Biocompa(bility Test Request Form

Transcription

1 Biocompa(bility Test Request Form This tutorial provides (ps for comple(ng WuXi AppTec s Biocompa(bility Test Request Form in HTML format. A separate form with all applicable informa(on completed is required to be included in the shipment for each lot and/or type of sample being submiged. Using the HTML forms on our website ensures that you are submiing your samples with the most current version of the form, which helps prevent possible compliance issues.

2 Table of Contents Accessing the Form Clearing Informa4on from a Previous Session Impor4ng Data from your Quote Adding and Dele4ng Tests Protocol Version and Effec4ve Date Test Ar4cle Informa4on Test Ar4cle Prepara4on and Extrac4on Comparison / Control Ar4cle Informa4on Tes4ng Authoriza4on & Protocol Approval Prin4ng / Saving Crea4ng & Comple4ng Mul4ple In- Progress Forms Storing Mul4ple In- Progress Forms

3 Accessing the Form on our Website 1. Go to our website: wuxiapptec.com. 2. Click on the Client Support tab at the top and then select Test Request/Sample Submission Forms from the let- hand naviga4on panel. 3. When the page opens, click on the Biocompa4bility Test Request Form. NOTE: For best experience with our web- enabled/html forms, use Internet Explorer as your web browser.

4 Clearing Informa(on from a Previous Session A convenient feature is that your browser will save the most recent data you have entered. Click the Reset BuGon in the top right corner of the form if you need to clear out informa4on from a previous session.

5 Impor(ng Data from Your Quote Enter your PO number, your Quote Number and your Account Number. (You can find the quote number on 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 informa4on directly from our databases. When you enter your quote number and account number, your company name and address will automa(cally populate. You will also see a pop- up window where you can choose to have the tests from your price quote automa(cally populate. If you choose not to use this auto- fill feature, select Cancel and the Requested Tes4ng sec4on will remain blank for you to complete.

6 Check the Auto- Filled Content and Add Contact informa(on On the example shown, company name and address as well as test codes and names have been populated. Check the auto- filled company informa4on 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 quesfons.) 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 automafcally add another page of test lisfngs. AlternaFvely, if you need more space for adding tests, click the Check here if more space is needed box and an addifonal Requested TesFng page will appear.

7 Adding & Dele(ng Tests 1! 2! 3! 4! TO ADD TESTS: Enter the code for a test you are ordering, hit TAB and the name of the test will fill in automa4cally. 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 effec(ve date will automa4cally appear below the test code and 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 effec4ve 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. To check for the correct code, click here to access our Services for Medical Devices Catalog on our website. 4. For custom tests (which have a C before the test code), the test name field will be blank for you to enter the test name.

8 Protocol Version and Effec(ve Date for GLP Studies For any test coded to be performed according to GLP guidelines, a protocol version number and effec(ve date will automa4cally appear below the test code and name fields. If you are ordering GLP tes4ng, a message will automa4cally be added to the end of the form sta4ng that in addi4on to tes4ng authoriza4on, your signature also signifies your review and approval of any applicable test protocols. If there are protocols you need to review before signing, use the click here link provided in the message to a request for copies.

9 3! 1! 2! 4! 5! Provide Test Ar(cle Informa(on 1. Specify the quan(ty of test ar(cles that you are submicng in your shipment. This will be the total number test ar4cles not the number of packages. For example, if you have 10 devices in 2 boxes, specify 20 test ar4cles, 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 tes4ng. [SEE NEXT PAGE] 3. Enter the test ar(cle 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 ar4cle s expira(on date. If you have various lot/id numbers and/or expirafon dates, you can include them in the test arfcle name field or on a separate document to be included with your test request form in the sample shipment.

10 Guide to Sample Requirements for Biocompa(bility Tes(ng 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 Biocompa4bility Test Request Form. A link to it is also located on the test request form page on our website.

11 Test Ar(cle Informa(on [confnued] 6! 7! 6. The Physical Descrip(on should be a general descrip4on of the test ar4cle. It will be included in the final report. 7. In the Intended Use / Applica(on sec(on, describe how the test ar4cle will be used in a clinical secng. 9! 8! 8. Select the appropriate Physical State, Safety Precau(ons and Controlled Storage Condi(ons from the dropdown menu op4ons provided. 9. Specify if/how your test ar4cle has been sterilized.

12 Test Ar(cle Characteriza(on The Test Ar(cle Characteriza(on sec4on is required for tests that are to be performed according to Good Laboratory Prac4ces or GLP. By checking this box, you affirm that your test ar4cle characteriza4on has been performed or is planned. This is a GLP requirement as specified in 21 CFR 58.

13 Test Ar(cle Disposi(on In the Test Ar(cle Disposi(on sec4on, you can choose to have any remaining test ar4cles discarded or returned once tes4ng is completed. If you want them returned, a courier name and account number is required.

