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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. Applicable standard USP 645.

pH - Determines how acidic or basic a solution is on a scale of 0 to 14. The results are important in assessing quality control. Applicable standard USP 791.

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 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. Applicable standard USP 851.

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.

All testing meets the requirements outlined in USP chapter <85>, USP chapter <161>, ANSI/AAMI ST72:2011, EP 2.6.14 and the FDA Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers.

Microbiological Analysis - Microbial Identification - Identification of different microbial contaminants in products or the environment.Antimicrobial Preservative Efficacy Testing - Determines the validity antimicrobial preservatives used in different aspects as well as preventing growth of microbial contaminants in different products that could potential be used on the body.

Bioburden - Measures amount of microbial organisms found on different medical products, and can serve as an indicator for potential contaminants that can cause production issues.

Facility and Process Validation - Environmental Monitoring - Measure and observe various microbial organisms via different surface and air samplers, necessity of Good Manufacturing Practices. USP <1116>.

Water Testing - Assessment of microorganism and chemical contaminates to maintain water purity as a part of Good Manufacturing Practices. Various types of water can be tested like deionized, processed, and purified. Applicable standards include USP 1231, Standard Methods for the Examination of Water and Wastewater, GMPs.

Disinfection Process Validation - Confirms the effectiveness of different disinfectants used against various microorganisms. This test is important in terms of placing new disinfectant products on the market and for using in controlled areas. This test is not just subjected to industrial disinfectants and fungicides.

AOAC Chapter 6 tests, ASTM E 2315, USP General Chapter 1072 and ASTM E 26140.  We are highly experienced in performing general disinfectant efficacy tests to establish kinetic kill curves for a large variety or organisms.

Product Validation and Lot Release Testing -
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.

All testing meets the requirements outlined in USP chapter <85>, USP chapter <161>, ANSI/AAMI ST72:2011, EP 2.6.14 and the FDA Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers.

Bioburden - Measures amount of microbial organisms found on different medical products, and can serve as an indicator for potential contaminants that can cause production issues.

This test in accordance with ANSI/AAMI/ISO 11737-1 and is most commonly referenced in the Radiation Sterilization standards (ANSI/AAMI/ISO 11137-1 & 2) and the EO Sterilization standard (ANSIAAMI/ISO 11135).

Antimicrobial Testing -

Disinfectant Testing - Confirms the effectiveness of different disinfectants used against various microorganisms. This test is important in terms of placing new disinfectant products on the market and for using in controlled areas. This test is not just subjected to industrial disinfectants and fungicides.

Environmental and Evaluation of Water Systems - Assesses and confirms purified water requirements are met. This process involves testing for various chemicals and BET levels.Testing meets the USP water monograph and is performed on water and bulk water. Applicable standard includes USP 645.

The USP Water for Injection test validates water which has been purified by distillation, or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms.