Gibraltar Laboratories provides microbiology and analytical chemistry services in stability and quality control to the pharmaceutical, medical device, biotech, nutraceutical, cosmetic, specialty chemical and tissue bank industries. Gibraltar Sterilization Services provides moist heat steam sterilization for medical devices and to support aseptic manufacturing. Our services and specializations include:

Analytical Chemistry

• Compendial Release Testing of Raw Material and Drug Products e.g. USP, EP, JP
• Forced Degradation and Stability Studies
• Development and Validation of Test Methods for Testing of Active Drug Substances and Dosage Forms
• Dissolution Test Method Validation
• Plan and Development of Analytical Cleaning
• Validation Studies
• Method Transfer
• Process Validation
• Residual Solvents/Volatile Organic Impurities USP <467>

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. Gibraltar Laboratories 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 storage 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.

• BSL-2 and BSL-3 Laboratories
• Cleaning Validation
• Bioburden and Sterilization Validation
• USP/EP Microbial Limits and Preservative Challenge
• Environmental Monitoring and Package Testing
• Antimicrobial Agents
• Endotoxins and in-vitro Toxicology
• ST-79
• Microbial Identifications
• Purified Water Validation
• USP Antibiotic Studies Bacitracin Polymyxin Neomycin
• EPA Chemical Germicides
• Specialized Research Studies

Virology

• 9 CFR 113
• Biopharmaceuticals (Adventitious Agents)
• Viral Content
• Formulation Efficacy Studies
• H1N1
• Antiviral Chemotherapy: Screening

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.

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, 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. 

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.

Sterilization Services

Gibraltar Labs also sells sterile media to companies for their media fills. A media fill is the process in which aseptic manufacturing is validated to be safe. First the manufacturing equipment needs to be cleaned and sterilized before it is used. As proof that cleaning and sterilization was effective, sterile culture media is plumbed through all the equipment. All of the media is then collected and tested for sterility. If any bacteria, yeast or molds were present, then the sterility test would detect them. If the tests are negative then the cleaning and validation steps were successfully validated. The manufacturing process can now be used for its intended healthcare purpose with a high probability of sterility expressed as a sterilization assurance level [SAL] of 10-3.