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Dependable Microbiological Testing

When it comes to microbiological testing and chemistry testing, rely on Sure-BioChem Laboratories, LLC, in Camden, New Jersey, for accurate, dependable testing. Our testing service offers a wide array of testing for various microorganisms.

Testing Fluids

Microbial Testing
Our testing services for microbial look for the total aerobic microbial, total yeast, and total mold counts. We use both DNA sequencing and Maldi-Tof™ testing to identify microorganisms. The microorganisms we look for are:

  • Candida Albicans
  • Escherichia Coli
  • Pseudomonas Aeruginosa
  • Salmonella
  • Staphylococcus Aureus

Pyrogen and Bacterial Endotoxins Testing:

  • LAL Test (Gel Clot, Turbidimetric Technique)
  • Validation of Depyrogenation with Dry Heat
  • Validation/Test for Interfering Factors
  • Monocyte Activation Assay

Sterility Tests:

  • Direct Inoculation
  • Membrane Filtration
  • Method Suitability Test

Sterilization Process
After we do the sterility tests, we evaluate the application of the sterilization process of bio-indicators. These microbiological tests are necessary for performance qualifications of sterilization processes.

Environmental Monitoring
When it comes to keeping your cleanroom’s environment pure, we offer a number of monitoring and testing procedures. Some of the main services we offer are:

  • Identification of Microorganisms
  • Microbial Count of Air
  • Microbial Count of Surfaces and Personnel
  • Particle Count
  • Sampling

Examination of Water Samples:

  • Bacterial Endotoxins
  • Identification of Isolates
  • Total Viable Aerobic Count

Efficacy of Antimicrobial Preservation Testing
For this, we test a microbial assay of antibiotics, using both diffusion and turbidimetric methods. These processes test for growth inhibition on an agar plate or in media (determination of MIC). All these tests are standardized or tailor-made, depending on your choice.

All of these tests and their variations are done according to EPA and USP standards for parenteral, ophthalmic, topical, and oral preparations. This way ensures the safety of your cleanroom and of your employees.

General Analytical Tests
Conductivity – Quantifies electrical strength and/or ion-facilitated electron flow in water; can also be used as an index for dissolved inorganic particulates. Monitoring the efficiency of water purification systems is key due to the fact that it must meet USP standards for purified water.
USP standards include Purified Water, Sterile Purified Water, Pure Steam, Water for Injection, Sterile Water for Injection, Sterile Water for Inhalation, Sterile Water for Irrigation and Water for Hemodialysis, as well as EP standards of Purified Water in Bulk.

pH – Determines how acidic or basic a solution is on a scale of 0 to 14. The results are important in assessing quality control.

UV/VIS – Calibrates how much ultraviolet-visible light is absorbed by translucent materials and solutions. This test complies with USP <851>, Spectroscopy and Light Scattering.

Materials Characterization

FTIR - Distinguishes and documents known color spectra, which can later be used as references or comparisons for upcoming samples that may or may not be known. Materials that can be tested vary from include lubricants, organic materials, and etc.

Testing is performed according to criteria outlined in the USP General Chapter 32 and the National Formulary 27, 2009, Chapter 851 on Spectrophotometry and Light Scattering and Chapter 198 on Spectrophotometric Identification tests.

Bacterial Endotoxin Testing – Analysis of identifying and measuring the amount of bacterial endotoxins. Ideally this test is used for medical devices or products that interact with different body systems. Periodic observations of different water systems and materials help to reduce the chance of endotoxins in final products.

Contact us to hire our dedicated team for all your microbiological testing and chemical testing services.

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