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Quality Testing

Get to know our quality control testing

We follow rigorous testing and documentation procedures that go beyond industry standards to ensure you get reproducible results. Our industry-trained experts can also help design a custom testing program to meet your specific requirements.

See our standard assays Custom testing

INTRODUCTION

 

Quality you can count on

 

Our standard process includes 20 quality control assays that we perform on our raw materials

and finished products. We maintain retention samples for the lifespan of each product so we can test its integrity

at any time, and we can also perform custom stability testing for your unique storage conditions.

Tailored testing by product type

Explore the standard assays we perform on our raw materials and finished products, or talk to our team about our custom testing options.

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We go beyond industry testing standards to ensure we are working with high-quality raw materials that will meet your requirements. We can also help source and test specialized raw materials, and customize testing for your products to help you meet specific requirements. Learn more.

Incoming raw materials that will be used in the manufacturing of GMP-grade products undergo purity testing when applicable. Our purity assays meet USP <541> and USP <621> standards and include titrations and High-Performance Liquid Chromatography (HPLC). Titrations are used to determine the concentration of a specific substance in a solution, and HPLC is used to separate and quantify compounds in a solution, ensuring product consistency, evaluating stability, and detecting impurities.

Incoming raw materials that will be used in the manufacturing of GMP-grade products undergo identification testing when applicable. Our identification assays meet USP <197> and USP <191> standards and include chemical tests and Fourier Transform Infrared Spectroscopy (FTIR), which uses infrared light to scan test samples and identify organic, polymeric, and inorganic materials.

Incoming raw materials that will be used in the manufacturing of endotoxin-tested products undergo initial endotoxin screening. Our standard endotoxin limit is 1 M at <0.5 EU/mL, and lower specifications can be evaluated if needed to meet your requirements.

Our endotoxin assays comply with USP <85> standards. Endotoxins are lipopolysaccharide (LPS) molecules, a bacterial toxin found within the outer membrane of gram-negative bacteria. Testing for endotoxins is critical as their presence outside bacteria can trigger immune responses in cells and impact cell function and viability. We use the Limulus Amebocyte Lysate (LAL) assay to detect endotoxins in samples, where coagulation of LAL is observed in response to the presence of endotoxins.

Raw materials that will be used in the manufacturing of microbial culture media and agar plates undergo performance testing to ensure consistent growth across products and lots. They are inoculated with test organisms and assessed for growth using optical density, DNA concentration, and protein expression using sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) measurements.

We have refined our agar products and testing to make sure you get optimal performance and shelf life when they get to your lab. Incoming raw materials are screened for growth performance before being implemented on the floor, and final formulations are tested for consistency so you get reliable results from the first plate to the last in every batch.

We have developed a breadth of assays for our customers' unique applications, including handpicking 27 bacterial and 8 fungal strains to establish proprietary predictive growth patterns that allow us to assess plates across a wide variety of antibiotic combinations and concentrations. We perform growth assessments on every lot, including both the first and last plate within the lot, to ensure consistency.

We screen the first and last plates in every lot for sterility and performance to help ensure batch-to-batch consistency. Depending on the plate type, 1-day, 2-day, or 5-day incubation periods are used to confirm the medium is free from contaminants.

With our ISO 13485:2016 certified facilities, we can help make sure your products meet your regulatory requirements from RUO to GMP. Our rigorous quality control and functional performance testing ensures batch-to-batch consistency, and in some cases, we can also perform custom quality testing using your choice of microorganism.

Selective

This critical assay ensures accurate selective bacterial growth for a particular culture media by determining how broths either inhibit or allow the growth of desired microorganisms. Multiple strains are inoculated into the media and assessed after a growth period of 18 hours against a previously established growth pattern for the specific media and microorganism.

Non-selective

This critical assay ensures that a broth can support the growth of a wide range of microorganisms rather than inhibiting it. The media is inoculated with multiple microorganisms, and their growth is then quantified and compared to a previously established growth pattern for the specific media and organism.

Testing for accurate pH ranges in microbial culture media is critical as different microorganisms have specific pH requirements for growth. To confirm that pH values are within your desired range and are consistent from batch to batch, our quality control laboratory tests every lot to USP <791> standards. By request, we can measure variability to within +/- 0.04.

