Gibraltar specializes in qualification of vendors that supply critical raw materials used to manufacture drugs and biotech products.

Gibraltar performs all testing as per CGMP and all raw data is reviewed by both the Chemistry department study director, analyst and independently by the Chemistry Quality Assurance Department.

Tests include melting point, heavy metals, Karl Fisher, TOC, Conductivity, residual solvents.

Gibraltar performs all compendia microbiology tests as well as many special projects intended to support FDA submissions of 510Ks, NDAs, INDs, and aNDAs.

Bioburden, sterility, microbial limits, and microbial identifications are performed on tissues, medical devices and ingredients.

Gibraltar is expert in official compendia such as AATCC, AATB, AOAC, ASTM, BP, EP, EPA FCC, FDA, ISO, JP, USP, QVC, USP.

The Molecular Biology department uses  PCR, ELISA, immunofluorescence, SDS-Page and Western Blot for the detection of pathogens (viruses, mycoplasma, bacteria and fungi), mycotoxin and allergens in contamination of food, nutritional supplements, raw materials, drugs and biologics. Cleaning Validations and establishment of Instructions for Use for reprocessing reusable medical devices by examining: protein, hemoglobin carbohydrates, endotoxin, total organic carbon and bioburden.  We provide expert solutions for special R&D projects like antiviral, anticancer and stem cells for pharmaceutical companies. Additional testing available such as: viral penetration, viral clearance, ISO/USP cytotoxicity, in-vitro eye/skin irritation, DNase/RNase, and protein/peptide analysis.

Gibraltar Sterilization Services is a leading provider of moist heat/steam sterilization services with special expertise supporting aseptic manufacturing and cleaning. Equipment used in the processing of biological materials can be quickly decontaminated, cleaned, sterilized and returned to your facility. Instrument trays are also validated as per FDA, AAMI/ANSI ST79 and ISO 13485. Cleaning validation, sterilization validation and sterilization release for surgical devices, pre-filled syringes and components is provided. Vials and components are cleaned prior to sterilization and rinsed with Water for Injection (WFI). For hospitals,Gibraltar Sterilization Services is available as a backup or alternative to Central Supply.