Is the API’s and Intermediates industry in India going towards Automation?

With the current COVID-19 situation worldwide panning out as it is, the entire pharmaceutical industry is in a rethink about business continuity and dependency costs of labour. And the engineering industry is currently in a flux of offering customized complete automation solutions to their clients.

The benefits of automation are well-known but have always been overshadowed by the cost component of automation. Considering the Indian conditions, a 100% automation strategy might not be the right way to go. A customized product-centric approach is a right way to go.

The API’s and Intermediates manufacturing in India has always been a relatively humanized operation and not without fair reason. The main reasons for the lower degree of automation or instrumentation can be chalked out to the following:

  • The markets for the API’s and Intermediates are extremely dynamic leading to frequent product changeovers.
  • Very few indigenous automation system providers who can offer end-to-end solutions catering to pharmaceuticals
  • Relatively cheap labour
  • Know-how deficit in the labour force leading to an approach where “as seen before” is considered the safer way.

Automation in API or Intermediate facilities can be divided into the following areas:

1)Raw-material/solvent addition or charging

This would involve the addition of liquid raw material/solvents in measured quantities as well as solid raw materials in measured quantities. Automated mass flow meters with interlocks is one way of achieving the required accuracy, this process, however, is done efficiently by means of additional vessels. Deciding on this kind of automation is dependent more on the accuracy requirement of the liquids. For solids generally in the API/Intermediate domain, the additional quantities are generally small for automatic bag slitting and transfer operations to be economical. This can still be done in situations where hazardous solids are to be added.

2)In process automation

This phase of automation is generally practised in India as well with multiple interlocks for reactions based on temperature, pressure or reaction end-points. It is essential to decide on the instrumentation and automation strategy based on product value and reaction tolerances.

3)Wet-cake handling

This area of automation is not explored in a big way in India and this seems to be the missing piece to obtain labour efficiency. Post centrifugation solid handling in API/ Intermediates is a laborious activity and can be effectively reduced drastically by indigenous automation solutions. The entire activity from centrifugation wet cake handling, to drying and powder processing, can be automated to minimize labour dependency.

4)Filling

Packing and filling as the final step is done automatically in a lot of companies. This leads to human error in the weight of bags in spite of weight checks. This could lead to substantial uncalculated product loss over a period of time. Systems with loss in weight feeding are now available with extremely high accuracies to fill bags, drums or other containers to counteract this problem.

Cost-benefit analysis for wet cake handling and filling operations:

Labour requirement without automation:

  1. Total number of labour required/ shift in wet cake handling -10
  2. Total number of labour required/ shift for filling operations-3
  3. Total labor requirement for three shift manufacturing -13x 3 = 39

Labour requirement with automation:

  1. Total number of labour required/ shift in wet cake handling -2
  2. Total number of labour required/ shift for filling operations-2
  3. Total labor requirement for three-shift manufacturing -4×3 = 12

Overall labour reduction:27

Approximate cost of complete automation system: Rs. 1,00,00,000/

Average annual approx. labour cost/labour including unskilled and semi-skilled for the difference in labour requirement(27 labourer’s): Rs. 32,00,000/-

This warrants a payback period of little over three(3) years.

This is a clear indication that indigenous automation systems have brought the payback periods to reasonable timelines. The current analysis does not consider product loss or overfilling loss caused by human error which would reduce the payback period further. Additionally, there are multiple qualitative benefits in terms of reduced human contact for cGMP, consistent operations and accuracies in-built in an automatic system.

In conclusion, with the current dearth of labour and to avoid further dependencies and to ensure business continuity, there is a definite need for a rethink and movement towards automation in API and intermediate manufacturing to ensure a clean, consistent work environment.

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