Outsourcing production of injectable ampoules

Edited by the Processingtalk editorial team Oct 5, 2007

If a production line becomes incapable of delivering products that meet new regulatory requirements, it is difficult for pharmaceutical companies to justify the investment to upgrade or replace it

Therefore, outsourcing the production of injectable ampoules to a specialist contractor is viewed as the most efficient and cost-effective solution for pharmaceutical companies wishing to offer fully compliant products at the minimum possible cost.

Contract manufacturer, Cenexi, builds a case to justify outsourcing production and to help choose the right contractor.

It has been estimated that pharmaceutical companies would need to invest around euro10 million in order to install the new or upgraded injectable ampoule production lines now needed.

With the global contract manufacturing market expected to exceed $26bn by 2011, it is important for contract manufacturers to offer innovative, real-time services to stay ahead of the competition.

The cleanliness of the manufacturing site must always be of the highest quality, ensuring constant sterility of the water and air-conditioning system, that personnel wear protective clothing at all times and that the machines are constantly turned on even at weekends and holidays.

All equipment must also be sterilised prior to contact with the ampoules.

These processes are put in place to reduce the risk of contamination from dust particles and dirt.

By taking all these safety measures, class C cleanliness is achieved.

Such a high level of cleanliness is very expensive to maintain thus increasing the running costs of the plant.

This considerable financial burden is therefore lifted from pharmaceutical companies who outsource their ampoule production, thus freeing up funds and production space, that can be diverted for higher margin products.

Additionally, regulations require that no impurities be found in ampoules.

Therefore, a high standard quality control process must be established.

This is an additional cost burden to pharmaceutical companies.

At Cenexi, expensive optical inspection equipment is employed that allows the detection of three main non-conformities, while a separate, random check is carried out at the end of the line by a member of staff.

Cenexi uses a pinhole detection machine for ampoules and vials that features a high voltage electrical field, and impedance measurement to examine each container at four inspection points, for hairline fissures and pinholes, leaking ampoule neck tips, insufficient glass thickness at the tip and absence of fill.

The machines are very expensive, using the latest in high frequency, high voltage technology ensuring the reliable, accurate and non-destructive inspection required to comply with rigorous, strict industry standards for high-quality, safe products.

Another advantage when transferring production to a contract supplier is that the existing production line can remain in use while work is processed, in order to establish and validate the contractor facilities.

This helps minimise the risk of supply interruptions.

An alternative solution for the pharmaceutical company would be to build up large stocks of certain drugs, but this approach is costly, inconvenient and in the case of short-lived products it may even be impossible.

Cenexi offers a complete solution from manufacturing to delivery as well as employing a dedicated team who deals with the regulation requirement registrations of injectable ampoules worldwide.

Pharmaceutical companies outsourcing their ampoule production to Cenexi will be able to focus on the market, letting a reliable and resourceful partner take care of their supply needs.