Under the Microscope: Our Quality Control
Quality, efficacy, safety, these are our top priorities when it comes to manufacturing life-changing products. For this reason, New Earth’s manufacturing facility exceeds the highest standards in the industry, providing quality and purity in products that you can depend on.
We maintain our own manufacturing facilities which are registered by NSF International to FDA’s Good Manufacturing Practices (GMP) and GMP for Sport™. We’ve also earned certifications for Kosher, Halal, Paleo, and USDA-Organic. Each of these certification agencies have their own standards and requirements; however, there are many areas in which their standards cross over.
What does this mean? For you, peace of mind, knowing these are products you can trust. For us, this means maintaining a state of the art manufacturing facility and quality control program that complies with the highest standards of our certification agencies.
Quality control encompasses every aspect of the production of our products—the process is very comprehensive, including extensive documentation and documentation control.
Production Facility: New Earth has established Standard Operating Procedures (SOPs) that govern every aspect of production. We follow meticulous processes for maintaining standards of cleanliness, including the use of state-of-the-art equipment such as stainless steel food-grade tanks and lines.
Harvesting: New Earth’s harvesting and processing procedures are closely monitored and optimized to preserve nutritional integrity. Quality Control (QC) collects and analyzes samples of the lake’s biomass from potential harvest sites. Once favorable test results are complete, harvesting proceeds. The lake harvesters collect Wild Microalgae™ from the surface of the lake and de-water the microalgae. The microalgae is chilled in order to retain bio-essences and nutrients and is quickly transported to the production facility in order to maintain freshness and nutritional value.
Processing: The microalgae is cleaned to remove any extraneous material before going to the plate freezers, in which the microalgae is frozen at -10 °F.
The frozen microalgae is then sealed in food-grade plastic bags and packed into totes. QC samples are taken from each tote and boxed in preparation for QC testing. All samples are labeled to match the corresponding tote.
Each tote is issued a barcode and placed in a climate controlled freezer until released for drying. The information documented on each barcode includes the type of product, date, batch number and other pertinent identification data. These codes are used to track the algae through the entire process.
Frozen QC samples for each batch are dried and blended into a composite sample for QC testing. Samples are shipped to third party laboratories to test for any potential contaminants . Once acceptable results from the third party labs are complete, QC will notify the Inventory Controller, who will arrange shipments of the frozen microalgae to a third party dryer.
Frozen microalgae is shipped to a third party dryer in food grade totes. Even the trucks that transport the algae must meet sanitation guidelines. Once the microalgae has reached the drying vendor, it is dried in a low-temperature drying process (Bioactive Dehydration™) that preserves microalgae nutrients. A proprietary Oxy-Guard system is employed to prevent oxidation during drying. The drying process meets the guidelines for both organic and kosher certifications. Dried microalgae is returned to our facility in sealed Mylar bags inside a box.
Microalgae that is received from the drying vendor is placed into inventory and sorted by batch and type. The microalgae inventory is quarantined inside a refrigerated warehouse in preparation for further testing, in-house processing, or shipment to third-party contract manufacturers. Temperature and humidity are controlled and monitored.
Laboratory and Quality Control: The Quality Control department collects samples from each batch of dried algae for analysis by the in-house laboratory and certified third-party laboratories. QC will approve dried microalgae only after test results meet product specifications. Analyses are performed for the presence of possible contaminants, such as natural-occurring toxins, microbial content, heavy metals, and pesticides and actives compounds (chlorophyll, PEA, phycocyanin, vitamins). After passing third-party and in-house laboratory testing, a COA –Certificate of Analysis—is issued for each batch; and each batch of microalgae is released by the QC department for further processing by the Production group or shipment to a contract manufacturer. The Inventory Controller is notified when each batch of microalgae is released.
Encapsulation and Bottling: Machines are used to encapsulate powdered ingredients in vegetarian capsules. These encapsulation machines are disassembled and cleaned after each use; and also allergen swabbed, depending on the ingredients used. In-house inspectors examine capsules for defects—defective capsules are removed.
Product capsules and tablets are filled on the bottling line. A metal detector is installed to ensure that no metal particles are present in the product. In addition, compressed air lines are filtered and monitored to check for, and prevent possible microbial contamination.
Finished Product: Finished products are stored in either refrigerated or room-temperature warehouses, according to product specifications, until being shipped to customers. New Earth’s Quality Control department samples, inspects, and analyzes each lot of in-house and vendor-finished product for conformity to product specifications. When a finished product passes all quality control tests, a Quality Control Release is issued to the Inventory Controller and Warehouse Manager. Once a lot has been released, it is delivered to the shipping floor for filling customer orders.
Storage: Prior to shipping, the product is stored in a GMP regulated, refrigerated warehouse to preserve product freshness. Temperature and humidity are controlled and monitored.
Ingredient suppliers: A number of our products contain ingredients sourced from other suppliers. Whenever possible, we try to obtain certified organic ingredients. At the very least, we ensure that all ingredients are all natural, quality tested, and non-GMO. We deal only with reputable vendors whose standards for production meet those for which New Earth is known, including adherence to Good Manufacturing Practices as well as to regulations established by federal agencies including the Food and Drug Administration. Prior to purchasing, each and every supplier must be approved through the QC approval process. We deal only with vendors whose exacting standards equal our own.
As you can see, New Earth is diligent about guaranteeing the quality of the algae we harvest and the products we manufacture. We comply fully with the regulations of our certifying bodies and also consult with prominent algologists to remain current with the latest research and technology available. Every harvest undergoes stringent Quality Assurance procedures, ensuring that you receive only the highest quality finished products. We take pride in producing naturally wholesome, clean, safe, premium quality, nutritional whole food supplements.
