before we begin…

A special note to clients who perform Microbiology, Sterilization

Validation, Chemistry and Package Testing at our Atlanta facility

Use of the Client Portal requires a Login assigned by WuXi AppTec.

If you do not have a Login and/or would like further information about

using our Client Portal for testing performed at our Atlanta facility,

contact your WuXi AppTec Account Manager.

As an alternative to our Test Request

Form for ordering tests at our Atlanta

facility, we offer an online Client Portal.

Data entered into the Client Portal

transmits electronically to WuXi AppTec.

A summary page is provided for printing

and including in your sample shipment.

The web-enabled/HTML Test Request

Form (covered in this tutorial) does not

transmit data to us electronically.

Table of Contents • Accessing our Web-Enabled/HTML Form

• Completing the Form

• Clearing Information from a Previous Session

• Company and Contact Information

• Sample Information

• A Note on CTP #s

• Adding and Deleting Tests

• Required Information for Particular Tests

• Special Handling / Instructions

• Sample Disposition

• 21 CFR Part 58 Testing

• Name/Date/Signing the Form

• Printing / Saving

• Correcting an Incomplete Form

• Creating Multiple In-Progress Forms

• Storing In-Progress Forms

Accessing the Form on our Website

• Go to our website: wuxiapptec.com.

• Click on the “Client Support” tab at the top and then select “Test Request/Sample Submission Forms” from the left-hand navigation panel.

• When the webpage opens, look for the “Microbiology, Sterilization Validation, Chemistry & Package Testing Test Request Form” listing and click to open it.

NOTE:

For the best experience with

our web-enabled/HTML

forms, use Internet Explorer

as your web browser.

It is crucial that you submit your samples with a Test Request Form completed in its entirety to avoid miscommunication and a possible delay in your testing.

Throughout the form are interactive text fields

check boxes and drop down menus

If any particular section or individual item does not pertain to your sample

or requested testing, be sure to check the (Not Applicable) box.

When you think you are finished, select the button.

If your form is missing required information, you will receive a message to that

effect and will have the opportunity to review the form where you will find

that incomplete sections have been highlighted for your convenience.

For more detailed information on this function, click here to access the page below.

Completing the Form

A convenient feature is that your browser will save the most recent data you have entered. Click the Reset Button in the top right corner of the form if you need to clear out information from a previous session.

Clearing Information from a Previous Session

Company and Contact Information

1. For Payment Method, select “P.O. #:” or “Attn:” and then complete.

2. Enter your Quote Number and Account Number. The quote number is in the upper right hand corner of your WuXi AppTec price quote. If you do not have an account number, contact your WuXi AppTec Account Manager.

3. Enter company name & address (if not displayed).

4. Enter contact name, phone number and email address. The contact will be the person who will receive the final report, and will also be the person contacted by the lab if there are any questions.

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1. Specify the quantity of samples that you are submitting in your shipment, including “extras.” This will be the total number samples – not the number of packages. For example, if you have 10 devices in each of 2 boxes, specify 20 samples, not 2 boxes.

2. Enter the sample name as you want it on the final report. Field is limited to 255 characters.

3. Include batch, lot or load numbers that distinguish the samples from one another (serve as the sample ID numbers). These will also be included on the final report. If you are submitting an attachment with the ID numbers, note in the field: “See attached document.”

4. Select the appropriate Safety Precautions, BSL Level and Controlled Storage Conditions.

5. Specify if the product has been submitted previously for testing. [SEE NEXT PAGE]

6. Specify if/how your sample has been sterilized.

Sample Information

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Before you start entering your requested testing,

an important note about WuXi AppTec CTP#s

If you answered “Yes”: You will be prompted to identify the CTP numbers associated with the previous tests (noted on your reports).

If you answered “No”: This area will be left blank.

How you answered this question in the previous section will determine whether a CTP# prompt will be added in the Requested Testing section.

SEE NEXT PAGE FOR ENTERING REQUESTED TESTING

Adding & Deleting Tests

TO ADD TESTS: Enter the code for a test you are ordering, hit “TAB” and the name of the test will fill in automatically.