14 Test Ar(cle Handling & Prepara(on 1! 3! 2! 4! 1. If there are no handling or prepara4on instruc4ons, check the NA box. 2. Any handling and prepara(on instruc(ons 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 extrac4on, fill with 100ml of extract and clamp ends 3. IMPORTANT: Test ar4cles are typically cut into smaller pieces for the extrac4on process unless this box is checked. If there are materials inside the test ar4cle that should not be exposed with the extract, check the Do not cut test ar(cle box. If needed, provide addi4onal informa4on in your Prepara4on Requirements/Instruc4ons. 4. Specify if your test ar4cle is absorbent. If it is, we ll perform a pretest to determine the absorp4on capacity. The extract volume will be adjusted accordingly.

15 Extrac(on Parameters 2! 1! 3! 4! The extracoon parameters secoon will be specific to the tests you ve requested or the test arfcle being submiwed. Ensure that you are consistent with ISO recommendafons. 1. If no extrac4on tests are being requested for example, if you are reques4ng an implant or a skin patch test check the NA 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 reques4ng any of the tests listed here. 3. The extrac(on ra(o will depend on the size and shape of your test ar4cle. Include the surface area or weight of one device in the pop- up field below the ra4o. NOTE: If submitng samples of various sizes, include their surface area or weight with their unique idenffier on a separate sheet awached to the Test Request Form in your shipment. 4. Choose the extrac(on condi(ons appropriate for your test ar4cle. Again, this applies to all tests that require extrac4on except cytotoxicity and direct contact hemolysis.

16 Hemocompa(bility Tests 1! 2! 3! 4! 1. Click the NA box if you are not reques4ng these tests. 2. Specify the direct blood contact por(ons here if the en4re test ar4cle does not need to be included. If you have a device that has mul4ple components, such as a delivery device, you might specify, for example, the distal por4on only. 3. These PTT, Platelet & Leukocyte Count ra4os are standard but a ra4o needs to be selected for Complement Ac(va(on. 4. Depending on the size and shape of your device, select appropriate ra4o and condi4ons for the Hemolysis test.

17 MHLW (Japan) Tests 1! 2! 3! Extrac4on parameters for MHLW (Japan) tests are the same as for ISO/ASTM except for the specific tests iden4fied on the form genotoxicity, sensi4za4on, cytotoxicity and hemolysis. These require extrac4on parameters specific to their test methods. 1. Click the NA box unless you have listed MHLW cytotoxicity and/or hemolysis tests in your Requested Tes4ng. 2. Complete this sec4on if you are reques4ng the MHLW test method for cytotoxicity. 3. Complete this sec4on if you are reques4ng the MHLW test method for hemolysis.

18 SubmiIng Comparison / Control Ar(cles If submicng comparison or control ar(cles, click on the box to check it. An addi4onal page will appear for you to provide all the specific details. The fields on this page are similar to those for the test ar4cle. Complete all fields as necessary.

19 Comments Include in the comments sec4on any addi4onal instruc4ons 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 tes4ng.

20 Tes(ng Authoriza(on & Protocol Approval 3! 2! 1. Enter Print Name and Date. Note that an actual signature to be executed once you have printed out the form is required for tes4ng to be ini4ated. 2. If you are ordering GLP tes4ng, the form will automa4cally add a message here which states that, in addi4on to tes4ng authoriza4on, 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 at: STPSampleReceiving@wuxiapptec.com 1! 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 informafon that you entered. The next Fme you open the form through your computer s browser, you will see the input from your previous session.

21 Prin(ng / 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. You will see a dialog box with your printer op4ons. If you want simply to print a copy, select your printer and click the Print buoon. To save an electronic copy, select MicrosoT XPS Document Writer as your printer and click Print. Choose file loca4on, update file name, and click Save. If you have Adobe PDF Writer, you can choose that as your print op4on and save the file as a PDF.

22 Crea(ng & Comple(ng Mul(ple In- Progress Forms If you are working on one form and want to have a second form open at the same 4me, 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 ater 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 addi4onal 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: hop://trf.apptecls.com/trf/trf/biocompa4bility Form #2: hop://trf2.apptecls.com/trf/trf/biocompa4bility Form #3: hop://trf3.apptecls.com/trf/trf/biocompa4bility Form #4: hop://trf4.apptecls.com/trf/trf/biocompa4bility Form #5: hop://trf5.apptecls.com/trf/trf/biocompa4bility A convenient feature is that you can store mulfple versions of the form (URLs) in your browser s Favorites if you are filling out several at a Fme. [SEE NEXT PAGE]

23 Storing In- Progress Forms 2! 3! 1! 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 lis4ngs will now include the added form. 4! AddiFonal versions of in- progress forms can be similarly added to your Favorites using different names enabling easy access to each.

24 Thank you from all of us at WuXi AppTec for entrusfng us with your important tesfng. If you have any quesfons, please contact your WuXi AppTec Account Manager.