As with any consumer good, maintaining high quality standards during the manufacturing process of dietary ingredients is key to avoid any undesired effect or product recall. This is especially relevant nowadays, with the increased number of outbreaks due to contaminated products. These include bacterial infections (mainly Campylobacter or Salmonella), the presence of pesticides, heavy metals, or allergens, or contain undeclared ingredients. Any of these factors can potentially compromise the health of millions of consumers, which is the reason why all governments have a dedicated agency to ensure that the products available in the market are safe to be consumed; for example, the Food and Drug Administration (FDA) in the USA and European Food Safety Authority (EFSA) in Europe.
Unfortunately, product recalls are on the rise, causing companies to lose millions and potentially jeopardize their own existence. Therefore, many are starting to apply stricter production processes, going from having a deeper control in the raw material source, to implementing safety measures during product development. In the latter case, having a safe and sterile environment for product production is important, which is the reason for the increased interest in using cleanrooms.
Cleanrooms are designed to meet the strictest demands for manufacturing. It is built to be part of the production facility, but completely independent. This includes an exclusive access and exit point, strict ventilation and filtering systems, and complete climate control. The floors, walls and ceilings must be hard, smooth and easily cleanable. The rooms must be able to allow temperature and humidity control, and the air supply must include HEPA filters to block the entry of external particles or contaminants. These strict measures ensure that the environmental microbiological flora is adequately controlled, avoiding contamination from outside sources.
But having a cleanroom as part of the production facility is irrelevant if the staff are not adequately trained to work in the special conditions that are necessary. They must wear special clean suits and masks, that cover all body parts, and have to access the cleanroom though a special antechamber called the air shower, which ensures that they enter the room free of contaminants. The maintenance and cleaning staff must also be trained in order to ensure that the cleanrooms remain in proper condition and sterile.
In Monteloeder, we strive to meet the strictest quality standards. Our manufacturing facilities are built to include several cleanrooms, with the ability to prepare powder and liquid blends under ISO 9001 standards. We are also GMP certified for the validation of dietary supplements (21 CFR 111) and food products for human consumption (21 CFR 117). We can also perform validations of cleanroom and equipment cleaning, as well of production processes.
Our facilities allow us to manufacture both the necessary quantity (up to 50 metric tons/month) and quality that our clients need. We also have the ability to adjust to any particle size, and can perform pharma-quality sieving and milling.
Therefore, Monteloeder only provides the best quality products, meeting the necessary standards that the industry demands.
By:
Fran Cremades – Technical Director and Quality Control Manager.
Elena Rico – Quality Assurance Manager
