Microbial, foreign material, or THC/CBD contamination in starch molds
Running out of reusable or single use molds
Product too expensive due to production style and/or mold cost (no more than a $0.10 increase to the selling price to break even)
Employee safety if using combustible materials
New mold style needs to prevent cross-contamination between products so there is zero risk
The production time to make the product should decrease
The complexity of the gummy shapes possible should increase
Ensure at least 20% extra molds that production would not have to stop due to lack of molds
FDA Code 21, CFR 120: HACCP manages food safety by analyzing & controlling various hazards from raw materials through manufacturing the final product. One specific chemical hazard relating to gummy molding would be the potential flammability of the starch used in starch moguls. In general, this can apply to many potential hazards including hazardous chemical s or biological pathogens which may be applicable for this project (Hazard Analysis and Critical Control Point (HACCP) Systems, 2012).
FDA Code 21 CFR 110-111: GMP’s are recommended practices for ensuring consistent safety and quality of a product; this federal code outlines these recommendations. This involves various aspects including good equipment design, well trained personnel, and establishing control systems. GMP’s affect various aspects of the design and procedures for food manufacturing, and thus is relevant for this project because our design should comply with GMP’s to be suitable for adaptation to a manufacturing environment. It should be considered with our design whether any changes to normal food processes may require other adjustments to the food process to ensure GMP’s are met; for example, adding a metal detector control if adding a machine which adds risk of metal contaminating the food (Current Good Manufacturing Practices in Manufacturing, Packing, or Holding Human Food, 2012).
FDA Code 21 CFR 110.40: Hygienic equipment design is an aspect of GMP’s; it is briefly covered in the federal code, but there are third party regulatory agencies which certify companies for having hygienic equipment design. This is basically about ensuring that all equipment is easily cleanable to ensure sanitary conditions and safe food. This is relevant for ensuring our project design satisfies hygienic design criteria. For example, ensuring the molds which are used are adequately sanitary; this includes there not being crevices, which are hotspots for bacterial growth, and that internal angles meet criteria to be adequately cleanable. Another aspect is equipment such as the extruder being set up in a way to ensure adequate drainability (EHEDG, 2018).
FDA Code 21 CFR 174-178, 180, 186, 189: These regulations pertain to indirect food additives; materials in food contact surfaces are considered indirect food additives for regulatory purposes. The specific sections are as follows:
-174: General
-175: Adhesives & Coatings
-176: Paper & Paperboard
-177: Polymers
-178: Adjuvants, Aids, & Sanitizers
-180: Permitted temporarily pending further study
-186: Substances GRAS
-189 subpart D: Substances which are prohibited from use in human food
For this project, a variety of possible molding materials were discovered as options during patent research. As part of evaluating these materials to determine what to use, it is helpful to verify that they are indeed safe to use as food contact materials according to regulations.
List of substances:
-polypropylene: listed as safe in 177.1520
-polyethylene: listed as safe in 177.1520
-polyvinyl chloride (PVC): can be safely used as basic polymer (177.1200); if combined with other substances, may or may not be permitted so recheck regulations pending specifics.
-polytetrafluoroethylene (PTFE): is allowed but must not exceed thermal instability index=50 (177.1550).
-Silicone: listed as safe in 177.2600
(Indirect Food Additives: Polymers, 2012)