Sure-BioChem Laboratories, LLC (SBL) is a contract testing laboratory partnering with government, pharmaceutical, environmental, biotechnology medical device and food industries as an efficient outsourcing solution. The mission of SBL is to provide the highest quality microbiological and chemical analytical testing services by acting with high moral principle, adhering to the highest professional standards and maintaining the trust and confidence of all with whom we engage.
SBL works diligently to anticipate and adapt quickly to current challenges and new requirements by continuously assessing the environment in which we operate and devising solutions to better serve and contribute to scientific, human and physical resources that will ensure the Nation's capability to prevent disease, to improve the success of research, shorten the time of product development/manufacturing and help protect the global environment.
With extensive recalls being prominently featured in the news with growing frequency, customers are more mindful than ever of the dangers correlated with food product contamination.
As a result of the spike in food product safety concerns, in 2011, the FDA Food Safety Modernization Act (FSMA) was brought into law. These controls require that all segments of our food chain be painstakingly overseen, tried and evaluated.
Sure-BioChem Laboratories can help you with the compliance of all the parts of the FSMA. Tests include:
In addition to being your subject matter experts in FSMA compliance, our accomplished team of scientists hold fast to a strict nature of techniques and norms when testing the integrity of food products.
As per the Food and Drug Administration's Bacteriological Analytical Manual (FDA BAM), we test food products for different bacterial, viral, parasitic, yeast and microbial contaminants, including Listeria, E. coli, and Salmonella.
Environmental Monitoring - Measure and observe various microbial organisms via different surface and air samplers, necessity of Good Manufacturing Practices. USP <1116>.
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.
Our testing services for microorganisms look for total aerobic microbial, total yeast, and total mold counts. We use both DNA sequencing and Maldi-Tof™ testing to confirm microorganism identification. Some examples of microorganisms we can look for include:
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 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.
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.
This chemical test 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.
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.
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.
Antimicrobial Activity Testing Services
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SURE-BIOCHEM LABORATORIES LLC has not received any endorsements.