Ushering in a new era of improved safety and quality in milk banking
The Medolac Process & Safety
Medolac has developed the first shelf stable human donor milk. With the ability to ship and store the milk at room temperature for a prolonged period of time, significant cost savings result compared to the pasteurized, frozen donor milk offered by Medolac’s competitors. And, unlike its competitors, the Medolac products are commercially sterile, virtually eliminating the risk of disease transmission by destroying pathogens and spores that can be dangerous for hospitalized infants who often have weakened immune systems. Another unique attribute of Medolac’s products is its proprietary homogenization method, which prevents the fat portion of the milk from sticking to the inside of the infant feeding tubes and prevents the separation of cream and skim portions. Medolac’s thermal process destroys the spores of bacillus cereus, a ubiquitous pathogen that causes food poisoning and presents a salient risk to fragile infants. Medolac’s product line provide products with a range of caloric and protein density, making it possible to customer an infant’s nutritional therapy to better meet their needs. Medolac has developed additional products that will be the subject of growth and tolerance studies in the near future.
Medolac utilizes processing methods and standards that are regulated under the FDA 21 CFR 108 covering low-acid foods packaged in hermetically sealed containers (LACF) regulations as well as the FDA Food Safety Modernization Act. Medolac is required to comply with the following regulations: Registration requirements of 21 CFR 108.35 (c) (1) for LACF as well as process filing requirements of 21 CFR 108.35(c)(2). Under these regulations, Medolac’s federally registered facility is audited at least once per year for both the LACF regulations as well as the Food Safety Modernization Act. We have had a total of three FDA inspections with no corrective actives cited. The same process is used to thermally treat preterm infant formula because of its ability to create a commercially sterile product and destroy spores that present a risk to preterm and immune compromised infants. Under 21 CFR 113 and 114, we are required to maintain complete records of processing, production and initial distribution of the food products we process and thermal processing logs for each retort processing unit utilized in the facility. Under 21 CFR 117, Medolac complies with regulations regarding Current Good Manufacturing Practice, Hazard Analyses and Risk-based preventative controls. Medolac also holds current tissue bank licensing in the three states that mandate such licensing: California, New York and Maryland. The Company has passed inspection and audits under the tissue bank regulations for each State and annual inspections by the FDA.