Science and labs
Microbiology studies
We test how products deal with germs. We check that preservatives, disinfectants and antibacterial surfaces work. We also check that sterile products are free of microbes, and we count the microbes in products that are not sterile.
What it is
In one sentence
We run lab tests that show whether a product kills germs, stops them growing, or is free of them, to the standard your market asks for.
Who it is for
Quality and regulatory heads at pharma, medical device, cosmetic, FMCG and packaging companies. Also makers of disinfectants and antibacterial materials. We test oral solids and liquids, injectables, creams and other topicals, cosmetics, medical devices, packaging and hospital surfaces.
Problems it solves
What goes wrong, and how we prevent it
A preservative test fails late
A preservative test takes about a month to run. If it fails just before launch, the launch waits. We suggest running it early, on a development batch, so there is time to change the formula.
The product hides the germs
Some products stop germs growing inside the test itself. Then a test can pass when it should not. Before each test, we check that our method can still find germs in your product. This is called a method suitability check.
The wrong standard for the market
The US, Europe and India each name their own pharmacopoeia (the official book of quality standards for medicines). A test run to one may not satisfy another. We agree the standard for each market before testing starts.
What you get
Deliverables
- Preservative efficacy test (PET) to USP <51>, EP 5.1.3 or IP. We add germs to your product and check the preservative kills them over 28 days.
- Sterility test to USP <71>. We check that a product sold as sterile has no living microbes in it.
- Bioburden and microbial limit tests to USP <61> and <62>. We count the microbes in a product, and check for specific harmful ones.
- Antibacterial and antifungal activity tests to ISO 22196, JIS Z 2801 and AATCC 100. We check that a treated surface or fabric kills germs or stops them growing.
- Endotoxin test by the LAL method. We check for endotoxins: toxic bits of bacteria that can cause fever if they get into the blood.
- MIC and MBC tests. We find the smallest amount of a substance that stops germs growing, and the smallest amount that kills them.
- Disinfectant efficacy tests to EN 1276, EN 13697 and AOAC methods. We check that a disinfectant kills germs in a liquid and on hard surfaces.
- Tests run with reference strains (known, traceable germs) from ATCC, NCTC and MTCC culture banks
- A test report for each study, reviewed by quality assurance before it is issued
How it works
From sample to report
A preservative efficacy test typically takes 6 to 8 weeks. This includes the 28-day test and the reviewed report.
Agree the test
You tell us about the product and the markets you sell in. We agree the test, the standard and the germs to use.
Send your samples
We tell you how many samples to send and how to pack them. We log each sample when it arrives.
Check the method
We check that our method can find germs in your product. If your product hides them, we adjust the method first.
Run the test
We run the test to the agreed standard, using traceable reference strains.
Review and report
Quality assurance reviews the results. You get a report that names the standard, the method and the outcome.
Regulators and standards
Standards we test to
We name the standard in every report. USP is the US Pharmacopeia, EP is the European Pharmacopoeia, and IP is the Indian Pharmacopoeia.
- USP <51>, EP 5.1.3 and IP
- Preservative efficacy. Does the preservative keep the product safe from germs during use?
- USP <71>
- Sterility. Is a sterile product truly free of living microbes?
- USP <61> and <62>
- Microbial limits for products that are not sterile. How many microbes are there, and are any harmful ones present?
- ISO 22196 and JIS Z 2801
- Antibacterial activity on plastics and other hard, non-porous surfaces. JIS Z 2801 is the Japanese standard that ISO 22196 is based on.
- AATCC 100
- Antibacterial finishes on fabrics and other textiles.
- EN 1276, EN 13697 and AOAC methods
- Disinfectants. EN 1276 tests a disinfectant in a liquid. EN 13697 tests it on a hard surface. AOAC methods are used for US claims.
- Terms explained
- Bioburden is the number of living microbes on or in a product. LAL (Limulus amebocyte lysate) is a test that uses an extract from horseshoe crab blood to detect endotoxin. MIC is the minimum inhibitory concentration. MBC is the minimum bactericidal concentration. ATCC, NCTC and MTCC are national collections of reference germs in the US, the UK and India.
Proof
Proof
We test for pharma, food and medical device companies. We also run microbiology tests for hospitals.
FAQs
Questions we are often asked
What is a preservative efficacy test?
It shows whether the preservative in a product keeps germs down during normal use. We add a set number of known germs to the product. Then we count how many survive at set times over 28 days. The standard says how far the count must fall to pass. It is also called a PET, or an antimicrobial effectiveness test.
How long does a preservative efficacy test take?
Typically 6 to 8 weeks. That includes the 28-day test itself and a report reviewed by quality assurance. Start early, so a failed result does not hold up your launch.
What is the difference between a sterility test and a bioburden test?
A sterility test is for products sold as sterile, such as injections. It checks that there are no living microbes at all. A bioburden test counts how many microbes are present. It is used for products that are not sterile, and before a product is sterilised.
Which test do we need to claim a surface is antibacterial?
For plastics and other hard surfaces, ISO 22196 or JIS Z 2801. For fabrics, AATCC 100. Each test compares a treated sample with an untreated one. The result shows how much the treatment cuts the number of bacteria. Your claim should match what the test measured.
Which tests support a disinfectant claim?
EN 1276 tests a disinfectant against bacteria in a liquid. EN 13697 tests it on a hard surface, which is closer to real use. AOAC methods are used for claims in the US. The right test depends on where you sell and what the label will say.
Who needs an endotoxin test?
Makers of injectable medicines and of medical devices that touch the blood or the spinal fluid. Endotoxins can cause fever even when the bacteria they came from are dead. So a product can be sterile and still contain endotoxin.
Do you keep reference strains?
Yes. We keep working stocks of reference strains from the ATCC, NCTC and MTCC collections. We record how many times each strain has been grown on (its passage history). We check the strains at set intervals.
Which products can you test?
Oral solids and liquids, injectables, creams and other topicals, cosmetics, medical devices, packaging and hospital surfaces. If your product is not on this list, ask us.
What if our product stops the test germs from growing?
This is common with preserved products and antibiotics. It can make a test pass when it should not. Before each test, we check that our method still finds germs in your product. If it does not, we dilute or neutralise the product (stop its germ-killing effect) and check again.
These answers are general information, not advice for your product. Rules change. Check the latest guidance, or ask our team about your product.
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Start a conversation
Talk to our microbiology team.
Tell us about your product and where you sell it. We will suggest the tests and standards you need.