Biopharmax: Enable operational excellence and competitive advantage

Atul Pabalkar, Sr GM Engineering and Projects, extends the views expressed by the CEO Biopuremax Shlomo Sackstein about holistic measures which should be taken to ensure that all system function as one entity

More and more businesses these days are beginning to understand the importance of holistic approach, or in other words, total system analysis. Especially in complex systems such as pharmaceutical manufacturing facilities, looking at the big picture and knowing that all the systems have to function as one entity, is crucial for success. Biopharmax has had this approach from the start, insisting on a turnkey method, focussing on the way all the system components interrelate and how they work within the context of the larger system.

Holistic approach

• Viewing and treating a complex systems as one entity.
• Looking at the big picture, considering the entire process rather than specific components Thinking ‘outside of the box,’ not being afraid to make substantial changes
• Develop entirely new mindsets and solutions to problems
• Dramatic improvements to take optimise functionality
• Making sure the system reaches its full potential as a whole, rather than having strong areas and weak areas

Turnkey projects

• One of the biggest advantages of turnkey projects is being able to integrate subsystems into the total system
• Old fashioned way: Execute each part of the project separately, which limits the options needed to optimise the system as a whole
• Turnkey: Streamlines the entire process of fitting all the components together for ideal integration
• Responsibility for project success by meeting present criterion
• Allows flexibility and customisation to client needs

Biopharmax Water System

• The development of Biopuremax process is a perfect example of holistic approach
• Rather than accepting the current drawbacks of water purification systems, the former CEO of Biopharmax invented a first-of-its-kind solution which includes an ESR (Electrolytic Scale Reducer) and a HOD (Hydro Optic De-Chlorination), which in combination, maximise all water performance criteria: high reliability, low maintenance, low bacteria, low operational costs, no regenerations, no chemicals, no organic media.
• Resulting in substantial low life cycle costs and low environmental foot print.

Open-minded clients

• It is not enough for the contractor to have an holistic approach, as few clients are able to approach a problem ‘open minded’
• In many cases, the client requests to repair or replace a specific component that creates a bottle-neck only resulting in a new bottle-neck in a different part of the system.
• Therefore, it is crucial to find the root of the problem and look at the system as a whole, often improving the entire process and saving costs of future maintenance and repairs.

Constant maintenance, is it really inevitable?

It can be avoided!

A client owning an existing vaccination production facility has contacted Biopharmax reporting unreliable final product.

Identified problem

Even though the final product seems to be clean according to standards, the reality was that the entire process was contaminated. Only thanks to the RO, the final product was clean enough. There was a bacterial breakthrough and the system was taken off line before sanitisation.

Why is this not good enough?

• Inefficient commonly used water purification systems create microbial build up and microorganism proliferation in softeners. These microbes were fed directly to the reverse osmosis membranes and caused surface contamination and fouling of those membranes with impact on product water and operational parameters.
• As a result, constant maintenance was required, having to stop the system for rigorous cleaning and possibly having to replace the system components at some point.

Solution offered

• Holistic view of the problem, looking at the big picture and identifying the true problem: contamination throughout the entire process.
• Biopuremax system, including ESR and HOD
• The solution is proven to save costs of: maintenance, new parts and much more reliable than all the other solutions in the market.

I identified the bottle-neck, now I can solve the problem

Not necessarily. Solving one bottleneck can create a new bottleneck.

Existing state and client reported problem

• Distillation process for hot WFI production, storing the water at 90OC and cooling it before use. Water cooling process is too slow, creating a holdup in the production schedule.

What is the real problem?

1. After analysing the system as a whole, it was identified that:

• Heat exchanger are too small
• 93 per cent of WFI is used cold
• In addition to insufficient cooling capacity, the WFI storage tank was always at critical low level.

Options for solution?

Increasing the size of the cooling system – will solve the cooling bottleneck, but will come up against a new bottle neck in production capacity because of low levels of WFI in the tank.

Recommended solution: Split the WFI system into hot and cold systems. The existing system will continue to supply the hot consumers, and a new cold generation with cold storage will supply the cold users. In this way, energy savings are maximised, no new cooling or heating utilities are needed, and the system pays itself back with a year due to infrastructure and ongoing energy savings.