Active pharmaceutical ingredients production – green api manufacturing

Active pharmaceutical ingredients are produced on such a large scale that in the past few decades, the demand for their manufacturing process to be more environmental friendly, has increased.

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It is mainly because the hazardous waste produced by the active pharmaceutical ingredient production industry, is produced in thousands of tons every year. This waste is extremely difficult to get rid of and if the current manufacturing processes and practices are not bettered, the environment will keep decaying due to our carelessness.

To have a more greener approach towards API production, refining a chemical route, bio catalysis (for optimizing API synthesizing processes) and solvent reduction are some the techniques which are being used.

Making API production greenerThe simplest way in chemistry for reducing the produced waste, is by making the reaction cheaper, and on top of that faster.

API production based on chemical reaction, is simply about getting from point A to B. Now, doing so, requires one to take so many routes but if the number of routes are lessened, the end product will be B but the reactions required to achieve it, will be less. This will ultimately help us in making the reactions cheaper and faster, as noted before.

Another way to do this, is to use better catalysts which are more efficient and more environment-friendly.

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A study of GabapentinAt every API research and distribution center, attempts are being made to achieve the above which can help in increasing manufacturing efficiency and cut costs, which can be used for business expansion.

At Pfizer’s manufacturing facility in Singapore, the attempts of increasing manufacturing efficiency of Gabapentin (Neurontin) started, as they realized that competition was increasing.

A multi-disciplinary team, made by bringing together some of the best analysts, chemists and chemical engineers of the industry, was formed.

To begin the process of devising a new and greener method for API manufacturing, an examination of the plant’s current processes, system, capabilities and other factors, was organized by the company.

The gabapentin manufacturing process was reengineered in the end and a green process was developed.

Scale EconomyPfizer realized that to maintain the edge that it currently holds in the pharmaceutical industry, it required to upscale its production and increase manufacturing efficiency. Many companies are now starting to look towards greener processes of manufacturing as they do not only provide the company with an image of being green, they also help in cutting-down costs.

The factors such as time, labor, raw, solvents, required materials, and others were taken into account, before the process of reengineering the gabapentin manufacturing process started.

Research

Plant efficiency and throughputThe capacity of the manufacturing plants was inspected. In the overall process, each plant’s capability was checked and if there were any bottlenecks, attempts for reducing them, or removing them, were also made.

A hydrogenator is used in the gabapentin manufacturing process and these assessments are very valuable when it’s included.

Material usageExaminations were also made for the used raw materials, solvents, amount of reagents and the related costs.

ImplementationIn any plan like the one at Pfizer, the implementation is the key component as there’s literally no point of spending resources on making unimplemented plans. Pfizer took the decision of devising a plan which could be involved not only in their Singapore plant but in all of their plants across the world.

In this process, it was also to be determined that the new plan should be implementable without much costs and should, primarily, help reducing the environmental harm.

The challenges faced by the Pfizer team, are listed below:

Reducing CO2 emissions to match Pfizer’s standardsTo reengineer the process in such a way that the gabapentin production is increased while maintaining price efficiency.Maintaining quality and making sure that there were no impurities in the production as a result of the reengineered process.Using better process and capabilities, while using less energy, labor and capacity, while also reducing chemical waste.Lesson learnedPfizer succeeded in doing what they’d planned to because of the reasons listed below:

A more innovative chemistry towards the process was taken, which not only made the process more efficient but simpler.The crucial part in the success of the project was that the team knew about the overhead, target expenditures, costs, waste and materials.The financials involved in the processes were not only overseen by managers or financial officers but the scientists and engineers as well.The process made sure that efficiency of the process was involved and the process was made to be greener. It allowed Pfizer to cut on costs and retain its edge as an industry leader that it has held for many decades in the industry.

SGRL has been consistently adding capacities and fine tuning process to provide quality products at lowest cost to the customers. World over, Amine technology is a closely guarded process with only a few handful companies having access to such technology. SGRL for the first time in India tested on an indigenously developed technology and developed it further over a period of time.

Today, SGRL‘s products are accepted in international markets and have gained the distinct export quality status, which makes it one of the few companies in India having the potential to match the stringent international quality standards for which we have been awarded ISO-9001: 2000 Certification apart from appreciation and continuous orders from global majors for our product range.The Company operates the unique processes, synthesis and chemicals reactions for manufacture of their various products developed in house by their Research and Development Department.

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Ingenious Brandcare - Shree Ganesh Remedies Limited is an Indian Pharmaceuticals company and one of the proud subsidiaries of the Ganesh Group of Industrie which is presently having its headquarter in Ankleshwar in Gujarat