Total Viable Counts
Total viable aerobic counts performed to BP, EP, USP, JP etc for
- Bacteria (TAMC)
- Yeasts and moulds (TYMC)
We can also perform verification of neutralisation (method suitability) for the microbiological examination of products using procedures that meet the harmonized pharmacopoeias USP <61> and <62>; and Ph.Eur. 2.6.12 and 2.6.13.
BS EN 21149 Cosmetics microbiology – Enumeration and detection of aerobic mesophilic bacteria.
BS EN 16212 Cosmetics microbiology – Enumeration of yeast and mould
BS EN 22717 Cosmetics microbiology – Detection of Pseudomonas aeruginosa
BS EN 22718 Cosmetics microbiology – Detection of Staphylococcus aureus
BS EN 18416 Cosmetics microbiology – Detection of Candida albicans
Absence of Specified Organisms
Presence/Absence tests performed for most types of organisms from a variety of source materials Including food, water, consumer, household, cosmetics, toiletries and pharmaceutical medicinal products.
- E Coli
- P aeruginosa
- S aureus
- Listeria monocytogenes
Water Testing and Monitoring to a variety of standards or specifications using standard microbiological techniques.
BS 6068-4.18 and ISO 11731 For the detection and enumeration of Legionella pneumophila.
Pharmacopeal Methods or Client Specific Licensed Methods
For the microbiological examination of
- Raw Materials
- In-process samples
- Product release testing
- Medical devices
- Preservative Efficacy Testing
- Potency Assays
Why identify? To assess risk, identify source of contamination or prepare a strategy for contamination control.
We use a combination of traditional and rapid biochemical identification methods.
Environmental Monitoring and Analysis
Environmental monitoring can be carried out at our client's premises as a service and can include microbiological active air sampling, settle plates, surface monitoring using contact plates or swabs. Hygiene audits can also be performed.
Microbiological Method Development and Validation
With the ever increasing pressure on headcount suffered by most companies, time consuming method development activities become increasingly difficult. We are able to perform these activities to your specified criteria or if you have existing microbiological methods which have not been validated we are able to write the validation protocols and perform the validation to help you achieve compliance.
MGS are keen to work in partnership with our customers to achieve the technical excellence and the level of customer service you require.
We are able to offer bacterial endotoxin testing of water and finished products using
- Gel Clot and
- Turbidometric Assay techniques
Population determinations and enumeration performed on a range of different biological indicator types.
Microbiological assays performed to determine the potency of various:
Both EP and USP assays performed.
Preservative Efficacy Testing (PET) / Antimicrobial effectiveness testing (AET)
PET/AET testing is used to assess the performance of the preservative system in a finished product or as a tool in formulation/product development.
A known high level of the organisms under study are inoculated into the product under test and thoroughly mixed.
Aliquots of the inoculated product are withdrawn at pre-defined time points and enumerated using standard microbiological techniques and reduction in population calculated by subtraction from the initial inoculum level.
MGS personnel are fully trained and experienced in Preservative Efficacy testing and conduct hundreds of such tests annually.
Tests performed to either:
- EP 5.1.3
- ISO 11930
Testing of Antimicrobial Fabrics or Plastic Products
AATCC 147, Antibacterial activity assessment of textile materials parallel streak method.
AATCC Test Method 30, Antifungal activity, assessment of textile materials: mildew and rot resistance of textile materials.
AATCC Test method 100, Antibacterial finishes on textile materials: Assessment of
ISO 22196 / JIS Z 2801, Antimicrobial products – Test for antimicrobial activity and efficacy.
ISO 20743 / JIS Z 1902, Textiles – determination of antibacterial activity of antibacterial finished products
ISO 20645, Textile fabrics, determination of antibacterial activity – agar diffusion test.
ASTM E2149-01 Standard test method for determining the antimicrobial activity of immobilized antimicrobial agents under dynamic contact conditions.
Medical Device Products
ISO 11737-1 Sterilisation of medical devices-Microbiological methods, Determination of a population of microorganisms on products.
BS EN 14729 Opthalmic optics-Contact lens care products- Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses.
BS EN 14730 Opthalmic optics-Contact lens care products- Antimicrobial preservative efficacy testing and guidance on determination of discard date
MGS undertakes microbiological shelf life stability testing. We are able to store samples under controlled conditions of temperature and humidity as defined in ICH Q1 guidelines.
Current storage conditions offered:
1. 250C 60% RH 2. 300C 65% RH 3. 300C 75% RH 4. 400C 75% RH
All chambers wirelessly monitored 24 hours a day, 7 days a week with electronic alarm notifications enabled.
Dependent upon demand, additional capacity may be available for storage under conditions different to those above. Please enquire for details.
For customers who prefer to store their own stability samples, we can offer a service whereby we manage all other aspects of the testing program including ensuring samples are removed from storage at the correct time, sample collection, testing and communication of results either by exception or in full.
Contact us to discuss your specific requirements or to obtain further information on the services we can offer.