SERVICES

Medical Device Industry
Biocompatibility (in vitro and in vivo), genotoxicology, hemocompatibility, chemistry, quality assurance support/monitoring of manufacturing processes, full-service microbiology, package testing, sterilization validation, reusable device validation, viral clearance, and environmental testing. 

Biotechnology and Biopharmaceutical Industries
GLP- and GMP-compliant testing in the areas of cell line characterization, viral/process validation, gene therapy vector testing, molecular biology, mycoplasma testing, and analytical services. Also cGMP cell banking services. 
AppTec publishes a separate catalog of testing services for the biotechnology/biopharmaceutical industries, which will soon be available online as well.

FACILITIES

St. Paul, Minnesota
AppTec’s St. Paul facility serves as the company’s corporate headquarters. A 33,000-square-foot, technologically advanced building, it houses FDA-registered, ISO-certified laboratories for in vitro testing services, in life studies, genotoxicology,  and toxicology testing, as well as cell banking services for the biologics industry.

Atlanta, Georgia
Located in a 17,000-square-foot facility, this FDA-registered, ISO-certified lab performs microbiology and chemistry testing for the medical device industry and other related industries, with a specialization in radiation sterilization validation studies and dose audits.Camden, New Jersey
Occupying 30,000 square feet of laboratory and office space in the suburbs of Philadelphia, this FDA-registered laboratory specializes in biosafety testing for the biotechnology and biopharmaceutical industries, as well as viral clearance studies for biopharmaceuticals and biomaterials.

Camden, New Jersey
Occupying 30,000 square feet of laboratory and office space in the suburbs of Philadelphia, this FDA-registered laboratory specializes in biosafety testing for the biotechnology and biopharmaceutical industries, as well as viral clearance studies for biopharmaceuticals and biomaterials.

QUALITY ASSURANCE
Every aspect of AppTec’s operations is governed by a focus on quality assurance and quality control. A highly trained, internal quality assurance unit monitors all testing to assure accuracy, precision, reliability and timeliness. A continuous quality improvement process is in place to review any discrepancies and make improvements that will constantly and consistently enhance the quality of our service.

STAFFING
Our staff prides itself on being the vital, dedicated human resource for expertise that enhances every service we offer. All personnel are qualified and experienced professionals. Senior technical staffing includes experts who are nationally recognized in their fields. All division directors and laboratory supervisors are highly trained with many years of experience. A well-organized and experienced reporting unit is staffed by personnel skilled in data transfer, and proficient in handling both high-volume reporting and the demands of rapid turnaround times.

Information for Clients

SAMPLE SUBMISSION
Each sample sent to AppTec for testing must be accompanied by the appropriate paperwork in order for testing to be initiated. (See note below on Test Request Forms.) 
Where you will be submitting your sample depends on the test, as different tests are performed at AppTec’s three facilities. See this catalog’s test listings for guidance or contact your Account Manager.
NOTE: As a general rule, to expedite certain testing, samples for radiation sterilization and chemistry testing (including EO residual testing) are best sent directly to the Atlanta facility. Samples for biocompatibility, EO sterilization validation and reusable device testing are best sent directly to the St. Paul facility. Samples for package testing should be sent directly to the Camden facility. 

TEST REQUEST FORMS
AppTec test request forms to accompany your samples are available in pre-printed format (for you to make copies of and fill in as necessary) or in electronic format
(a PDF form) that you can complete on your computer and print out. 
To receive personalized test request form(s), contact your Account Manager or email This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .
NOTE: In completing the test request form, clients should take care to provide specific wording for the sample description that will be used in the test reports. 

SAMPLE TRANSPORTATION
How a sample is shipped (e.g., overnight air) is dependent on the nature of the sample and the type of testing. Some tests require that samples receive special shipping and handling (e.g., environmental water and some chemistry tests). See individual test listings or contact Client Services.
For local courier service within the metro areas of Minneapolis/St. Paul or Atlanta, contact the appropriate facility. 

