- Microbiology: Testing Methods
- What kind of testing do we provide?
We provide testing for microbial enumeration, presence and absence of specified organisms, as well as detection for bacterial endotoxins (see below).
- What is microbial enumeration?
Microbial Enumeration is the quantification of bacteria and fungi that may grow under aerobic conditions, allowing us to identify which microorganism strain is present in a given sample and in what concentration. Microorganisms can include pathogens such as bacteria that can cause disease, as well as fungi.
- What is the test for specified organisms?
This test determines the presence and/or absence of specific organisms under aerobic or anaerobic conditions.
- What types of microbial enumeration and tests for specified organisms do we perform?
The types of microbial pathogens we are able to identify for samples are listed below. The USP chapter listed contains the regulations we follow in our testing should you need your testing validated.
USP Chapter Test <61><62> Suitability Testing
• Suitability of the Counting Methods in the Presence of Product
• Suitability of the Test Methods in the Presence of Product
<2021><2022> Preparatory Testing <51> Antimicrobial Effectiveness Testing <61> Microbial Enumeration Testing
• Total Aerobic Microbial Count
• Total Yeasts and Molds Count
<62> Bile Tolerant Gram Negative Bacteria <62> Escherichia coli (E.coli) <62> Salmonella <62> Pseudomonas aeruginosa <62> Staphylococcus aureus <62> Clostridia <62> Candida albicans <85> Endotoxins <2021> Heterotrophic Plate Count on Process Water <2021> Total Yeasts and Molds Count <2021> Bile Tolerant Gram Negative Bacteria <2022> Escherichia coli (E.coli) <2022> Salmonella <2022> Pseudomonas aeruginosa <2022> Staphylococcus aureus <2022> Clostridia
In addition to USP methods, we offer the following microbiological testing:
Testing Method Test FDA/BAM and SM9221D Total and Fecal Coliforms In-House Method Burkholderia cepacia In-House Method Aspergillus brasiliensis
- What methods do you follow?
We follow follow USP <61> and <62> for pharmaceutical samples, and USP <2021> and <2022> for dietary supplements. Additionally, we have in-house methods for cosmetics samples, water samples, and we also follow FDA/BAM as needed.
- Suitability Testing
- What is suitability testing, and why is it significant?
Suitability testing is an integral part of any microbiological test system. It allows us to determine the appropriate diluent/dilution factors/enrichment media required to neutralize any inherent antimicrobial properties of drug products and ingredients (tested according to USP chapters <51>, <61> and <62>) when sample preparations are challenged with specific, viable test microorganisms.
We perform two types of suitability testing. One tests for the suitability of the counting methods in the presence of a product, and is governed by USP <61>. The other tests for the suitability of the test methods in the presence of a product and is governed by USP <62>. In either case, select test organisms are spiked into the product and cultured. The sample passes if a certain percentage of the organisms are recovered, proving the culture method suitable for the product.
- When and how often is this test administered?
Suitability testing is the first test performed on new samples. As long as the formula of a finished product is not changed, this test need only be administered once.
We note that some of our clients request that we run several tests concurrently, including suitability testing, but we recommend that suitability testing be performed prior to any other tests. Should suitability testing fail for your product, then the results of any concurrent tests would be invalidated and unusable.
- How long is the data maintained for?
5 years from the date of Certificate of Analysis being issued to client.
- What methods do you follow for suitability testing?
We follow USP <51>, <61> and <62> for all suitability testing. Our FDA-regulated laboratory meets strict CGMP requirements, including rigorous documentation and quality assurance for all testing performed.
- Do I need to get suitability testing for my sample?
We highly recommend suitability testing for all products, especially when products are being submitted to the FDA for approval. CGMP regulations, which are enforced by the FDA, require that methods are suitable for a given product. The FDA will require evidence that the tests given are valid for a given product with a recorded demonstration of validity.
In the absence of suitability testing, we would perform generic testing methods on your sample, but we would not be able to verify that the testing methods were valid for your sample. Consequently, there is a probability of obtaining false results. For example, if a sample contains antimicrobial properties, but those properties are not discovered during suitability testing and the sample is subjected to generic testing methods without accounting for or neutralizing antimicrobial properties, it is highly probable that any contamination in the sample will go undetected and result in a false negative.
Without suitability testing, the product will not withstand FDA scrutiny.
- How should I submit my samples?
Samples must be shipped to us in sterile containers. Contaminated containers could cause false positive results as our testing methods will detect contamination that does not necessarily originate from the sample itself. It is not possible to distinguish if a sample fails its testing specifications due to contaminated sample containers or faulty manufacturing process. In either case, the manufacturer may need to discard the contaminated stock and investigate their processes, which can result in loss of time and money. Therefore, it is in your best interest to carefully package your samples in sterile containers to prevent loss of time and product.