 

To correctly measure pH value, we carefully establish thermal equilibrium within a controlled environment where we allow the product to reach a uniform temperature of 25°C. Once the sample temperature has stabilized at 25°C, we measure the pH to confirm the accuracy and reliability of our production processes.

Our conductivity assays meet USP <644> standards. We measure the number of ions to monitor for deviations from predetermined values. This ensures there are no variations in conductivity that could impact the solution’s stability and be indicative of impurities.

Top spread

Our standard 2-day top spread assay ensures that products are free of microorganisms that may interfere with their efficacy. Finished product samples are plated onto two types of agar, Tryptic Soy Agar (TSA) and Sabouraud Dextrose Agar (SDA), and incubated for 2 days at 37°C and 28°C, respectively. 

Microbial enumeration

Our 5-day microbial enumeration sterility assay meets USP <61> standards. It is performed using a bioburden test that can detect any possible microbial activity to ensure that a product has not been contaminated in the manufacturing process.

 

A finished product sample is passed through a membrane that is then aseptically transferred to two types of agar, Tryptic Soy Agar (TSA) and Sabouraud Dextrose Agar (SDA). TSA plates are incubated at 30°C-35°C and assessed for growth after 3-5 days, and SDA plates are incubated at 20°C-25°C and assessed for growth after 5-7 days. Any plate containing non-zero CFUs does not pass. Both positive and negative controls are run alongside the test samples to ensure the validity of the test method.

Compendial sterility

Our 14-day compendial sterility assay is designed to identify microorganisms that may interfere with a product's efficacy. The 14-day incubation time is long enough to detect microorganisms that are slower-growing and may not be detected through shorter incubations.

 

A finished product sample is passed through a membrane that is then aseptically transferred to bottles containing either Tryptic Soy Broth (TSB) or Fluid Thioglycollate Medium (FTM). TSB bottles are incubated at 20°C-25°C for 14 days, and FTM bottles are incubated both aerobically and anaerobically at 30°C-35°C for 14 days. Turbidity is assessed after the incubation period.

We offer an extensive suite of fully customizable quality control testing for our buffers and reagents. Standard assays for RUO buffers and reagents include pH, conductivity, osmolality, density, and top spread sterility. To meet the requirements for your finished good specifications, we can also perform custom assays including endotoxin, DNase, RNase, protease, PCR, microbial enumeration, and compendial sterility testing.

For every lot of our buffers and reagents, our quality control laboratory uses a testing procedure that meets USP <791> standards to confirm that pH values are within your desired range and are consistent from batch to batch. By request, we can measure variability to within +/- 0.04.

 

To correctly measure pH value, we carefully establish thermal equilibrium within a controlled environment where we allow the product to reach a uniform temperature of 25°C. Once the sample temperature has stabilized at 25°C, we measure the pH to confirm the accuracy and reliability of our production processes.

Our conductivity assay meets USP <644> standards. We measure the number of ions to monitor for deviations from predetermined values. This ensures there are no variations in conductivity that could impact the solution’s stability and be indicative of impurities.

Our osmolality assay meets USP <785> standards. Osmolality is a variation of molality that accounts only for solutes that contribute to osmotic pressure. This parameter is important to monitor, as an incorrect osmolality can have detrimental effects on cells and tissues. It is measured in osmoles of the solute per kilogram of water.

Our density assay complies with USP <841> standards. Density is the mass of a substance per unit of volume and is measured using a densitometer. This measurement provides information about the physical properties and composition of the product to ensure its consistency and quality.

Our DNase, RNase, and protease assays ensure the absence of enzymes that can degrade DNA, RNA, and proteins. We use both fluorescence and absorbance-based assays to test for the absence of these enzymes in select reagents. In a fluorescence assay, nucleic acid and protein substrates are fluorescently labeled, and their signal is then measured. The presence of these enzymes will lead to an increased signal. Similarly, in an absorbance assay, changes in light absorbance at specific wavelengths demonstrate enzyme activity.

