The most significant decision when making ointments is likely to be the choice between automatic or semi-automatic processes for it. This impacts on individual phases of the ointment cream manufacturing process – the water phase and oil phase.
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How to manufacture ointments
Before homogenizing ointments, you need to treat each of the product’s main components separately, in specialized vessels. The process begins at the water phase. In it, you dissolve the water-soluble components in demineralized water in a vessel that is proper for it. Next up is the oil phase, involving the mixing of the wax and oil components in a wax phase vessel. Motor-driven agitators heat and mix the containers, then a vacuum system filters and moves them through pipes to the ointment manufacturing vessel. At this stage, you introduce homogenizers and emulsifiers, to ensure that the mixing of the components (including the drug ones) is as uniformly as possible.
When the product is ready, it is time to transfer it to the storage tank, then move it to the filling machine. Finally, before filling the product into tubes, you can use a triple roller mill to remove extra water from the product. In the end, Clean-in-place (CIP) systems take care of all the containers used in the ointment cream manufacturing process.
Should you use the automatic or semi-automatic process?
The semi-automatic process is shorter and easier than the automatic process, and it also involves the use of fewer vessels. However, the automatic process ensures a more thorough processing of materials. Essentially, the automatic process is more cost-effective if you’re considering the large-scale production of ointments. The main difference between both processes occurs at the initial stage. In the automatic process, you heat the water-soluble and wax components in different vessels. On the other hand, you can use the same vessel to mix and stir all the different components. Also, a planetary mixer replaces agitators, while colloid mills act in place of homogenizers in this process.
What you should know about making and selling ointments
Under the FD&C Act, in the US, ointments can be both cosmetics and pharmaceuticals. Its categorization depends on the vehicle or base of your finished product. Vehicles include lotions, ointments, pastes, syrups, and suspensions. Vehicles in liquid dosage forms may be aqueous (water, hydro-alcoholic solutions, polyhydric alcohol), or oily (emulsified bases, vegetable or mineral oils, etc.).
Protective ointments are required to neither penetrate the skin nor facilitate the absorption of substances through the skin. These are regarded as cosmetics. Antiseptic ointments, on the other hand, need to be able to penetrate the skin and are regarded as pharmaceuticals. In general, while the FDA provides regulations for the manufacturing and sale of cosmetic products, you do not require a license before you set up a cosmetic production business. Also, the FDA typically does not need to approve cosmetic products before they go on sale. On the flip side, if your product is a pharmaceutical one, you need to get approval to both start-up and sell the product.