CONTRACT MANUFACTURING APPLICATION NOTES, WHITE PAPERS AND CASE STUDIES
CONTRACT MANUFACTURING NEWS
Beware of any scenario where the word “partnership” is used only to obtain a better price and/or more aggressive terms, as this is the origin of failed relationships. A true partnership should define terms that balance the risk and reward for each party.
Discover the 9 elements of a predictable quality system when evaluating CMO partners. Predictable quality shortens your time to market, reduces your compliance risk, and reduces risk to the patient.
As new technologies are incorporated into POC diagnostics, the challenges of taking product from design to full-scale commercialization increase. Is your supplier model as efficient as it could be?
With price competition and cost pressures squeezing the profitability of medical devices, supplier networks are the latest target for cost reductions — and rightfully so. Complex supplier networks add costs without adding value.
Collaborating with the right Contract Manufacturer (CM) can have many benefits including program management, risk mitigation, innovation, and a faster speed-to-market. It is important to choose an experienced partner to help the success of a program instead of hinder it.
Choosing the right vendors and managing them effectively can increase a manufacturer’s efficiency — in terms of time, cost, and quality. Unfortunately, suppliers can also sometimes put their clients in hot water when their quality standards are below par. With over 12 years of experience in medical device development, I understand how hard it is to find and keep compliant suppliers. Based on my observations working with suppliers in the medtech industry, these are some of the major issues that impact a device manufacturer’s compliance efforts.
The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.
About Nutrient Removal
Nutrient removal from wastewater consists of treating wastewater to remove nitrogen and phosphorus before it reenters natural waterways. High levels of nitrogen and phosphorus in wastewater cause eutrophication, a process where excess nutrients stimulate excessive plant growth such as algal blooms and cyanobacteria. The decomposition of the algae by bacteria uses up the oxygen in the water causing other organisms to die. This creates more organic matter for the bacteria to decompose. In addition, some algal blooms can produce toxins that contaminate drinking water supplies.
As authorized by the Clean Water Act, the National Pollutant Discharge Elimination System (NPDES) permit program regulates point sources, such as municipal wastewater treatment plants, that discharge pollutants as effluent into the waters of the United States. In recent years, many of the States’ environmental bodies have lowered nutrient limits to arrest eutrophication. Maryland’s effort to protect the Chesapeake Bay and its tidal tributaries is perhaps the most notable example of nutrient removal in the US. Nutrient removal continues to be a growing area of focus for wastewater treatment throughout the world.
The removal of nitrogen and phosphorus require different nutrient removal processes. To remove nitrogen, the nitrogen is oxidized from ammonia to become nitrate through a process called nitrification. This process is then followed by denitrification where the nitrate is reduced to nitrogen gas which is released to the atmosphere and removed from the wastewater.
Nitrification is a two-step aerobic process which typically takes place in aeration tanks. Denitrification requires anoxic conditions to encourage the appropriate biological conditions to form. The activated sludge process is often used to reduce nitrate to nitrogen gas in anoxic or denitrification tanks.
Phosphorus can be removed biologically using polyphosphate accumulating organisms (PAOs) which accumulate large quantities of phosphorus within their cells and separate it from treated water. Phosphorus removal can also be achieved by chemical removal. Once removed as sludge, phosphorus may be stored in a land fill. However, many municipalities and treatment facilities are looking to resell the biosolids for use in fertilizer.