Our plastic ampoule contract manufacturing service

CDM Lavoisier has been manufacturing drug products since 1888. Then, CDM Lavoisier adopted the BFS technology in the 2000s in order to offer part of its product range in this type of container. The transposition of these drugs from glass to plastic required several years of development work to adapt the formulation, the filling process and finally the sterilization cycle of these drugs to the constraints of plastic.

This know-how has enabled CDM Lavoisier to position itself as a recognized player in plastic ampoule manufacturing in Europe. Today, our BFS filling lines are available to many stakeholders and pharmaceutical companies to manufacture their drug products. Our facility is GMP certified and regularly inspected by the ANSM (French healthcare industry control authority) and audited by the GMED.

Thus, as a BFS CDMO, we comply with the highest standards for injectable and sterile manufacturing. We never compromise on product quality.

With two manufacturing lines for single-dose BFS ampoules and a filling capacity of 0.4 to 20 mL, CDM Lavoisier has a particularly flexible tool, sized to meet the growing needs for injectable BFS ampoules.

Our production capacity is more than 30 million small volume units per year on two recent filling lines. This will allow us to fill the following volumes :

• 0.4 mL ;
• 5 mL ;
• 10 mL ;
• 20 mL.

Other volumes are possible with the development of a specific mold adapted to our BFS equipment.

As a BFS manufacturer, CDM Lavoisier masters the whole manufacturing chain of a drug or medical device in plastic ampoule :

• Procurement of components and raw materials ;
• Quality control of these components and raw materials ;
• Solution preparation ;
• Sterilizing filtration ;
• Molding of the BFS ampoule (primary container) ;
• Ampoule filling and sealing ;
• Terminal sterilization with overheated water ;
• Quality control during production and of the finished product;
• 100% visual inspection ;
• 100% automatic integrity check (leak detection) ;
• Ampoules packaging in bulk or in boxes ;
• Analytical testing and batch release.

But our expertise is not limited to BFS contract manufacturing. We offer comprehensive end-to-end support, guiding your drug product from formulation development to industrialization.

The BFS technology is a real innovation which consists in manufacturing an ampoule directly from plastic granules. The BFS operation is as follows :

• Thousands of polypropylene polymer pellets are sucked in and heated at high temperature to melt them ;
• The melted plastic is then blown into a mold ;
• A needle goes down into the ampoule thus formed to fill it with the sterile solution ;
• The ampoule is finally closed.

This operation takes only a few seconds and guarantees a high level of product sterility.

CDM Lavoisier manufactures on its BFS lines products for other pharmaceutical companies, but also its own products. In addition to our industrial know-how, we have mastered the process of registering a drug with the health authorities, as well as the ability to operate and distribute products on the French market on behalf of third-party laboratories. Thus, a pharmaceutical company wishing to establish itself on the French market can subcontract the manufacturing of its products to us, as well as their registration and distribution.

More and more products are evolving their pharmaceutical form from a rigid to a flexible dosage form. There are several reasons for this industry-wide movement :

• Glass containers are often more expensive to manufacture than plastic containers ;
• Plastic is much lighter than glass, which reduces transportation costs ;
• A BFS machine has a greater hourly production speed ;
• Compared to glass ampoules, the BFS process offers a lower risk of contamination ;
• During ampoule opening, no glass particles could fall into the solution ;
• Finally, plastic is less fragile and less likely to break than glass.

Container-content interaction studies are used to evaluate the compatibility of these containers and the possible risks of migration.