Improving Productivity by Optimizing Manufacturing Processes

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“Without a product license (domestic and imported packaging material) it is not possible to supply there. This license has to be renewed after a certain period of time. The US FDA does not request for the supplier of the packaging material to be audited by the FDA. The production has to be done under the newest GMP guidelines and each material that is exported should be registered in the active DMF.”

Another such guideline is PAT, which is a framework for innovative pharmaceutical development, manufacturing and quality assurance.

“This guidance is intended to describe a regulatory framework that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance. Working with existing regulations, the agency has developed an innovative approach for helping the industry address anticipated technical and regulatory issues and questions,” states Maennl.

Defining Automation Technology

With regulations in place what comes next is using high end technology specially in a critical industry such as pharma. The importance of cleaning-in-place (CIP) and sterilization-in-place (SIP) is growing rapidly in all relevant markets. Explaining the terms Maennl says, “While CIP is a method of cleaning the interior surfaces of pipes, vessels, process equipment, filters and associated fittings, without disassembly, sterilization is a term referring to any process that eliminates (removes) or kills all forms of life, including transmissible agents (such as fungi, bacteria, viruses, spore forms, etc.) present on a surface, contained in a fluid, in medication, or in a compound such as biological culture media.

Sterilization can be achieved by applying the proper combinations of heat, chemicals, irradiation, high pressure, and filtration.” In the pharmaceutical industry, higher demands for the processing of active pharmaceutical ingredients (APIs) in contained environments and the higher degree of automation call for more and more sophisticated technologies.

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