- What types of products have you performed suitability testing on?
We can run suitability tests on many products. Examples of products we have run suitability tests on include: nutriceuticals, pharmaceuticals, cosmetics, ointments, toothpaste, bandages, tofu, salad dressing, dairy, some medical devices, air strips, and air sampling.
- Preparatory Testing
What is Preparatory Testing?
Preparatory testing is similar to suitability testing and is used to determine the appropriate diluent/dilution factor, enrichment media required to neutralize any inherent antimicrobial properties of dietary supplements and food ingredients (tested according to USP chapters <2021> and <2022>) when sample preparations are challenged with specific, viable test microorganisms.
- Antimicrobial Effectiveness Testing
- What is antimicrobial effectiveness testing?
Antimicrobial effectiveness testing demonstrates the effectiveness of preservatives added to drug products when challenged with specific test microorganisms and monitored for 28 days. USP <51> is followed.
Antimicrobial preservatives are often added to pharmaceutical drugs that contain water as a solvent or medium in order to protect drugs from microbiological growth, or from microorganisms that may be introduced inadvertently during or after the manufacturing process. Alternatively, antimicrobial preservatives may be added to products that are packaged in multiple-dose containers that will be handled repeatedly by a consumer so that the growth of microorganisms are inhibited.
All useful antimicrobial agents are toxic substances. To protect consumers, the concentration of the preservative shown to be effective in the final packaged product should be below a level that may be toxic to human beings based on the recommended dosage of the medicinal product.
The concentration of an added antimicrobial preservative can be kept to a minimum if the active ingredients of a formulation are intrinsically antimicrobial. Antimicrobial effectiveness, whether inherent in the product or produced because of the addition of an antimicrobial preservative, must be demonstrated for all injections packaged in multiple-dose containers or for other products containing antimicrobial preservatives.
Antimicrobial effectiveness testing allows us to see how effectively the preservatives in a finished product kill off specified bacteria, called challenge organisms, during the time period that the product would be used by a consumer. Challenge organisms are generally based on likely contaminants to a drug product when considering the product’s physical attributes, formulation, and intended use.
- What products typically require antimicrobial effectiveness testing?
Any product containing preservatives having antimicrobial properties would be subject to antimicrobial effectiveness testing.
- What procedures do you follow for antimicrobial effectiveness testing?
We follow USP <51> for all antimicrobial effectiveness testing.
- How should I send my product and/or sample?
The procedures and acceptance criteria for effectiveness apply to a product in the original, sealed container in which it has been or will be distributed by the manufacturer. The test does not need to be conducted in these containers, but please be careful to avoid using materials that can interact with the preservative in the containers that are used for antimicrobial effectiveness testing.
All samples must be sent in sterile containers. Additional information on sample submissions can be found here: Sample Submissions
- Bacterial Endotoxins Testing
- What is Bacterial Endotoxins Testing?
Bacterial Endotoxins Testing (BET) detects or quantifies endotoxins from Gram-negative bacteria using amoebocyte lysate from the horseshoe crab.
- Why is Bacterial Endotoxins Testing important?
Presence of endotoxins in blood can cause fever, vomit, diarrhea, leading up to fatal septic shock.
- How does New Jersey Laboratories test for Bacterial Endotoxins?
We test for bacteria endotoxins by all three methods specified in the USP <85> – gel clot testing, turbidimetric testing, as well as chromogenic testing. Our analysts are trained in all three methods, giving clients the flexibility needed to obtain accurate results in a timely manner. Additionally, we perform limit and quantitative tests for bacterial endotoxins.
- What are the requirements for Bacterial Endotoxins Testing at NJ Labs?
Product validation is required before performing endotoxins testing. Endotoxin limit, as defined by regulatory agencies for your product, is also required to perform testing.
- What methods do we use for Bacterial Endotoxins Testing?
NJ Labs follows USP <85>, as well as the guidelines of ANSI/AAMI ST72:2011/(R)2016 as required by the FDA.
With over 80 years of experience in CGMP testing, our dedicated microbiology laboratory is on standby to meet your testing needs. We support your products' compliance with relevant regulatory requirements. If you are uncertain what tests are necessary, our staff of trained microbiologists are available for consultation and will guide you to ensure your products remain FDA-compliant.
When submitting samples, please submit your sample along with the sample submittal forms. In order to prevent delays in testing, please specify the relevant tests, USP chapters, and microbial specifications you require on the form.
Some of the microbiology testing services we provide are listed below. If you are interested in microbiology testing not listed, please reach out to us. We will work with you to reach a testing solution.