"Get the right people. Then no matter what all else you might do wrong after that, the people will save you. That’s what project management is all about."

The pharmaceutical industry is a highly innovation-driven industry that throughout its history has contributed to the well-being of humans by providing new medicines to address various diseases and has grown into one of the major sectors in the world.

However, in the past years, the industry has faced and continues to face several challenges in terms of delayed project timelines, deprived design of the system, increased R&D cost for new drug development, harmonization of all stakeholders from product conception to launch on design engineering front and rising customer expectation for new, cheaper and more effective therapeutic drugs in minimum time.

Project timelines have the potential to cripple the scope, cost, and quality of the project which in turn is due to the failure to understand the various aspects of the project life cycle with a Process lens instead of a Project Lens.

• One Size fits all approach when every drug is different
• Speed doesn’t mean half grilled R&D data be processed
• Key process elements of Design Migration-Beaker to reactor
• SME vs The Accidental Project Lead
• Absence of Process catalyst

Many industrial entities are struggling to adapt & on-board changes from R&D to commercial scale. Driving a product to the market safely, quickly, and cheaply is the best way for a pharmaceutical firm to be successful. It’s time to transfer our traditional emphasis from Project management to Process management to drive the project efficiently from R&D to commercial scale on process requirements.

Understanding & mapping the diverse set of challenges compared to customary project management and the need to attend to them immediately, PHS decided to assemble a team of process experts to address the issues and fill the vacuum in the process management field with excessive continuity from Pre-order stage to Post-Order. We are advising our customers for critical products from conception to a product launch by changing our vision and focus from traditional project management to process management.

Our engagement from the R&D stage with the customer’s technology team & assisting both sides (Tech & Commercialization) is focused on synchronizing with process requirements at conception itself with the sole objective to eliminate future road-blocks.

The KEY hence is to develop a comprehensive portrait from product development to product launch to fast-track the access of medicine to the patient.

“A soul is but the last bubble of a long fermentation in the world” -George Santayana

Factors affecting the design of fermenter
The design and mode of operation of a fermenter mainly depends on the production organism, the optimal operating condition required for target product formation, product value and scale of production. The choice of microorganisms is diverse to be used in the fermentation studies.

The basic points of consideration while designing a fermenter:

• Productivity and yield.
• Fermenter operability and reliability.
• Optimal Water requirements for processes.
• Optimal Energy requirements.
• Capital and operating costs
• Potential for fermenter scale-up

Basic Fermentation Process Requirement Criterias:

• Hydrodynamic characteristics of the Fermenter bioreactor
• Mass and heat transfer characteristics of the Fermenter/bioreactor
• Aseptic equipment design
• Control of fermenter/ bioreactor environment (both macro and micro-environment)
• Implications of bioreactor design on downstream products separation

Fermenter/ Bioreactor manufacturers need to be sensitive/ serious on these aspects. Lack of attention on these may lead to unhealthy process conditions leading to low quality &/or quantity of desire products.

We @ PHS have learnt to discuss, study & understand user process & design requirements in depth and include them at very early stage of Fermenter designing. The need to understand the process without infringing on the client’s IP is REAL and needs to be approached differently. Equally important is to focus on plant integration and handshake with third-party equipment like centrifuge, TFF’s, High Pressure Homogeniser etc.

Think Industrial Fermenters, Think PRAJ HIPURITY!!

Topic Covered: Electropolishing (History, Know How, Effects & Application)

As we are part of the Pharma & Biotech Industry we often refer to electropolishing in our day to day discussions for equipment & components used in the systems used for handling, storage, transporting & distribution of critical products.

This Blog is aimed to provide the readership with insightful understanding of the electropolishing process, its fundamentals and its application.

History of Electropolishing

In 1912 when Imperial German Government issued a patent for finishing of silver in a cyanide solution, electropolishing process was invented.

Lots of efforts were put in the years to come but it was year 1936/37 when Dr, Charles Faust and his team discovered solutions for electropolishing Stainless and other metals.

So What is Electropolishing?

Electropolishing is the electrochemical process to remove the metallic material from the workpiece, in order to obtain a smoother metal surface; it basically streamlines the microscopic surface of a metal object. If defined in simple words its reverse of plating.

So why Electropolishing is done?

In addition to design and the choice of material, the quality of surface finish has a decisive effect on the function & performance of the component service life and effectiveness.

The treatment of metal surface therefore determines the suitability, performance and the operating cost.

What are the effects of Electropolishing on Metal?

Basically there are two types of Effects, Macroscopic & Microscopic.

Macroscopic Effect: As the electropolishing process starts, the concentration of electric field at edges and protrusions of the work piece locally creates higher current densities which increases the removal rates which is useful for removing the macroscopic burrs or in simple words we can say fine de-burring of the work piece.

Microscopic Effect: Post the Macroscopic Effects starts the Microscopic effect, In this a thin layer of polishing film is formed at the surface of the work piece , it removes the micro level roughness of the surface of the work piece creating a smooth and polished finish of the surface.

Applications:

Today electropolishing is successfully applied to an expandable range of new applications. Major benefits of electropolishing is successfully continued to be demonstrated in Reactor vessels, Process Equipment, Bioreactors, Heat Exchangers, Storage Tanks, Piping and Tubing, F & B Processing Equipment, etc.