Cenexi adds fifth ampoule filling line

Cenexi, the contract manufacturing member of Roche Pharmaceuticals, is installing a fifth ampoule filling line at its Fontenay sous Bois facility on the outskirts of Paris.

The company specialises in the outsourced manufacture of injectables delivered via ampoules, as well as tablets, syrups and suppositories.

The new ampoule line extends the company's manufacturing capacity while broadening its scope by enabling DIN standard ampoules to be produced alongside the Roche standard sizes. It also extends the company's capability to make larger dosages by allowing 10ml to 20ml sizes to be made alongside the 1ml to 6ml ampoules of the existing four lines.

Outsourced manufacturing for 20ml size ampoules is very difficult to find, the company says, and it anticipates finding high demand from smaller pharmaceutical companies for this capacity.

Equipment has been transferred from Roche's Mannheim site and includes Bosch Boehringer equipment as well as Bausch & Strobel lines that have been checked and refurbished by the company. The factory acceptance tests were completed in May 2004 while the site acceptance tests were carried out between May and September 2005.

Validation batches have been started and the performance qualification (PQ) on the first product to be produced on the line will be completed shortly, with two further products qualified by the early 2006. The line is expected to be in full production by spring 2006.

The first three products destined for the new line is a water for injections, a stimulant and an anaesthetic. These will be produced in 10ml ampoules in volumes from 2.5 million to 7.8 million a year each. Total capacity of the line is 30 million ampoules a year.

One advantage claimed by Cenexi is rapid transfer of products to the new line. Typically validation and product transfer takes up to two years, whereas the company says it has been able to truncate the process to less than six months in many cases.