GLP
All AppTec operations are performed according to applicable good laboratory and good manufacturing practices. Certain studies for submission to regulatory bodies must be performed according to GLP (Good Laboratory Practices) regulations. GLP services are available at the client’s request and entail additional fees.
NOTE: For GLP tests, a protocol signed by the client must be in place at AppTec prior to test initiation. Contact your Account Manager for more information. 

TURNAROUND TIME (TAT)
Most test listings in this catalog provide an estimated turnaround time, which is calculated as the time from log in of your test article at the testing facility to the time your final report is issued. Except where noted, these turnaround times are for testing that does not include GLP.
NOTE: GLP testing requires additional time and clients will be notified as to the date they can expect to receive their final reports.

STAT REQUESTS
Arrangements can be made with the testing facility to accommodate stat testing whenever possible. An additional fee equal to 50% of the test price will be charged for this service.

CUSTOMIZED TESTING
AppTec is uniquely qualified to assist clients with special testing needs. Our scientists draw on many years of experience in the medical device field and provide exceptional expertise in performing assays in accordance with FDA, ISO, GMP and GLP guidelines.

CONSULTATION SERVICES
AppTec's expert scientific staff is available for client consultations in such areas as sterilization validations, biocompatibility, viral clearance, environmental monitoring, quality systems, and regulatory testing requirements. Contact your Account Manager for more information regarding rates and availability.

TEST RESULTS REPORTING
Test results reports include detailed sample description, reference to a protocol or procedure, calculation methods when applicable, and conclusion when applicable. Unexpected test results are reported promptly to the client by telephone. Test results may be faxed free of charge, to be followed by a shipment of original test reports. In the interest of accuracy and to avoid miscommunication, we advise clients to rely on written reports for routine testing rather than requesting results by phone.

RECORD RETENTION
Copies of test reports are retained in a secure archive managed by AppTec’s Quality Assurance department.

AMENDED OR RE-ISSUED REPORTS
If, at the client's request, a test report is amended and a new report is issued, or if the client requests that AppTec re-issue a report, additional fees will apply. 

SAMPLE RETENTION & RETURN
Samples are discarded following completion of testing unless their return is requested by the client on the test request form. Return shipments entail additional fees that may vary depending on size/weight and quantity of samples and whether they are hazardous.
NOTE: Clients should be mindful of FDA and EPA GLP regulations regarding retention of samples. Retention of samples to meet these regulations is the responsibility of the test sponsor.

AUDITS
We welcome the opportunity for clients to see first hand our scientific expertise and laboratory capabilities. Audits of any of our facilities may be arranged by contacting your Account Manager or the Quality Assurance Manager at the appropriate facility.

PRICING / MINIMUM FEES
Clients should contact their Account Manager regarding all pricing information. 
Most tests entail a minimum fee of $50. Contact your Account Manager for more information.
Custom protocol development may require an additional fee. Payment of this fee will be credited to the final invoice if the study is performed within one year.

PURCHASE ORDERS / BILLING
Submitted samples should be accompanied by a purchase order (P.O.) number. 
For convenience, clients are invited to establish a "blanket" or "standing" purchase order to cover a specific period of time or a designated series of tests.
Testing projects of unusual length or complexity may require initial, partial and/or interim payment.
Credit applications may be required of new clients and AppTec may require new clients to make a payment in advance of test initiation.
Invoices are billed and payable in U.S. dollars only. Payment for all invoices is net 30 days. AppTec accepts payment by check (drawn on a U.S. bank), wire transfer, and Visa or Master Card credit cards.

CONFIDENTIALITY
AppTec’s entire staff is sensitive to our clients’ need for confidentiality regarding products, testing, and laboratory reports and data. All such information is held in strictest confidence and will be released only to persons or agencies authorized in writing by the client. Our submission of final reports is also considered to be in confidence, and clients may make no reference to such reports or to AppTec in any form of marketing materials, advertisement or press release without written authorization. 
Confidentiality agreements, to be signed by the client and AppTec management, can be provided. Contact your Account Manager for more information.

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