Indian pharma manufacturers need to invest in energy efficient and cost effective equipment for cleaning. The existing cleaning equipment is absolutely outdated. The most visible consequence of outdated cleaning approach and equipment are the warning letters issued by the USFDA and other regulatory bodies. All these warnings are related to equipment cleaning and maintenance, said Torben M. Andersen, VP, projects & technical management, McFlusion.

The industry here also follows highly ineffective and wasteful cleaning which is directly affecting the bottomline of companies. In the wake of US FDA observations, pharma manufacturing facilities will need to execute specific Cleaning in Place (CIP) and Sterilisation in Place (SIP) assessments. The CIP engineering studies for drug manufacturing facilities will address and present solutions to cleaning challenges. The companies will be required to implement the necessary upgrades to existing cleaning processes and equipment, noted Andersen.

Most pharma companies follow traditional equipment maintenance and cleaning principles. These techniques are neither the most efficient nor can these methods be easily validated for difficult-to-clean equipment and substances. CIP/SIP techniques are used in the pharma and food industry to clean and maintain plant equipment hygiene conforming to cGMP and FDA guidelines. It is an integral part of the manufacturing process to ensure product quality repeatedly. This is where Uventis Bioscience represents McFlusion in India to introduce advanced technologies in equipment maintenance and cleaning which are cGMP and FDA compliant processes that can be validated, he added.

“We believe that a technologically superior solution together with a process driven approach will minimise chances of errors and make manufacturing process fully compliant with exacting US FDA standards. Only if a validated equipment cleaning process is adopted which is embedded with analytical and software control, it can effectively address issues related to cleaning and validation of equipment, coupled with huge savings in energy and consumables such as water and solvents,” said Anderson.

Currently, McFlusion has no direct competitors either in India nor globally. It serves as subject matter experts (SME) and is engaged in guiding and assisting drug manufacturing facilities to optimise CIP and SIP to meet regulatory requirements, increase efficacy, reduce water and chemicals, reduce cleaning time, etc. It also extends operator training, educational seminars, preventive maintenance, online 24/7 support.
 
Most major pharma and biotech companies in the US and Europe have McFlusion technologies integrated into their manufacturing processes, said Andersen adding that the two decade old company has its manufacturing and test facilities at Canada and Denmark, engineering-warehouse at Ohio with remote engineering offices at New Jersey, Oregon and Puerto Rico with technical sales & support offices in India and Australia.