If you have entered an invalid test code, the test name field will remain blank. To check for the correct code, access our Services for Medical Devices Catalog on our website.

TO DELETE TESTS: Select the test code you want to remove and delete it. Then hit “TAB” and the test name will also delete.

RE STAT TESTING: By requesting “STAT” *to be performed within 1 business day of receipt+, Client understands and agrees that a special fee – equal to 100% of the regular testing fee – may be assessed.

If you want to look up a test code or need information regarding sample requirements, you can click on the link provided on this form to access our Services for Medical Devices Catalog available on our website.

Required Information for Microbiology Testing

If you are ordering one or more of these tests, complete all information as required. You can find instruction for each type on the following pages.

For any of these microbiology tests that you are not requesting, check N.A.

Antimicrobial Testing

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1. Specify the time intervals.

2. Choose the appropriate test organism. In most cases, you would select “Standard,” indicating the organism(s) specified within the standard test method. If you are choosing to modify, select “Other” and then specify the organism(s).

3. Choose the appropriate inoculum population.

4. Choose the appropriate inoculum volume.

Bacterial Endotoxin Testing

1. Select “Pooled” or “Individual.”

2. Answer question as to whether inhibition/enhancement qualification has been performed on this product.

If “Yes,” advance to next section of form.

If “No,” choose whether WuXi AppTec is to perform or qualification testing is declined.

If you choose “WuXi AppTec to perform qualification” testing, include in your list of Requested Testing.

If you choose “Qualification testing declined,” your final reports will include a disclaimer statement.

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NOTE: To ensure reliability of reported results, method qualification MUST be performed.

Bioburden Testing 1. Answer question as to whether product contains antimicrobials. If “Yes,” specify the antimicrobials.

2. Answer question as to whether recovery efficiency qualification has been performed on this product.

If qualification testing has been performed, answer “Yes” and advance to next section of form.




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ID/Gram Staining

Select either “Unique Colonies Only” OR “Predominant Colony”

and then choose between “Per plate” OR “Per set of plates.”

Also for “Predominant Colony,” provide Number of Predominant Colonies.

Sterility Testing

1. Answer question as to whether product contains antimicrobials. If “Yes,” specify the antimicrobials.

2. Answer question as to whether B/F qualification has been performed on this product.

If qualification testing has been performed, answer “Yes” and advance to next section of form.




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Chemistry Testing

If you are not requesting any chemistry testing, check the N.A.s and skip this section.

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1. Select Portion to Test. If “Other” is selected, a prompt will appear to provide instructions.

2. If performing EO Residual Testing, complete all information. Note that samples for EO Residual Testing may be frozen upon receipt and tested as scheduling allows.

3. Provide Physicochemical Extraction Ratios by selecting from dropdown and supply total surface area of components being tested.

Package Testing

If you are not requesting package testing, check N.A. and skip this section.

Typical range for number of shippers in a stack is 3-6. ISTA recommends a minimum of 5 if the shipper may be warehoused in a stack for more than 24 hours during distribution; otherwise a minimum of 4 is recommended.

NOTE: If you are not over-packing shipper(s) to be tested, affix your completed Test Request Form in an envelope taped

to the outside of shipper so that contents will not be disrupted.

Provide any special handling / instructions here OR check “N.A.” and skip this section. As applicable, this space may be used to specify the portion of sample to be tested, e.g., entire device, fluid path, or specific parts or volume. Other examples of information that might be provided here:

• Sample preparation instructions

• A secondary contact

• Requests for return of special shipping materials (Fees may apply; provide courier name and account number.)

If needed, detailed instructions can be provided on a separate document and

submitted along with the Test Request Form.

Special Handling / Instructions

Use the dropdown menu to select an option for disposition of your samples after testing. There is no fee for discarding samples. If you want samples returned, a courier name and account number is required. An additional fee may apply for returns.

Sample Disposition

1. If testing is to be conducted per 21 CFR Part 58 (Non-Clinical Laboratory Study / GLP), check the box. Note that a “Required” message will be added to the Signature field at the end of the form. A protocol on file and sponsor signature on the Test Request Form submitted with your samples are required for the study to be initiated.

