Biocompatibility Test Request Form

Transcription

1 Biocompatibility Test Request Form This tutorial provides tips for completing WuXi AppTec s Biocompatibility Test Request Form in HTML format. A separate form with all applicable information completed is required to be included in the shipment for each type of test article being submitted. 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.

2 Table of Contents Accessing the Form on Our Website Completing the Form Clearing Information from a Previous Session Providing Client Information and Importing Data from your Quote Adding and Deleting Tests Protocol Version and Effective Date Test Article Information Test Article Preparation and Extraction Comparison / Control Article Information Testing Authorization & Protocol Approval Final Reports Option Printing / Saving Correcting an Incomplete Form Creating Multiple In-Progress Forms Storing In-Progress Forms

3 Accessing the Form on our Website NOTE: For best experience with our web-enabled/html forms, use Internet Explorer as your web browser. 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 Biocompatibility Test Request Form listing and click to open it.

4 Completing the Form It is crucial that you submit your test article 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 test article 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.

5 Clearing Information from a Previous Session 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.

6 Providing Client Information and Importing Data from Your Quote For Payment Method, select P.O. #: or Attn: and then complete. 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.) One of the advantages of WuXi AppTec s web-enabled forms is the ability to access information directly from our databases. When you enter your quote number and account number, your company name and address will automatically populate. You will also see a pop-up window where you can choose to have the tests from your price quote automatically populate. If you choose not to use this auto-fill feature, select Cancel and the Requested Testing section will remain blank for you to complete.

7 Check the Auto-Filled Content and Add Contact information On the example shown, company name and address as well as test codes and names have been populated. Check the auto-filled company information and add a contact name, phone number and address. (The contact name 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.) If you have chosen to have tests imported from your quote, review the listed entries. You may add and delete tests as needed. [SEE NEXT PAGE] NOTE: The first page of the form has space for 8 tests. If your quote has more than 8 tests, the form will automatically add another page of test listings. Alternatively, if you need more space for adding tests, click the Check here if more space is needed box and an additional Requested Testing page will appear.

8 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. TO DELETE TESTS: Select the test code you want to remove and delete it. Then hit TAB and the test name will also delete. 1. For any test coded to be performed according to GLP guidelines, a protocol version number and effective date will automatically appear below the test code/name fields. [SEE NEXT PAGE] 2. For tests that are not GLP, a Not GLP will appear under the test code. A protocol version number and effective date will not display because protocols are not required. 3. If you have entered an invalid test code, the test name field will remain blank. 4. For custom assays (test codes beginning with a C ), the test name field will be blank for you to enter the test name. To check for correct test codes, use the CLICK HERE link to access our Services for Medical Devices Catalog on our website.

9 Protocol Version and Effective Date for GLP Studies For any test coded to be performed according to GLP guidelines, a protocol version number and effective date will automatically appear below the test code and test name fields. If you are ordering GLP testing, see page 21 for information on protocol review and approval.

10 Provide Test Article Information 1. Specify the quantity of test articles that you are submitting in your shipment. This will be the total number test articles not the number of packages. For example, if you have 10 devices in 2 boxes, specify 20 test articles, not 2 boxes. 2. A sample requirements guide can be accessed by clicking on the link. You will be able to view a pdf chart that provides guidance regarding sample requirements for various types of testing. [SEE NEXT PAGE] 3. Enter the test article name as you would like to see it on the final report. This field is limited to 255 characters. 4. The lot number field is limited to 25 characters. 5. Enter the test article s expiration date. Or, if not applicable, enter N.A. If you have various lot/id numbers and/or expiration dates, check the Various box and include a separate document with your test request form in the sample shipment.

11 Guide to Sample Requirements for Biocompatibility Testing This PDF chart is designed as a quick guide to sample requirements for some of our most commonly order tests. It can be accessed by clicking on the link in the Biocompatibility Test Request Form. A link to it is also located on the test request form page on our website.

12 Test Article Information [continued] The Physical Description should be a general description of the test article. It will be included in the final report. (OPTIONAL) 7. In the Intended Use / Application section, describe how the test article will be used in a clinical setting. (OPTIONAL) Select the appropriate Physical State, Safety Precautions and Controlled Storage Conditions from the dropdown menu options provided. 9. Specify if/how your test article has been sterilized.

13 Test Article Characterization The Test Article Characterization section is required for tests that are to be performed according to Good Laboratory Practices (GLP) regulations (21 CFR 58). By checking this box, you affirm that your test article characterization has been performed or is planned.

