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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.
Poor industrial hygiene - the most frequent reason for complaints
In 2019, more than half a million food companies were inspected by the monitoring authorities of the federal states of Germany. The number of complaints remained the same as in the previous year at 12.9%. The most frequent complaints were violations of hygiene regulations: Nearly 50% of the complaints were about violations of the regulations
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Analysis of Glyphosate residues in our daily Products
Glyphosate is a non-selective herbicide used since 1974 in numerous countries worldwide. Lately, there is an emotional discussion in the media and consequently the number of reports on residues of glyphosate in food have increased substantially. Due to the high polarity of glyphosate it is not possible to analyze it together with the other pesticides
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Food Supplements in Online Shops
Food supplements are legally defined as foodstuffs which serve to supplement the diet. They are usually offered in the form of tablets or capsules and can thus provide the body with additional vitamins or minerals, for example. Obligation to notify food supplements Before a food supplement can be placed on the market, it
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We are shocked! - Dark chocolates tested
They say chocolate makes you happy – but only if it is safe and of good quality! 24 different dark chocolates have been tested recently, but not all of them were found to be good. According to the Cocoa and Chocolate Products Regulation, chocolate is defined as a product containing at least 43% total dry
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Biocompatibility: No plan - no report!
Among all the hurdles that the legislator has set up before medical devices can enter the market, the proof of biocompatibility poses particular challenges. Specialized service laboratories have an impressive number of corresponding tests in their repertoire: But which of these does your medical device really need? In principle, the answer to this
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DSI-pharm achieved GMP compliance for 400 MHz-NMR
In October 2020, a complete device qualification of the AscendTM 400 MHz-NMR (Picture 1) used by DSI-pharm was performed to achieve GMP ready status. This was carried out by GMP trained Bruker engineers and included testing the operation of the system to determine that it meets Bruker`s factory specifications as well as testing the computer
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