Our endotoxin testing complies with USP <85> standards. Endotoxins are lipopolysaccharide (LPS) molecules, a bacterial toxin found within the outer membrane of gram-negative bacteria. Testing for endotoxins is critical as their presence outside bacteria can trigger immune responses in cells and impact cell function and viability. We use the Limulus Amebocyte Lysate (LAL) assay to detect endotoxins in samples, where coagulation of LAL is observed in response to the presence of endotoxins.

 

Our standard endotoxin limit is 1 M at <0.5 EU/mL, and lower specifications can be evaluated if needed to meet your requirements.

PCR testing helps ensure the integrity of a product by reflecting the presence of specific bacterial DNA sequences in a sample. We use both traditional gel electrophoresis and microfluidic technology to amplify specific DNA regions through a series of controlled temperature changes in a thermocycler. This highly sensitive and targeted technique allows for quick analysis of small samples. To visualize and determine the size of the resulting DNA fragments, the amplified DNA is loaded onto either a traditional agarose gel or a microfluidic gel.

Top spread

Our standard 2-day top spread assay ensures that products are free of microorganisms that may interfere with their efficacy. Finished product samples are plated onto two types of agar, Tryptic Soy Agar (TSA) and Sabouraud Dextrose Agar (SDA), and incubated for 2 days at 37°C and 28°C, respectively. 

Microbial enumeration

Our 5-day microbial enumeration sterility assay meets USP <61> standards. It is performed using a bioburden test that can detect any possible microbial activity to ensure that a product has not been contaminated in the manufacturing process.

 

A finished product sample is passed through a membrane that is then aseptically transferred to two types of agar, Tryptic Soy Agar (TSA) and Sabouraud Dextrose Agar (SDA). TSA plates are incubated at 30°C-35°C and assessed for growth after 3-5 days, and SDA plates are incubated at 20°C-25°C and assessed for growth after 5-7 days. Any plate containing non-zero CFUs does not pass. Both positive and negative controls run alongside the test samples to ensure the validity of the test method.

Compendial sterility

Our 14-day compendial sterility assay is designed to identify microorganisms that may interfere with a product's efficacy. The 14-day incubation time is long enough to detect microorganisms that are slower-growing and may not be detected through shorter incubations.

 

A finished product sample is passed through a membrane that is then aseptically transferred to bottles containing either Tryptic Soy Broth (TSB) or Fluid Thioglycollate Medium (FTM). TSB bottles are incubated at 20°C-25°C for 14 days, and FTM bottles are incubated both aerobically and anaerobically at 30°C-35°C for 14 days. Turbidity is assessed after the incubation period.

The performance and consistency of our products start with the quality of our water system, which is why we use the same water we sell to our customers in our own manufacturing.

Our RODI water system

We use a continuously circulating RODI Water System that purifies water by ion exchange and a charged carbon adsorption column. The water undergoes reverse osmosis, UV treatment, and sterile filtration with a 0.1 micron filter.
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Rigorous monitoring and testing

 

Our water system is monitored in adherence to USP standards:

 

  • We continuously monitor online for conductivity and Total Organic Carbon (TOC) levels.
  • Our weekly tests for in-use water ports include endotoxin, bioburden, and TOC.
  • Our monthly testing includes RNase, DNAse, protease, mycoplasma, ammonium, calcium, magnesium, sulfates, chlorides, osmolality, nitrates, and particulates.

 

Each finished water product also undergoes its own quality control testing, and we can customize assays to include conductivity, density, DNase, endotoxin, osmolality, PCR, pH, protease, RNase, sterility, and TOC. 

Our WFI Quality Water

Our WFI Quality Water is a high-grade water that meets both EP and USP grade specifications and is 0.1 µm sterile filtered at the time of fill. It is ideal for producing cell culture media, reconstitution of biochemical reagents, or as a final-rinse water for critical applications.

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We can test to your specifications

Our team of experts can design and perform a custom quality control testing program to meet your specific requirements, including custom documentation and labeling.

We can also develop a tailored stability study to assign, or extend, a shelf life for your custom product or specialized raw materials. From off-the-shelf to fully custom and GMP-grade, we’re here to help you get the data you need.

Get in touch to learn more