14 Test Article Disposition In the Test Article Disposition section, you can choose to have test articles discarded or returned once testing is completed. If you want them returned, a courier name and account number is required.

15 Test Article Handling & Preparation Any handling and preparation instructions can be captured here, as shown in above example. Other examples might be: Exclude handle Must be extracted immediately upon opening package For fluid path extraction, fill with 100ml of extract and clamp ends 2. If there are no handling or preparation instructions, check the N.A. box. 3. Use the dropdown option to indicate if the device can be cut for extraction. NOTE: Test articles are typically cut into smaller pieces. If there are materials inside the test article that should not be exposed to the extract, choose the Do NOT cut option. If needed, provide additional information in the Preparation Requirements/Instructions section. 4. Specify if the test article is absorbent. If it is, we ll perform a pretest to determine the absorption capacity. The extract volume will be adjusted accordingly.

16 Extraction Parameters The extraction parameters section will be specific to the tests you ve requested or the test article being submitted. Ensure that you are consistent with ISO recommendations. 1. If no extraction tests are being requested for example, if you are requesting an implant or a skin patch test check the N.A. box to populate the fields with Not Applicable. 2. The type of extract will depend on the tests that we will be performing. Choose the appropriate extracts if requesting any of the tests listed here. 3. The extraction ratio will depend on the size and shape of your test article. Include the surface area or weight of one device in the pop-up field below the ratio. If submitting test articles of various sizes, check the Various box. Include their surface area or weight with their unique identifier on a separate sheet attached to the Test Request Form in your shipment. 4. Choose the extraction conditions appropriate for your test article. Again, this applies to all tests that require extraction except cytotoxicity and direct contact hemolysis.

17 Hemocompatibility Tests Click the N.A. box if you are not requesting these tests. 2. Specify the direct blood contact portions here if the entire test article does not need to be included. If you have a device that has multiple components, such as a delivery device, you might specify, for example, the distal portion only. 3. These PTT, Platelet & Leukocyte Count ratios are standard but a ratio needs to be selected for Complement Activation. 4. Depending on the size and shape of your device, select appropriate ratio and conditions for the Hemolysis test.

18 MHLW (Japan) Tests Extraction parameters for MHLW (Japan) tests are the same as for ISO/ASTM except for the specific tests identified on the form genotoxicity, sensitization, cytotoxicity and hemolysis. These require extraction parameters specific to their test methods. 1. Click the N.A. box unless you have listed MHLW cytotoxicity and/or hemolysis tests in your Requested Testing. 1. Complete this section if you are requesting the MHLW test method for cytotoxicity. 2. Complete this section if you are requesting the MHLW test method for hemolysis.

19 Submitting Comparison / Control Articles If submitting comparison or control articles, click on the box to check it. An additional page will appear for you to provide all the specific details. The fields on this page are similar to those for the test article. Complete all fields as necessary.

20 Comments Include in the comments section any additional instructions or details that might be important to communicate to the lab. Examples might be a secondary contact, a request for a preliminary report, or an inquiry regarding possible STAT testing.

21 Testing Authorization & Protocol Approval Enter Print Name and Date. Note that an actual signature to be executed once you have printed out the form is required for testing to be initiated. 2. If you are ordering GLP testing, the form will automatically add a message here which states that, in addition to testing authorization, your signature also signifies your review and approval of any applicable test protocols (as listed with the requested tests). 3. If there are protocols you need to review before signing, use the click here link to us your request for copies. NOTE: If you are not ready to 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.

22 Final Reports Option For your convenience and to reduce environmental impact we offer the option of choosing not to receive a hard copy of your final reports. Be sure to check the box that indicates your preference. Note that the original hard copy of the report will be archived at WuXi AppTec and can be sent to you at any time upon request.

23 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.

24 Correcting an Incomplete Form 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. 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 you click OK (to print/save the form even though it is incomplete), your form will print/save 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.

25 Creating Multiple In-Progress Forms 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, changing the 2 in the browser address bar to the next available 3 or 4 or 5 up to a total of 5. Form #1: Form #2: Form #3: Form #4: Form #5: A convenient feature is that you can store multiple versions of the form (URLs) in your browser s Favorites if you are filling out several at a time. [SEE NEXT PAGE]

26 Storing In-Progress Forms 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. 4 Additional versions of in-progress forms can be similarly added to your Favorites using different names enabling easy access to each.

27 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.