Director - Quality DPT
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:
Testing raw materials is extremely important since these components will eventually end up in finished products.
When receiving raw materials, Gibraltar Laboratories, Inc. performs vender qualification in order to approve suppliers.
In many case three lots are tested once per year to verify that the Certificate of Analysis (COA) provided by the vendor is correct. It is important that our sponsor qualify more than one supplier to provide redundancy and business continuity. Then thoughout the year each lot is tested to verify the USP Identification requirement.
It is essential to revisit and review the current monograph for changes as revisions are often published, approximately every four months, varying between compendia.
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.
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.
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.
As the Pharmaceutical, Biopharmaceutical and Medical Device Industries add new technologies to the marketplace, it is vital that calibration programs are integral to the method development and validation testing used to ensure regulatory compliance and to ensure that the finished products be of the highest caliber.
Regulators take particular care to make certain that the methods and processes used in the industry are reproducible and validated to assure safety and consistency.
Virology/Molecular Biology is a rapidly expanding scientific arena, where the impact of virus, adventitious agents and DNA/RNA analysis broadens our horizons and exemplifies how the science of microbiology is utilizing rapid methods such qPCR.
Gibraltar Laboratories has taken a leadership role in Virology and Molecular Biology for a wide variety of industries.