Release Testing The Release Test is performed according to the assay conditions and dilutions used during the Test for Interfering Factors and is used to release finished prod- uct. The test can also be performed for release of raw/ in-process materials. Release testing can be performed in accordance with USP, EP, and/or JP, depending on the specifications of the client. Sending Samples A Sample Submission Form (SSF) must be completed and accompany each sample sent for testing. Sample Submission Forms can be obtained from our website at www.acciusa.com/cts/index.html or by calling CTS (U.S. office (888) 232–5889 or U.K. office (44) 151-547-7444). Custom Services CTS offers a variety of services that are customized to meet each client’s individual requirements. Method Development Some samples or devices interfere with the BET tests and a method must be developed in order to be able to perform a valid test for endotoxin. CTS will determine how best to prepare the sample for testing. We can also perform testing to validate any sample pre-treatment used in the test method. Method Transfer Many companies have sufficient testing volume to justify performing the assay in-house. For these customers, Associates of Cape Cod, Inc. supplies a complete line of the highest quality BET reagents. CTS supports this line by working with companies to develop and optimize methods to test their products. CTS also helps custom- ers convert from one methodology to another, e.g., from testing by the gel-clot method to chromogenic or turbidimetric assays. The methods developed by CTS are then transferred to the client for use by their own QC laboratories. Your company gets the assurance that the method will work well with your products.
Custom Depyrogenation Controls CTS will make custom depyrogenation controls using the same items normally processed in your oven and provide a Certificate of Analysis for the articles. The controls are then used to demonstrate at least a three-log reduction by your oven cycle. CTS can also test items post-depyro- genation to verify your oven cycle performance. Contact Information For information on services provided and laboratory qualifications please contact your local office.
U.S. Office Contract Test Service at
Associates of Cape Cod, Inc. 124 Bernard E. Saint Jean Drive East Falmouth, MA 02536-4445 Tel: (888) 232–5889 or (508) 540–3444 E-mail: testservice@acciusa.com Hours of Operation Monday through Friday, 8:00 a.m. to 5:00 p.m. EST UK - Associates of Cape Cod International, Inc. Deacon Park, Moorgate Road, Knowsley, Merseyside, L33 7RX, United Kingdom Tel: (44) 151-547-7444 E-mail: info@acciuk.co.uk Hours of Operation Monday through Friday, 9:00 a.m. to 5:00 p.m. Europe - Associates of Cape Cod Europe GmbH International Proficiency Test available Opelstrasse 14 D-64546 Mörfelden-Walldorf, Germany Tel: (49) 61 05–96 10 0 E-mail: service@acciusa.de Hours of Operation Monday through Thursday, 8:00 a.m. to 5:00 p.m. Friday, 8:00 a.m. to 3:00 p.m.
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