When a pharmaceutical manufacturer completes crude extracts from extraction, fermentation, or synthesis processing line, they will get a certain amount of mixed material from natural resources. But these raw materials contain various fractions and particles that are not suitable and unhealthy for human consumption or medical application.
A complete solution for purification and separation is required to further isolate and get high-quality, purified components, which meet the standard application in pharma, food nutrients, and cosmetic sectors.
The purification process of active pharmaceutical ingredients (APIs) is a complex and critical operation that requires a comprehensive solution. The rest of this article will take you to look into the 8 key typical steps that are particularly used for a complete purification process of natural ingredients on a large industrial production line.
Step 1: Product Acquisition:
The most commonly used process for raw material acquisition is extraction, fermentation, and chemical synthesis. How are you going to isolate a complex mixture is largely decided by these initial vital process flow designs according to natural product physical or chemical characteristics.
As a beginning stage, no matter whether you are going to purchase the natural sources directly from a manufacturer of pharmaceutical raw material or collect the natural extracts from your own process production line, multiple layers of process equipment must be properly selected for the separation of natural products.
The raw material fraction is complex and extracted components are always containing a fairly low content of APIs.
Here we are showing you an example of a practical process flow for crude fish oil extraction from deep marine fish species.
The process flow design of natural fish oil is always essential to the whole production line. During this process, raw materials are cooked in the cooler and will be sent to the press to separate into solid cake and liquid. The solid cake will be sent to the meal processing plant while the press liquid is entering into the tricanter and centrifuge for isolation and getting crude fish oil material.
Our company will choose different process equipment for you according to the different raw materials origin to guarantee the quality and yields of your natural product.
Working conditions like temperature, flow rate, viscosity, pressure, capacity, and vacuum degree, etc are critical factors to consider in the process equipment selection. For detailed process requirements, please send us your capacity for technical and commercial discussion.
Step 2: Pretreatment of Material:
When the crude liquid is extracted as a mixture state, it contains so many impurities and must be pretreated to remove any contaminants or particles that may affect the efficiency of the purification process.
There is a big amount of water or solvents that must be removed, which is not needed in our final purification process. So highly efficient multi-effect concentrators with condensers are superior supporting equipment to enhance processing efficiency.
But if you need to recover a certain solvent, like ethanol, methanol, isopropyl alcohol, polyethylene glycol, etc. we need to properly design a complete solvent recycling system.
Another simple process operation is required for treating crude fish oils with gentle bleaching, crystallization, and filtration for the next concentration and separation production.
Our specially designed thin film and short path distillation system are highly applicable for fish oil ester concentration to up to 55 – 60% by weight, under a moderate heating temperature that avoids polymerization and Isomerization situations.
Step 3: Solvent Preparation System:
Since we need a solvent preparation system to prepare the solution in the purification process. You need to do lots of studies and select the proper solvents before the process operation. The types of solvents used will depend on the product’s nature and the purification process’s desired target purity and content.
You may find the 15 most used solvents in the below link.
For safe solvent utilization in the pharmaceutical and chemical fields, there are strict regulations and process operation requirements for follow-up utilization and selection, you may find more solvent recommendations on the FDA Q3C table and lists.
https://www.fda.gov/media/133650/download
Step 4: Purification Process Plants:
For sure the core differential know-how that lies in the purification process plant is the actual purification and separation of the natural component product. This is typically completed using a combination of distillation or rectification, crystallization, extraction, membrane separation, and chromatography technologies.
It must be the most rigorous and comprehensive process development procedure that starts from a lab. scale testing, detection and process verification, pilot plant testing and verification, process analysis and optimizations, and expanding to small amounts of material testing and adjustments, and finally large-scale production PID and solutions. All these fundamental works are carried out to secure the best cost-effective purification process solution.
As a powerful technique, borne for large-scale production of natural APIs monomers, we use simulated moving bed (SMB) technology with multi-columns of high-performance chromatography separation system for acquiring target valuable high purity and content omega-3 long-chain polyunsaturated fatty acid (Omega-3 LCPUFA). The process is optimized to achieve as high as 97%wt content and 98% purity or higher, the continuous purification process makes solvent consumption at low level and highly efficient working performance.
Step 5: Collection and Consolidation System:
After purification, the natural product must be collected and consolidated into a single, high-quality product. This step may involve fine filtering, blending, or mixing the purified products. End product manufacturers are always on the lookout for purity and content in the ingredients for marketing claims as well as delivering superior performance, as usually higher concentrations of ingredients are required to provide the desired effect.
When coming to the final process of refining and formulation of high-content fish oil Omega-3 fractions, experienced manufacturers adhere to stringent process operations and maximum limit the oxidation level with Peroxide value (PV) < 5meq oxygen/kg oil and p-Anisidine Value (p-AV) < 20.
Step 6: Solvent Recovery System:
The use of solvents in a purification process is a double-edged sword. It can largely improve the operation process efficiency but also brings trouble in recycling and removing. A solvent recovery system must be employed to recover and reuse the solvents to minimize waste and cut costs on the production line.
Sometimes, when natural compounds are found more soluble in high-content or pure dry solvents, like ethanol, acetone, methanol, Methyl acetate, Isooctane, Toluene, etc. A precise process design must be considered in the solvent recovery system.
Greatwall Process and Control have been supplying solvent recovery and dehydration equipment with specialized molecular sieve pervaporation membrane units, features for solvent recovery, and dehydration to get target purity and capacity.
The system recovery efficiency is as high as 99% or more. The skid-mounted modular design is working continuously stable and is compatible with various process flow operations.
The detailed process designs are based on the solvent type and fraction ratios and target capacity and working conditions, please send us your process requirements for discussion.
Step 7: Post-processing Plant:
After the purification process, the product may undergo further post-processing to refine and improve its quality. This may involve recrystallization, drying, packaging, and other processes as necessary.
Step 8: Utility Supplying System:
A complete purification system must be supported by appropriate utility-supplying systems to ensure stable working conditions. This step may include fundamental infrastructure constructions for electricity, water, air, nitrogen, heating sources (normally thermic oil or steam), and other necessary supplyings for a highly efficient operation of the complete purification process plant.
Conclusion:
The above 8 steps can be modularly designed with process-proven technologies and compatible with process systems to ensure a highly efficient natural ingredients purification and separation. Greatwall Process and Control is dedicated to providing modular design of separation process solutions for natural ingredient purification and separation production.
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