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Challenge Testing (ISO 17025 Accredited).IntroductionOur company QACS Ltd, based in Athens Greece, is providing Quality Assurance & Quality Control services, supporting the cosmetics, pharmaceutical and household industries. Our services include, among others, EU registration, Microbiological and Physicochemical testing. We specialize in preservation efficacy testing, commonly known as “challenge test”. Our laboratory, has significant expertise in the Challenge Testing of cosmetics and pharmaceutical products, offering high-quality services at competitive prices. The company is serving a large segment of the Greek cosmetics industry and an increasing share of the Greek pharmaceutical industry. Adequacy of PreservationCosmetics need not be sterile, however, they must not be contaminated with microorganisms which may be pathogenic, and the density of non-pathogenic microorganisms should be low. In addition, cosmetics should remain in this condition when used by consumers. Preservation Efficacy Test - Challenge testEach cosmetic and pharmaceutical product should be tested during product development for adequacy of preservation against microbial contamination which may occur under reasonably foreseeable conditions of consumer use. The products that are desired to be protected (OTC, cosmetics, laundry detergents, dish detergents) are prepared with preservative and then inoculated separately with strains of bacteria and fungi. The samples are stored, then examined for survivors and these numbers recorded. Standard test EP, USP, BP, JPTest microorganisms used in the company’s testing protocols are representative of those likely to occur as contaminants during use and consist of Gram-positive and Gram-negative bacteria, mould and yeast. A detailed list of test organisms is available upon request.
Customized testChallenge test using "problem microorganisms" microorganisms isolated from the operating site. This type of testing is closer to real world situation than those purchased from ATCC. Mixed Culture TestsPreservation efficacy screening tests, designed to provide guidance during the product development stages. Designed to simulate repeated inoculation cycles or simgle inoculation followed by a storage period. Minimum Inhibitory Concentration (MIC)Preservative dosage, should be kept at low but efficient levels. Challenge test is the key to information on the minimization of aggressive substances, for safe and mild formulations. Evidence on Minimum Durability for Cosmetic Preparations (PAO)The European Union is currently regulated by the 7th Amendment to the Cosmetic Directive 76/768. Challenge testing provides documented evidence for the substantiation of the months and / or years that the product is safe to use after it is opened. Evaluation of Sanitizers Disinfectants and AntisepticsEvaluation of basic bactericidal fungicidal activity. Suspension tests in an environment simulating conditions of use according BS EN 1040 : 1997, BS EN 1276:1997, BS EN 1650:1997. Type of productsThe categories of products on which challenge testing is applicable include: OTC (Over-thecounter) products, Pharmaceuticals, Cosmetics, Detergents, Sanitizers. EN/ISO 17025 accreditation.ISO 17025 accreditation specifically for challenge tests: Besides the GLP certification, the company’s lab is the only laboratory in the EU, that is accredited under the terms of the ISO 17025 standard to carry out challenge tests. ReportingType of productsReport may be the standard or customized. Test duration is 28 days. Reports are available within 35 days from sample receipt. In case of negative readings clients are informed asap. Sample quantity from 200g to 300g. Documentation should mention the exact product description, company name, address, phone, fax, e-mail and VAT number. Competitive pricesThe company’s prices are quite competitive. Clients maintain operational costs at competitive levels and enjoy the benefits of increased added value on their products and services. We are confident that you will find our services competent and our prices competitive. You are invited to call us or visit our website at www.qacs.gr for any further information. A 24h courier transport service is offered. Contact us to arrange sample transport details. |
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