Click on any of the following to get more detailed information about that service.

All services are covered by the ISO registration.

Services for validation of re-usable devices are also available.

ISO Certified 13485:2003    ISO/IEC 17025:2005 Accredited

FDA Registered/GMP    EN554 Registered

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A wide variety of products flow through numerous semi-automated and manual manufacturing lines.

Products include: stainless steel and titanium implants, composite drug delivery systems, tubing sets, kits, catheter products, pharmaceutical manufacturing aids, surgical supplies and implantable micro-chips.

Packaging, labeling, bar coding, boxing and palletizing operations are established for most lines. Packaging includes pouches and trays for gamma, ethylene oxide and steam sterilized products. Upon client's request, Biotest Laboratories, Inc. will interface directly with the contract sterilizer. Small batch steam sterilization may be performed at Biotest Laboratories, Inc.

Cleaning and passivation lines are batch processes which may include the following rinses; alcohol, detergents, USP purified water, WFIr and/or specified HNO₃ concentrations.

Process validation is recommended for routine manufacturing. In particular, chemical bonding, packaging, cleaning, passivation and sterilization processes should be validated.

Biotest Laboratories staff members consult and frequently publish articles on a variety of subjects.  Since 2001, 15 articles have been published in the areas of sterilization, validation, process control, and controlled environments.

Types of Consulting Offered:

• Regulatory
• Validation (Process, Sterilization, Packaging)
• Manufacturing
• Laboratory Testing
• Cleanroom Testing
• FDA/510(k) Submissions and Responses

Gregg A. Mosley, Biotest Laboratories President, has more than 35 years of experience as a microbiologist, chemist, and biochemist.  He has served for the Association for the Advancement of Medical Instrumentation (AAMI) for over 25 years and was elected to the Board of Directors in 2004.  He is lead instructor for the Industrial Sterilization Course, and Co-chair of both the Biological Indicator Committee and Industrial Moist Heat Sterilization Committee of AAMI.

Gregg served on the editorial board for the international publication Journal of QUALITY ASSURANCE: Good Practice, Regulation and Law and currently serves in a similar capacity for the Institute of Environmental Science and Technology (IEST) Journal and Controlled Environments magazine.

Utilizing the application of Evariology, our consultants have the tools and knowledge to trend organism populations in your controlled environments over time and provide guidance for managing microorganisms throughout your facility. 

Testing includes: particle counts, leak testing, air flow measurements, air exchange calculations, manometer or magnehelic gauge calibrations, and microbiological testing.

A complete test plan protocol can be developed at the client's request. Reports list all raw data, room diagrams, HEPA's and returns, test points, procedures and equipment. Equipment is calibrated and NIST Traceable.

The in-house laboratory allows for faster cleanroom testing results.  Microbiology testing may include:

• Air samples
• Rodac plates
• Settle plates
• Swabs
• Organism identification (I.D.)
• Trending and data integration in the Managing Microbes program, applying the tools from Evariology

Current contract sterilization includes: medical devices, diagnostics, drug delivery systems and components. These include routine sterilization for product release, product compatibility studies, sterilization validation, verification studies that mimic hospital cycles for producers of non-sterile products and R & D test cycles.

Biotest Laboratories Inc. was developed primarily for medical product test requirements for microbiology, chemistry and bacterial endotoxins. Additional tests have been added. The "Laboratory Testing" list identifies routine analyses and test codes.

Testing Services Sheet

Price includes fax of report.
Products requiring manipulation such as extensive cutting, disassembly, or special handling will incur additional charges.

Specific test results may not be indicative of the characteristics of any other samples from the same lot or similar lots. Liability is limited to the cost of the tests.

Biotest Laboratories, Inc. provides "Test Request Forms" as part of the vendor/client contract. Disposition of products must be identified on this form. If "SAVE [ ]" is not marked, then following the completion of testing, Biotest Laboratories, Inc. will discard samples. We reserve the right to return all hazardous test samples to the client.

When requested, we will return remaining samples to the client. Additional fees may be incurred plus shipping expenses for the return of samples. Fees vary according to quantity and weight of samples and whether the sample is hazardous.

USP procedures for products listed in the USP and other clearly defined test methods (AOAC, ASTM, AAMI, ISO, etc.) are generally considered to be validated. Many other test procedures should be validated for the particular products being tested. It is the client's responsibility to insure that the validation status of test procedures used for products is approved by their internal quality system. The test fees listed in this schedule do not include the procedures validation costs.

Biotest Laboratories, Inc. offers services for validation of test procedures. Please call our department managers to discuss validation issues regarding the test procedures used for your products. The Biotest Laboratories, Inc. Validation Department has primary responsibility for process validation studies.

Biotest Laboratories, Inc. provides services to its clients on a fee-for-service basis. The only warranty provided is that Biotest Laboratories, Inc. will perform its services with due care in accordance with approved procedures or protocols and generally prevailing industry standards and applicable domestic or international standards and regulations. The only remedy for breach of the warranty will be to require Biotest Laboratories, Inc. to perform the same service over or to be credited for fees paid for the performance of the original test.

Specific test results may not be indicative of the characteristics of any other samples from the same lot or similar lots. Biotest Laboratories, Inc. assumes no responsibility for how a client chooses to use specific test results. Neither Biotest Laboratories, Inc. nor subsidiary companies shall be liable under any circumstances for any amounts in excess of the cost of the tests performed.