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:
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.
Gibraltar helps companies with protocol development and validation testing for both microbiological validations and chemical validations
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.
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 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.
At Gibraltar Sterilization Services, we develop and validate our sterilization services on case by case basis to usually achieve a probability of a non-sterile unit of 10-6 [SAL]. We specialize in sterilization or autoclaving of heat labile molecules using air over pressure steam sterilization, manufacturing equipment used in aseptic processing, glass ware [vials, flasks, etc.] instruments, surgical tools, medical devices and medical equipment. Our methods for sterilization include: moist heat steam sterilization, dry heat sterilization, and liquid chemical sterilization. Custom kits including vials, seals and stoppers, cleaned depyrogenated and sterilized are available. Rapid reprocessing of orthopedic returns is also available.