State-of-the-art drug manufacturing plant ready to make a difference | Print edition

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The compression machine (D tooling 17 Station) which is used in the tablet compression stage

By Kumudini Hettiarachchi

Sporting an exterior of eye-pleasing white, sunny yellow and ash gray tones, in a rectangular building in the Nanotechnology & Science Park set amidst pastoral scenes in Pitipana, Homagama, the wheels of silver machines turn silently – producing stocks of medicines in tablet and liquid form.

Aimed to make a difference, not only in the lives of the men, women and children of Sri Lanka who are cash-strapped and facing numerous drug shortages, but also nationwide, it is the center of Morison Ltd.’s state-of-the-art pharmaceutical research and manufacturing facility. , a subsidiary of Hemas Holdings PLC. This center is ideally located next to the Sri Lanka Institute of Nanotechnology (SLINTEC) with which he hopes to have many research collaborations.

Donning sterilized caps, face masks, robes and boots with a change of outfit in between and looking like aliens from outer space, we walk along the halls of the center looking through glass doors of the machines sophisticated plants producing a much-needed infusion of medicine to a country that sorely needs it.

It’s a first.

“This is the first and largest general ‘oral solid dose’ (tablets) manufacturing facility built to international standards and specifications in Sri Lanka,” says Morison Ltd. Managing Director Dinesh Athapaththu, highlighting that another first is that it is a zero liquid effluent discharge station.

The bottle filling machine along liquid filling production. Photo by MA Pushpa Kumara

The factory’s full capacity is five billion tablets per year when it begins operating in two shifts per day. Currently, only one team operates to produce paracetamol 500mg (for fever and mild to moderate pain) and chlorphenamine (used to relieve allergy symptoms) as an oral solution.

Sri Lanka’s national drug requirement of $600 million (Rs 240 billion) covers both public and private sector, local manufacturers including the State Pharmaceuticals Manufacturing Corporation (SPMC) , reaching about 15% of this value.

Among local private sector drug manufacturers, Morison Ltd. holds a relatively large share, we learn.

Unlike India, Pakistan and Bangladesh, which have been manufacturing their pharmaceuticals since the 1950s and are now self-sufficient, Sri Lanka is still heavily dependent on imports.

This pharmaceutical manufacturing and research center has been built and equipped with a huge investment of Rs. 4 billion with not only National Medicines Regulatory Authority (NMRA) approvals but in accordance with international standards maintained in the countries of the European Union (EU). The factory is in the process of obtaining international accreditation, which would take about two years, it seems.

The state-of-the-art white, yellow and ash gray plant producing medicinal tablets and liquids for Sri Lanka

“We set out to take our manufacturing to the next level,” is Mr. Athapaththu’s simple explanation. For, government ‘buy-back’ assurances in 2015 (for about 80 drugs) for local pharmaceutical companies that were manufacturing, were working well in 2015. The Mutuwal factory in Morison had also reached full capacity in 2017.

So Morison Ltd. built this new center for the purpose of exporting its pharmaceuticals, hopefully. Teams from Morison had traveled to India to examine a country that is a thriving drug manufacturer and, without cutting corners, also hired a large firm to advise them on how to construct the building from the foundation and equipping it with all the latest technology geared towards the EU as a guide.

Mr Athapaththu says that from machine layout, quality management systems to training local staff to be meticulous about doing things right and maintaining those standards, Morison Ltd. hired a high-level foreign team.

“We had been in drug manufacturing for a long time, but we hadn’t had enough exposure to very high quality standards, including the calibration of machinery,” he says, reiterating that staff have gained in-depth knowledge. and training in the use of sophisticated machinery as well as international quality management systems.

Built in 2018, the Pharmaceutical Manufacturing and Research Center had been opened in 2020 for validation, with commercial manufacturing rolling out of the machines in May this year (2022).

The dissolution apparatus in the quality control laboratory

The fascinating walk the Sunday Times team across the factory takes place with Mr. Athapaththu; Senior Director (Strategy and Analytics) Rukshani Perera; Senior Manager (Quality Assurance) Jayani Adikaram; and director (production) Arun Divahar.

The factory hallways’ epoxy flooring is blue with no plinth where it joins the modular panel walls. This flooring inhibits microbial growth and, like walls, makes cleaning easier.

Minute details have been considered – from when the raw material, including active pharmaceutical ingredients (APIs) and pharmaceutical excipients (included in drugs to facilitate the manufacturing process and to protect, support or enhance the stability), mainly from India and China, is brought to the plant. They are dusted, cleaned and the quality of each sample is checked and stored for distribution or discarded if it does not meet the required specifications. The receiving channel and the raw material distribution channel are separated to avoid the slightest possibility of contamination.

As the plant has different manufacturing suites, there are separate air handling units for each, with outward (inside out) airflow, so that external pollutants cannot cause any problems. It is also to nip potential product failure in the bud by trapping air in that particular unit to prevent contamination of other areas.

The manufacturing process differs depending on whether the drug eventually emerges as a tablet or a liquid.

  • For tablets, the process covers granulation, lubrication/mixing and compression, with coating being a further step if required. Once manufactured, the packaging would be either in bulk or in blister packs.
  • For liquids – the process is manufacturing, filling bottles and packaging.

The team takes great pride in the rigorous checks carried out at every stage – quality checks, chemical parameter checks and more. Each batch also has specific details to trace back to the beginning, should the need arise. Not only does it just put the stocks on the market, but post-market surveillance is also mandatory.

With the hope of intensive research and development of ‘new’ and also ‘niche’ products, Mr. Athapaththu adds: “We want to make quality health care affordable for all Sri Lankans. We are also looking to produce a “unique” Sri Lankan pharmaceutical brand.

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