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Indian pharma needs energy efficient cleaning equipment to keep US FDA warnings at bay: Torben Andersen
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Nandita Vijay, Bengaluru
June 23 , 2017
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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absolutely outdated. The most visible consequence of outdated cleaning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.
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