2. A new message and check box will automatically appear regarding characterization testing of the test article, which is a GLP requirement as specified in 21 CFR 58. By checking this box, you affirm that your test article characterization has been performed or is planned. You must then select from the dropdown regarding the availability of characterization information.

21 CFR Part 58 (Non-Clinical Laboratory Study/GLP)

If you are not conducting your testing per 21 CFR Part 58 (Non-Clinical Laboratory Study / GLP), check N.A. and skip this section.

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Enter Print Name and Date. Sign printed copy before enclosing in sample shipment.

Signature for 21 CFR Part 58 Testing

If you checked the box in the previous section to indicate you are conducting testing per 21 CFR Part 58 (Non-Clinical Laboratory Study / GLP), a note will be automatically added indicating that a signature – to be executed once you have printed out the form – is required for testing to be initiated.

Signature (and GLP Testing Authorization, if applicable)

NOTE: If you are not ready to print/sign and want to come back to the form later, you can close the form and your browser history will store the

information that you entered. The next time you open the form through your computer’s browser, you will see the input from your previous session.

Printing / Saving

Once your form is

completed, you will

need to print a copy

to include with your

shipment.

• To print or save a copy of the form, click the icon. Caution: Do not print using your browser’s print function.

• You will see a dialog box with your printer options.

• If you want simply to print a copy, select your printer and click the “Print” button.

• To save an electronic copy, select “Microsoft XPS Document Writer” as your printer and click “Print.” Choose file location, update file name, and click “Save.”

• If you have Adobe PDF Writer, you can choose that as your print option and save the file as a PDF.

If your form is incomplete, you will get a warning message. SEE NEXT PAGE

Click “Cancel” and you will be taken back to the beginning of the form for review.

Scrolling through the form, you will find that incomplete sections have been highlighted.

Complete all of these sections and when you again select the “Print/Save” button, the warning message and highlighting will be gone.

If your form is incomplete when you try to “Print/Save,” you will get a warning message and an option to select “OK” or “Cancel.”

Correcting an Incomplete Form

If you click “OK” (to print/save the form even though it is incomplete), your form will print with a message at the top that states it is not ready for submission to WuXi AppTec.

TIP: A section may be highlighted as

incomplete because you failed to select

“N.A.” for items that are not applicable to

your test article or requested testing.

If you are working on one form and want to have a second form open at the same time, have your browser open a new tab/window. (This will display your browser’s home page). Copy the URL from the address bar in the tab/window of your original form and paste it into the address bar of your new tab/window. Then, type a “2” immediately after the first “trf” in the address bar — ... trf2.apptecls.com... — and click “Go” or hit your return key. A new form will open. To open additional forms, follow these same steps and change the “2” in the browser address bar to the next available — “3” or “4” or “5” — up to a total of 5.

Form #1: http://trf.apptecls.com/TRF/TRF/MicroChemPkg

Form #2: http://trf2.apptecls.com/TRF/TRF/MicroChemPkg




Creating Multiple In-Progress Forms

A convenient feature is that you can store up to 5 multiple versions of the form (URLs) in your browser’s “Favorites” if you are filling out several at a time. [SEE NEXT PAGE]

http://trf.apptecls.com/TRF/TRF/MicroChemPkg

http://trf2.apptecls.com/TRF/TRF/MicroChemPkg








1. Click on your “Favorites” icon. (Using Internet Explorer, it will be the star located in the upper right corner of your web browser window.)

2. Select “Add to Favorites.”

3. Name the current form and click “Add.”

4. Your “Favorites” listings will now include

the added form.

Additional versions of in-progress forms

can be similarly added to your Favorites

– using different names – enabling easy

access to each.

Storing In-Progress Forms

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Thank you from all of us at

WuXi AppTec for entrusting us

with your important testing.

If you have any questions, please

contact your WuXi AppTec Account Manager.

biocompatibility test request form demostration - wuxi … · test request form for testing...

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