QUICK CHANGE OVER IN THE PHARMACEUTICAL INDUSTRY
The Single Minute Exchange of Die (SMED) technique although originated in the automobile industry has proved to be a major threshold in various other industries also. In the late 1950s, Shigeo Shingo, a consultant of the then small automobile company named Toyota realized that large pieces of equipment requiring die changes for the manufacturing of metal sheets was taking too much time resulting in the production of large batches which increased overall costs of the company. SMED was born to facilitate quick changeover of the die. He has written a great book, A Revolution in manufacturing, which describes and guides the reader in a step-by-step manner in this methodology.
Contrary to popular perception, the methodology of SMED is not exclusive to light engineering industry or specifically to sheet metal industry. Over the years, I have come across the application of this methodology in several industries like, Pharmaceuticals, Oil Refineries, Paints, Plastics, Food Processing, Textiles, Soaps, Shoes, and so on. The list is endless. The possibilities are infinite. Sky is the limit for applying to core knowledge of SMED and extend it to improving the process wherever there is a changeover.
Proper implementation of this technique is of great importance in the industries with batch processing. The common problem faced by such companies is heavy production of material in batches. A large Pharmaceutical Formulation Plant has several distinct production areas and it manufactures hundreds of stock-keeping units (SKUs) in batch production mode. In one area technicians blend APIs (Active Pharma Ingredients, the drug) and other key materials (called Exepients) in huge stainless steel equipments. The blend is then compressed into tablets of different sizes based on potency requirement in rapidly rotating machines. Sometime blends, when transformed into a form of pellets, are used for filling into capsules.
Subsequently, depending on their drug release pattern, tablets are coated or left uncoated. The pills are inspected to weed out bad ones. The good ones are then sent to packing lines to pack them in different quantities in blisters, strips, bottles or pouches.
In some plants, there are lines for injectables, gels, lotions, ointments and liquids, which are closer to continuous process, which differ significantly from the process of manufacturing tablets and capsules.
All these different products, processes, packaging means a mind-boggling amount of changeovers which, in a typical plant, can take anything from 30 minutes to nearly 4 hours ! The longer the changeover time, the larger the size of the bath that has to go through such a set up. Larger batches mean the time taken between producing two batches will be very long. This, in turn, means some products will be is short supply and some other products will show a huge surplus inventory. batches. Thus we see that a pharmaceutical factory produces large batches of materials because:
Supplies take a long time to retrieve
Cleaning up from the last batch takes long
Equipments used cannot process small batches
Production of small batches may have great variations.
Once the exact reasons are categorized, applying quick changeover methodology in pharma industry becomes easier and effective as well. In today’s market pharmaceutical manufacturers are experiencing unprecedented market conditions. They are facing tough market competition and the SMED technique has helped them to speed up their process and reduce cost and unnecessary wastage.
Pharma industry enjoys some major advantages by the application of the SMED technique as it helps in reducing the batch size of the products thereby reducing the stock abundance and immobilized capital and prevents wastage due to over production. Also, Simplified operations can be performed without much variation and ensure consistent quality.
All this underscores the urgent need for and relevance of SMED in the pharma sector.
The SMED technique has not only proved vital for Toyota but for various other sectors like pharmaceutical sector and companies involving manual assembly processes. Service organizations also benefit from the SMED technique.