Escape cost and hassle

Personnel must wear protective clothing at all times.

As a production line ages, it becomes incapable of delivering products that meet current regulatory requirements. However, it is difficult for many pharmaceutical companies to justify the huge investment needed to upgrade or replace it. Outsourcing the production of injectable ampoules to a specialist contractor is one of the most efficient and cost-effective solutions.

It has been estimated that pharmaceutical companies would need to invest around E10 million to install a new or upgraded injectable ampoules production line. With the global contract manufacturing market expected to exceed $26 billion by 2011, it is important for contract manufacturers to offer innovative, real-time services to stay ahead of the competition.

Saving expenses
The cleanliness of the manufacturing site should always be of the highest
quality, ensuring constant sterility of the water and air-conditioning system. Personnel must wear protective clothing at all times and the machines have to be kept on, even during weekends and holidays. All equipment must be sterilised before it comes into contact with the ampoules.

These processes reduce the risk of contamination from dust particles and dirt.

By taking all these safety measures, a class-C cleanliness is achieved. Such a high level of cleanliness is extremely expensive to maintain, and increases the running costs of the plant.

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

Strict regulations
Regulations require that no impurities should be found in ampoules, which means a high-standard, quality-control process must be established. This is an additional cost for pharmaceutical companies. At Cenexi, expensive optical inspection equipment is used to check for three main nonconformities while a member of staff carries out random inspections at the end of the line.

Cenexi employs a pinhole detection machine for ampoules and vials. The machine uses a high-voltage electrical field and impedance measurement to examine each container at four inspection points, checking for hairline fissures and pinholes, leaking ampoule neck tips, insufficient glass thickness at the tip and absence of fill. Such machines are very expensive, employing the latest in high-frequency, high-voltage technology. They ensure the reliable, accurate and non-destructive inspection required to comply with rigorous industry standards for high-quality and safe products.

Another advantage of transferring production to a contract supplier is that the existing production line can remain in use while work is processed, establishing and validating the contractor’s facilities. This helps minimise the risk of supply interruptions. Without a contract supplier, the pharmaceutical company would have to build up large stocks of certain drugs, which is costly, inconvenient and, in the case of short-lived products, may even be impossible.

Cenexi offers a complete solution from manufacturing to delivery as well as employing a dedicated team to deal with registrations of injectable ampoules worldwide. Pharmaceutical companies outsourcing their ampoule production to Cenexi can focus on the market, letting a reliable and resourceful partner take care of their supply needs.

Company profile
Cenexi is a contract manufacturer of pharmaceuticals for human and veterinary markets. Production began in 1923 with the manufacture of syrups followed by high-quality vitamins in the 1950s and benzodiazepines in the early 1960s. It now manufactures solid dosage forms and injectable ampoules for the global market.

For more information, visit www.cenexi.com.

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