Dr. Daniel Prince is president of Gibraltar Laboratories Inc. He has led the Company’s expansion and growth since 1987. Gibraltar Laboratories Inc. was founded in 1970 by Dr. Herbert Prince, co-discoverer of a cure for Hodgkin's disease (Procarbazine) and also involved with the team that developed the drug BACTRIM (TMP-Sulfa) now used extensively in the treatment of MRSA infections, Gibraltar Laboratories, Inc. (GBL) has over 39 years of exemplary service to its credit.

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CORPORATE CAPABILITIES

TEST SERVICES

GBL's eminent scientific staff and stellar track record make it the gold standard of contract labs. It is was one of first and is still one of only a few labs in the country currently ISO 17025 certified. With labs in New Jersey and a staff of forty scientists (including Three PhD's, and five Masters-level Scientists), companies turn to GBL for the most exacting research, testing, and scientific consulting.

Gibraltar Laboratories' scientific standing and expertise make the company a most valuable resource-as both consultants and advocates-that a client can have in navigating the regulatory approval process. In case after case, GBL's work has earned the respect of both peers and policy-makers. Gibraltar also maintains key affiliations with professional bodies that help set the standards which may affect GBL's clients-ISO, USP, AAMI, ANSI, ASM, ASTM, AOAC, AATB, CSPA etc. Through these affiliations as well, GBL is able to keep clients apprised of pending regulatory issues as well as the latest trends in industry.

And Gibraltar's strict quality control means that a client's regulatory release test results can be defended even under the most exacting scrutiny. In over four years, for example, the data from GBL's fully traceable reporting and Upstream QA® systems have not resulted in a single "483" from the FDA, nor a revoked registration from the EPA. That's because Gibraltar doesn't just cite a monograph and leave the rest to the imagination, the way most labs do. From the time a client submits samples, Gibraltar's tracking systems report all there is to know about the test's status, process, and data. Every detail of the process is documented, so clients (and auditors) can confirm that testing was done in accordance with protocols.

Validations/Calibrations

Gibraltar helps companies with protocol development and validation testing for both microbiological validations and chemical validations

• Cleaning Validation
• Process Validation
• Method Development
• Method Validation
• Method Transfer
• Clean Room Air quality
• Trained Gibraltar staff can travel to your facility to perform Thermal Mapping of Refrigerators, Autoclaves, Freezers, Incubators etc.

Microbiology

ISO certified for GLP and GMP studies. Sterility, Bioburden, Preservative efficacy, Bacterial Endotoxin USP <85>, Microbial Limits USP <61, 2021> and other standard microbiological tests offered. GBL helps develop sterilization protocols and performs necessary follow-up bioburden testing. International standards supported include blue book, ISO 9000, ECN, BP, EP, ISO, OECD and JP. A full range of storages and acceleration chambers are available.

In addition, medical devices are tested for Reprocessing as per AAMI TIR 12, Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers. We also follow AAMI TIR 30:2003, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. Validation of sterilization by steam processes is accomplished with challenge strips of Geobacillus sterothermophilus. Disinfectants and sanitizers are tested for GLP effectiveness against a wide variety of bacteria, yeasts, molds and viruses as per EPA OPPTS/AOAC guidelines.

Biopharmaceuticals

Testing for adventitious agents as per 9 CFR 113, Growth Inhibition, USP <87> cytotoxicity [elution and agarose overlay] EPA virology efficacy experiments on a large number of animal and human viruses, Complement Activation, Thromboresistance, thrombin time, Red Blood cell hemolysis, Mycoplasma screening as per 21 CFR, Evaluation of vaccine/host systems for Hemagglutination, Inclusion Bodies, Mycoplasma, adventitious viruses.

Chemistry

ISO certified. GBL performs a wide range of chemistry studies, including, qualification of APIs and Raw Materials as per USP, EP, JP etc, ETO residuals, USP <467> Residual Solvents, FTIR, GC, HPLC, OVI, TOC, UV/Vis, and USP Dissolution, Specific Rotation, Ion Chromatography, Particulates, Hemoglobin and stability testing. GBL also assists with special projects/complaint resolutions (FDA, EPA, DOT). A full range of storage and acceleration chambers are available. To view some great images of various crystals such as urea, napthalene, methylene blue and enalapril please click here.

Environmental Monitoring

Environmental Monitoring can be performed by trained Gibraltar microbiologists to sample utilities in pharmaceutical plants including water, nitrogen, compressed air and other gases for particulate debris, hydrocarbons, airborne particulate matter viable non-viable and contaminating microorganisms. In addition, sampling of the air for viable and non-viable particulates is performed together with trend analysis. Microbial identification of the indigenous organisms is performed together with verification of the cleaning and disinfecting agents used to control the microorganism load in the facility. All testing as per USP <1116> MICROBIOLOGICAL EVALUATION OF CLEAN ROOMS AND OTHER CONTROLLED ENVIRONMENTS and ISO 14644.

Herbert Prince

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