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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.
Bevacizumab and its biosimilars - treating cancer
FACES OF CANCER Over 100 types of cancer – a group of diseases involving abnormal cell growth with potential of invading and spreading into other parts of the body – affect about 100 million people worldwide, with over 8 million deaths anually. The risk of cancer increases with age and is more likely in developed
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Legionella Testing in Water
Protect your community and business against Legionaires’ disease outbreaks by monitoring water regularly for Legionella. Columbia Laboratories now offers ISO and TNI accredited Legionella testing in water. Columbia Laboratories offers a suite of water and environmental testing, and Legionella testing is key to continuing to protect communities. Should I test for Legionella? Any water system,
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Columbia Laboratories is CDPHE Certified!
After nearly a year of rigorous validations, on site audits and method review, Columbia Laboratories joined the short list of qualified testing laboratories. “Our Colorado clients have been very patient as we ensured proficiency and compliance while completing this accreditation process,” said Kelly O’Connor, sales director for Columbia Labs. “We made sure we have all
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One in four pre-cut fruit salads has defects
Food business operators are responsible for the safety of their products. This includes complying with hygiene requirements during food production, processing, storage and distribution. The company has to ensure that the facilities and materials are clean, the fruit is washed before cutting, the cooling temperature is maintained and the employees are trained regularly. If these
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The New FCC Honey Identity Standard
Some experts claim that honey is the third most adulterated food in the world. As the conversation around honey authenticity becomes more prevalent, as well as legal action against those who allegedly participate in counterfeit operations, a standardized guide for honey is becoming increasingly important. As of December 1, 2021, the new Honey Identity Standard
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Cannabis Shelf/ Stability Studies
Ensure shelf stability and longevity of your products with a shelf-life study at Columbia Labs! Shelf-life studies have been a staple of food safety in America for decades and are rising as a regulatory requirement across several emerging industries, especially cannabis and hemp-infused products needing to qualify for import, export and consumption. Columbia has
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