Our glass ampoule manufacturing service

Our production site, located in the Centre-Val de Loire region, meets the latest standards in force in our industry, particularly European GMP and ISO 13485 standards. Our facility is regularly audited by ANSM (French National Agency for Medicines and Health Products Safety) and our various partners.

This regulatory compliance guarantees that your products can be marketed in French, European and international markets without requiring new site qualifications.

Definition of pharmaceutical contract manufacturing

Pharmaceutical contract manufacturing, or CDMO, refers to the partnership established between a pharmaceutical laboratory holding a Marketing Authorization (MA) and a specialized contract manufacturer like our organization. This model allows laboratories to entrust all or part of their industrial production to an expert partner, while retaining ownership of their formulations and regulatory responsibility for their products.

For pharma companies, using a contract manufacturer offers several strategic advantages:

• Focus on core business: free up internal resources for R&D and commercial development activities
• Investment control: avoid expenses in industrial equipment and regulatory compliance
• Production flexibility: adapt volumes to demand variations without fixed capacity constraints
• Access to expertise: benefit from the technical and regulatory know-how of a specialist

Services offered in contract manufacturing

Our service offering covers the entire value chain of your injectable products:

• Pharmaceutical development: formulation, analytical development, stability studies, method validation
• Industrial production: filling, sealing, terminal sterilization, quality control
• Secondary packaging: blister or tray packaging, cardboard boxes, package insert
• Regulatory support: CTD module writing, variation dossiers, interactions with health authorities
• Pharmaceutical distribution: marketing, supply to wholesale distributors and hospitals

Empty ampoule production stages

Ampoule manufacturing begins with the transformation of borosilicate glass tubes. The process includes several critical stages:

• The glass is heated to high temperature, then formed by blowing to obtain the ampoule body. The neck is then stretched to create the filling opening.
• An annealing treatment eliminates internal stresses in the glass, guaranteeing the mechanical resistance of the final packaging.

CDM Lavoisier sources its empty ampoules from various manufacturers in France and Europe.

Filling and sealing process

The ampoules then undergo washing and depyrogenation at high temperature to eliminate any trace of bacterial endotoxins before filling. Our production line ensures filling in a classified environment under laminar flow, in compliance with Good Manufacturing Practice (GMP) requirements.

The process is organized around the following stages:

• Solution preparation: the active ingredient and excipients are dissolved in preparation tanks under strict control of physicochemical parameters (pH, etc.).
• Sterilizing filtration: the solution passes through a 0.22 μm membrane to eliminate any microbiological contamination.
• Filling: ampoules are filled with high volumetric precision, under a controlled atmosphere to limit oxidation.
• Sealing: the ampoule neck is melted by flame, creating a hermetic seal without adding material.
• Sterilization: our products are sterilized by moist heat in an autoclave, the reference method for heat-resistant aqueous solutions. The sterilization cycle is validated according to current standards.
• Labeling: application of adhesive labels for additional information with batch number and expiration date marking.
• Packaging: trays, thermoformed blisters, cardboard boxes with package insert, meeting your distribution and use constraints.

The quality controls implemented guarantee the compliance of each batch:

• 100% automated visual inspection detecting particles, filling defects and cracks.
• Integrity control: 100% of ampoules undergo automatic leak testing.
• Sterility tests according to the European Pharmacopoeia
• Active ingredient assays by HPLC
• Physicochemical controls (pH, osmolarity, particles)
• Bacterial endotoxin tests

Glass ampoules are the packaging of choice for many therapeutic categories:

• Injectable solutions: infusion solutions, emergency drugs, local anesthetics
• Antibiotics: APIs and chemical requiring protection against humidity and oxidation
• Injectable vitamins: vitamin complexes
• Photosensitive products: solutions requiring protection from light, packaged in amber glass ampoules

Our production capacity is designed to handle products supporting terminal sterilization, with batch sizes ranging from a few thousand to several hundred thousand units.

Over the years, CDM Lavoisier has established itself as the specialist in contract manufacturing of injectable drugs in France. But our role can extend far beyond production. As each project is different, our service offer is tailored to each client’s needs:

• Registration of your MA dossier in France with ANSM and in Europe
• Management of interactions with health authorities (ANSM, HAS, CEPS, etc.)
• Development and validation of analytical methods
• Production of pilot batches, industrial batches and even clinical batches
• Distribution of your drugs to hospitals and community pharmacies

The contractual relationship we establish with our partners is based on clear reciprocal commitments:

• Confidentiality: protection of your formulations and technical data by strict non-disclosure agreements
• Quality: compliance with defined specifications and implementation of validated control plans
• Capacity: commitment to production volumes and manufacturing deadlines
• Intellectual property: guarantee of respect for your rights on developments
• Change management: formalized procedure for any modification of the process or materials

As part of your development activities, we are able to produce test batches and validation batches:

• Analytical development: we develop and validate the control methods necessary for the release of your batches: HPLC, atomic absorption spectrometry, potentiometry, UV spectrophotometry, etc.
• Stability studies: we are able to design and carry out stability studies for registration or post-MA monitoring in accordance with ICH storage conditions.

CDM Lavoisier offers the following services:

• Storage under ICH conditions
• Forced degradation studies
• Container-content interaction studies (extractables and leachables)
• Microbiology studies

Our development department establishes smooth and effective communication with your teams to coordinate the stages of your industrialization project:

• Sourcing of raw materials (active ingredients and excipients)
• Definition of the manufacturing process and terminal sterilization cycle
• Production of pilot batches (testing and registration)
• Creation of quality control methods
• Sourcing of primary and secondary packaging materials
• Adaptation of industrial equipment to meet your packaging needs