Continuous coating firm eyes Europe
world's only dedicated continuous coating machine for
pharmaceutical tablets.
After being launched last year, the company already has one customer using the machine in the US and three other multinational pharma companies expressing interest, however, the firm is now also trying to attract the attention of European drug manufacturers also.
According to O'Hara, the continuous coating process allowed by the machine can eliminate or substantially reduce waste associated with start-up and shut-down; allow for a one to three pre cent weight gain on demand and allow for an operation range from 700-2,000kgs/hour.
In addition it has WIP/CIP capabilities, a quick product or batch change turn around time and also provides recipe capabilities, said the firm.
"The current model is a large scale version - the company that is currently using it is producing 5,000kg batches - but we are soon developing a smaller capacity model too," O'Hara spokesperson Jim Marjeram told In-PharmaTechnologist.com.
The concept of continuous processing is only starting to catch the eye of the pharma industry as process analytical technology (PAT) gains in popularity amongst drug manufactures, who are constantly looking for ways to improve processing efficiencies and costs.
The FDA has also actively been urging the pharmaceutical industry to embrace PAT in an attempt to modernise, publishing guidelines for PAT as part of its 21st Century Initiative.
"The industry is moving towards using these technologies more but a whole regimen change will have to occur and manufacturers will have to go through a period of adaptation first," said Marjeram.
There are also a few specific hurdles before continuous systems such as our coating machine are more widely adopted by the industry, such as a clarification on how a batch is defined for quality control purposes, he explained.
"For example, a batch could be based according to a certain product quantity or a certain time frame, but the concept still needs to be developed."
