Gone are the days when pharmaceutical manufacturing facilities had relied on developing the same product year after year.
Targeted therapies that need to be manufactured in smaller volumes for smaller populations means the industry is seeing a transition away from single-line-single-product setup in favour of multi-product manufacturing facilities.
At the manufacturing level, pharmaceutical manufacturers are leveraging advanced technologies and automation to address challenges such as sample under fill and overfill, detect contaminants and other dense foreign particles on the manufacturing line. Such solutions help pharmaceutical companies to address the issues.
As innovative technology is advancing in every industrial sector, the way we operate our equipment is always changing. With new advances in technology come a bigger focus is how it can improve to manufacturing volume, to reduce downtime and safety hazards, and to streamline costs in a variety of applications.
Till the recent past, most pharmaceutical manufacturing companies relied on a process known as batch manufacturing to supply their products to the public. However, with the proliferation in certain drug products, continuous pharmaceutical manufacturing has gained more prominence.
While batch processing and continuous flow manufacturing are great tools within the pharmaceutical industry, both have their ups and downs depending on the needs of pharmaceutical manufacturers.
In pharmaceutical manufacturing, artificial intelligence (AI) helps to enhance drug quality during manufacturing and compliance with standards. Artificial intelligence helps proactive detection of safety risks either to people or to the business in the pharma manufacturing plants.
Artificial intelligence can monitor access of people and vehicles to restricted areas or areas with a high risk of contamination. Artificial intelligence systems can stop equipment and machines automatically to ensure safety.
Artificial intelligence enhances production visibility by identifying bottlenecks, which impacts productivity and quality, estimate inventories, verify product packaging, and prevent or anticipate machine failures. Artificial intelligence helps in providing a continuous flow of information which improves process visibility for making real-time decisions.
Pharmaceutical industry trends include artificial intelligence, additive manufacturing, blockchain, and others. Artificial intelligence uses learned machine intelligence to perform tasks and make predictions. Artificial intelligence within the pharmaceutical industry has many purposes that can speed up the discovery and development of novel drugs. Artificial Intelligence is becoming a universal term in many industries today.
Wet granulation
The method of wet granulation is the most widely used preparation process of tablet. In this method the powders are bound by suitable binder by adhesion. The binder is included by diluting with suitable solvent prior to addition to the blended powders to form wet granules which in turn are dried suitably to expel the solvent forming dried granules.
Wet granulation process consists of dry mixing, wet mixing, milling of the wetted mass, drying, milling of the dried mass and finally blending.
Wet granulation process is a widely used method for manufacturing of compressed tablet. It is essentially a process of size enlargement involving several steps and the use of an adhesive substance known as binder. The granules manufactured using this method is meeting all has a greater probability of the physical requirements for tablet formation.
The process of wet granulation consists of a number of steps which include - weighing and blending, preparing wet granulate by adding the binder solution, screening the damp mass into pellets.
Dry granulation
Dry granulation process is used to form granules without using a liquid solution. This type of process is recommended for products which are sensitive to moister and heat. Forming granules without moisture requires compacting and densifying the powders.
Dry granulation can be done on a tablet press using slugging tooling. The compacted mass is called slugs and the process is known as slugging. The slugs are then screened or milled to manufacture a granular form.
The main advantage of dry granulation is it requires less equipment and eliminates the addition of moisture and the application of heat, as found in wet massing and drying steps of the wet granulation method. The manufacture of oral solid dosage forms like tablets is a complex multi-stage process under which the starting materials change their physical characteristics a number of times before the final dosage form is manufactured.
The main difference between dry granulation and wet granulation is that dry granulation is the process of forming granules without using any liquid solution whereas wet granulation is the process of forming granules by adding a granulating liquid.
Continuous manufacturing
Most pharmaceutical manufacturers are turning to continuous manufacturing processing for developmental drugs in their pipeline. Traditional pharmaceutical batch processing sees the various components of a drug brought together through a step-by-step process. As the materials go from step-to-step, the current batch must finish before a subsequent batch can be processed.
Continuous pharmaceutical manufacturing process sees a drug taken from its base ingredients to the final product with no need to stop during manufacturing. This means there is no need to cease the operation of the equipment and no down time as the product is created.
Batch processing must stop from step to step throughout creation while the continuous process creates a product with no need to stop until the product is completed. Both processes provide pros and cons to the manufacturer, and either one is a perfectly sound way to produce a great final product, depending on needs.
Batch manufacturing
Advantages of batch manufacturing is that the set-up costs are initially less expensive. Also, each batch is more easily tailored to be unique. Lastly, there are certain products that need batch manufacturing due to their composition.
Using batch manufacturing, pharmaceutical manufacturing companies can manufacture specific amounts of a certain product and then adjust their manufacturing priorities according to demands of the markets.
Conclusion
There are two methods of manufacturing in pharmaceutical industry – batch manufacturing and continuous manufacturing. They both differ in the way the process advances throughout the manufacturing process. Batch manufacturing is traditional yet proven method of manufacturing a pharmaceutical product with safety, integrity, and desired therapeutic properties.
Key advantage of continuous manufacturing over batch manufacturing, is that it can expand the available processing space, in terms of capacity and capabilities. Effectively shrinking the size of the necessary equipment not only reduces the footprint of the manufacturing space needed, but also makes key process parameters like temperature and pH easier to control within the chemical process.
(The author is a practicing chemical engineer based in Mumba) |