Microbiology

Gibraltar Labs Microbiology Services:

Bioburden Testing | Depyrogenation Services | Endotoxin Testing | Sterility Testing | Rapid Sterility Testing | ST79 Testing | Mycoplasma Testing | Environmental Monitoring Testing

We are ISO certified for GLP and GMP studies.

Gibraltar Laboratories offers standard microbiological tests such as sterility USP <71>, bioburden, antimicrobial efficacy USP <51>, bacterial endotoxin USP <85>, Microbial Limits USP <61/62> and USP<2021/2022>, USP Cytotoxicity <87>, antibiotic assays USP <81>, mycoplasma and CCIT

  • 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
  • ST79
  • Microbial Identifications
  • Purified Water Validations
  • USP <81> Antibiotic Studies by cylinder plate (i.e., Bacitracin, Polymyxin, Neomycin, etc.)
  • EPA Chemical Germicides
  • Specialized Research Studies

Gibraltar tests for multiple industries

Services we provide for each industry include:

  • Medical Devices
  • Bioburden and Sterility testing per AAMI/ANSI/ISO Guidelines.

Gibraltar can conduct the recovery validation for calculation of efficiency factor and suitability of the sterility method (previously known as a B&F). Methods of testing are direct immersion and fluid path depending on the label claim of the product.

  • Endotoxin per USP <85> and AAMI/ANSI/ISO Guidelines.

Gibraltar routinely performs gel-clot and kinetic-chromogenic methods and validates the methods using inhibition/enhancement.

  • Cytotoxicity Testing per USP or ISO Guidelines.

Gibraltar can perform cytotoxicity testing using elution or agar diffusion methodologies.

Package integrity testing

Gibraltar can conduct many package integrity tests including

  • Bubble Emission
  • Methylene Blue Dye
  • Microbial Aerosol Challenge
  • Burst and Dust Drum Method
  • Container Closure Integrity Test (CCIT)

We also help develop sterilization protocols and perform necessary follow-up bioburden testing.

We support International standards such as  ISO 9000, ECN, BP, EP, ISO, OECD and JP. We also have a full range of storage and acceleration chambers available.

Disinfectants and sanitizers

These are tested for efficacy against a wide variety of bacteria, yeasts, molds and viruses as per EPA OPPTS guidelines. Registration of new efficacy claims against microbial pathogens, environmental contaminants as well emerging organisms.

  • BSL-2 and BSL-3 Laboratories

Stability for expiration dating

As part of expiration dating, samples are placed at real time and accelerated conditions. At designated time intervals, samples are removed for conducting stability indicating tests such as sterility and package integrity for medical devices and potency for pharmaceutical drugs.

Diverse pharmaceuticals

Gibraltar can conduct multi-compendial testing of raw materials and finished products for microbiology, analytical chemistry and molecular virology.

  • USP Microbial Limits
  • USP Antimicrobial Effectiveness Testing
  • Sterility/Suitability of the Method
  • Endotoxin
  • USP Purified Water
  • Environmental Monitoring

Tissue issues

Gibraltar performs:

  • Bioburden and sterility testing of incoming and in-process donor tissue samples
  • Microbial identification of the isolates to rule out pathogens
  • Reprocessing of reusable items used in the donor recovery process
  • Residue studies for chemical and antibiotics used in processing
  • Viral burden analysis by PCR of HIV, HSV, HBV, HPV, etc.

Contact us today!

To learn more, please call us at (973)-227-6882 or submit a contract form by clicking here.