[ACC] Product Overview

SUPPORT SERVICES

ACC offers its customers extensive technical support. Our Technical Service department is staffed with experienced professionals who provide customer assis- tance for the full range of ACC products and services. Technical support is available by telephone, email, and in person, through workshops, on-site training, or on-site consultation. Customers who have questions about individual products, test methods, instrumenta- tion, and/or software are invited to call our staff. Software Validation Protocols ACC offers Validation Protocols that provide the end user with a comprehensive set of integrated documents to guide them through the system valida- tion process. The protocol files allow users to edit the documents to meet their company’s specific validation requirements. Reagent Transfer Protocol The Reagent Transfer Protocol document (RTP) is used to validate the change from another manufacturer to ACC BET reagents. If changing BET reagent man- ufacturers, ACC offers assistance with guidance and instructions for using the Validation Protocol. This can be used as verification of the validation process. The Reagent Transfer Protocol is designed to assist users in completing validation of their switch from the current BET reagent to an ACC product. During this process, if the user requires any assistance you will be able to obtain help and advice through the Technical Services department of ACC. Expertise and Resources Assistance with selecting a test method or reagent sensitivity is always available from our Technical Service Department, and representatives in the field. Our staff can help with Preliminary Testing, Testing for Interfering Factors or Routine Testing. The LAL Update ® , our newsletter, includes useful technical articles and is available on our website. Our Contract Test Service (see page 33) team regularly performs Preliminary Testing and method development and can provide results using all test methods. Regardless of which method is selected, you can always be assured of the full support of Associates of Cape Cod, Inc.

For details on endotoxin testing in the United States, users should consult the current revision of the United States Pharmacopia (USP), chapter <85>, “Bacterial Endo- toxins Test”. For those testing outside the US you should consult your local regulatory requirements for the BET. On-Site Consulting Services ACC staff is available to visit client sites to assist investigations and troubleshooting. These visits often address Bacterial Endotoxin Testing (BET) procedures, in addition to identifying sources of contamination in test laboratories and manufacturing processes. #CSOS01 On-site Consulting Services (per day) #SCOS01 On-site Service Call (per day)

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