Development & Getting Started

To start selling products categorised as toiletries & cosmetics into the UK (EU) a product information file is required. This will include the following technical information:

For non-anhydrous products (containing water)

If you are having problems with an in-house contamination and cannot see that specific organism in our list of tests, please contact us and we can advise on what testing can help.

Number of tests and frequency of testing can be reviewed once satisfactory microbiological pedigree has been established.

We offer a wide range of tests that can be used for batch release and routine testing.

Key points of shelf-life testing

• Testing Regime  - setting out the different tests that will be conducted.

• Test schedule is set  - when the test regime is going to be performed. At a minimum it can consist of initial and final test points, however if the product fails along the way you will not know exactly at which point; it is therefore suggested to include some intermediate test points. Initial test point should be as close to the date of manufacturing as possible.

• Batch variability and representative sampling  -To make a comment suggesting a shelf life we would need to test two different batches, to account for differences between batches.Samples will need to be of sufficient size to make sure each part of a product is tested e.g., a pizza would need the crust, sauce and toppings tested.

Accelerated shelf life testing (higher temperatures) can be used for certain kinds of products. However, it is not always suitable for other kinds of samples. An accelerated shelf life test will need to be backed up with a real time study (20°C) as microorganisms do not always behave the same in accelerated tests.

Please contact us and we can give you suggested test regimes and schedules for your product and target shelf life.

It would be helpful if you could provide us with the following information about your product:

• What product you want testing

• Test regime (if known)

• Target shelf life

• Storage conditions

See Tests

Batch releases should be handled in a manner similar to cosmetics, although the products can generally be considered lower risk since they are typically not intended to directly contact the skin. They are often to be used with gloves as additional protection. It is particularly important to consider the presence of foodborne pathogens in kitchen products due to the high likelihood of cross-contamination. Consideration should be taken with spray products, as there is an increased risk of inhalation.

It should be noted that concentrated detergents and disinfectants may interfere with preservative systems and pose challenges for effective neutralisation. Extra validation and PET (preservative efficacy testing) may be required to ensure a robust formulation and comprehensive testing regime.

Chemical disinfectants and antiseptics

This step involves exposing the product to known levels of specified organisms for a specified contact time, followed by the assessment of log reduction. To achieve a 99.9% reduction, a 5 log reduction must be demonstrated. This evaluation can be conducted with or without the presence of interfering substances, which aid in simulating both clean and dirty conditions.

Most commonly used is the BS EN 1276 is a quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas – Test method and requirements (phase2/step1)

This involves 4 standard test organisms plus testing in the presence of high and low levels of organic soil. A hand sanitiser (hand rub or hand wash) needs to achieve a = 5 log reduction in the viability of each test organism within 60 seconds to pass the test. * A hard surface cleaner needs to achieve a = 5 log reduction in the viability of each test organism within 5 minutes to pass the test.

*Please note: a hand rub is tested neat, whereas a hand wash requires testing at 3 concentrations.

Based upon a BS EN 1276 test, you should be able to make the following claims:

• Kills 99.9% of harmful bacteria

• Conforms to BS EN 1276:2009

Target turnaround for BS EN 1276 is 4 weeks. It is very likely that the test will be completed within the turnaround, provided there are no problems with validation.

Prices given upon request -

• Handrub or surface cleaner (1 contact time)

• Handwash (3 contact times)

Sample size required = 150g.

See Test

Environmental monitoring is essential in manufacturing, aligning with GMP principles and ISO 22716 requirements. It ensures the control of environmental factors that can impact product quality and safety, assists in risk management, and demonstrates compliance with regulatory standards. By actively monitoring the manufacturing environment, manufacturers can proactively protect their products, enhance customer satisfaction, and uphold their commitment to quality and safety.

See Test

Swab Sampling

Stick swabs are utilised to assess contamination levels on various surfaces, including floors, walls, equipment, and hands. After collecting the swabs, please promptly send them to us using a cool pack for testing within 48 hours.

Air Sampling

For each designated test point, you will receive two air plates. These plates will be exposed for a duration of 1 hour, sealed, and returned to the laboratory. Our analysis will adhere to Class D pharmaceutical limits, specifically designed for non-sterile manufacturing processes.

TVC Bacteria, Yeast and Mould - Total Viable Count (TVC)

This is also known as aerobic colony count (ACC) and aerobic plate count (APC). The test looks for the number of viable aerobic mesophilic bacteria that can grow on Standard Methods Agar or Tryptic Soy Agar at 30°C within 3 days and yeast and moulds that grow on Sabouraud Dextrose Agar or Potato Dextrose Agar at 25°C within 5 days.

Viable aerobic mesophilic bacteria are living bacteria that grow between 25°C and 40°C in the presence of oxygen.

Detection or presence/absence of pathogens

This is where a specified amount of product is mixed into a broth that will grow the target organism. This suspension is then incubated to allow any contamination to multiply to many times its original number. After this step has been completed, the broth is streaked onto selective agar plates that will grow the pathogen in question.

CFU colony forming units

The counts are represented as CFU, not as a number or cells, because microorganisms do not spread or grow evenly throughout a product; they could be individual cells or clumps of cells. When these are plated they form individual colonies on an agar plate.

Scientific form/numbering

At DLL we use the format given in excel ‘e’ = ‘X10^’
+ means the decimal point moves to the right; – would mean it moves to the left.

1,000 = 1.0e+3
1,000,000 = 1.0e+6
23,000 = 2.3e+4

Limit of detection

This is the smallest or largest amount detectable for any given test.

For a TVC using a 1 in 10 dilution of the product would be <10cfu/g meaning counts below this threshold are not detectable with this method.