A Medical Device is any instrument, apparatus, appliance, software, material or other article intended to be used for a medical purpose and must be proven as safe and effective. …more
Ensuring every batch of life saving drug or vaccine is free from microorganisms or contamination is the responsibility of every pharmaceutical manufacturer and the expectation of every patient . …more
Biologic molecules differ from SMDs with regard to size, complexity and processing. Ensuring adequate controls of bioburden and endotoxin limits are critical to ensuring patient safety. …more
Cosmetics, personal care and cleaning products need to be effective yet dermatologically and environmentally harmless. …more
Helvic is an independent contract testing laboratory that has been providing microbiology analysis to the pharma sector since 2010.
Helvic is a pharmaceutical microbiological testing laboratory with a difference. Our passion is to offer industry leading Quality and Customer Service coupled with competitive prices.
We are committed to being best in the industry. Contact us to see how we can drive down your costs while offering market leading quality and service.
New regulations on Organic Products in 2020
New regulations for certified flavors in organic products will come into force in the USA in December 2019 and in the EU in January 2020. Food and beverage companies will have to check if the new regulation applies for their products. Use of flavors in organic food & beverage products in the U.S. From
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Testing Pharmaceutical Raw Materials
Any starting material intended for use in the production of medicinal products must be tested for identity, purity and quality. All deliveries of each batch of material must be sampled, tested and the results evaluated prior to manufacturing. As the identity, purity and quality of a complete batch of material is concluded from a small
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Listeria monocytogenes in Food - Challenge Testing
Repeatedly, public recalls of food occur by the qualitative detection of Listeria monocytogenes. The legal basis for these recalls is Regulation (EC) No. 2073/2005 on microbiological criteria for foodstuffs. Chapter 1 lays down food safety criteria for ready-to-eat foods which may favour the reproduction of Listeria monocytogenes and which are not intended for infants or
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Laboratory KUDAM presents its new website
KUDAM Laboratory presents its new corporate online space, which informs you about all its analytical services and the covered industries: Food and Feed, Agriculture and Environment KUDAM Laboratory brings more than 25 years of experience in the field of analytical services and supported many companies in their development. Since 2016, KUDAM is part of the
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New website for Helvic Laboratories in Stoke-on-Trent, UK
Helvic Laboratories, founded in 2010, are a Pharmaceutical Microbiology Laboratory with a difference. Our passion is to offer industry leading Quality and Customer service coupled with very competitive prices. We provide a complete range of microbiological testing services for the Pharmaceutical Industry. Helvic Laboratories – A Tentamus Company, are pleased to announce a new website
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How to ensure the safety of pharmaceuticals?
Impurities in drug products Pharmaceutical manufacturers use materials from a variety of suppliers to compose the final medicinal product for the market. Patient safety is of utmost necessity for these medicinal products. This is ensured by a network of guidelines summarized under the term GMP – good manufacturing practice. Under these GMP guidelines the
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