To Meet Pharmaceutical Requirements
Quality is the major focus of sites manufacturing pharmaceutical bottles. Conscious that the patient is the final user of our products, Saint-Gobain Desjonquères lives by the highest and strictest quality standards.
Quality System
All our manufacturing sites for pharmaceuticals bottles are certified ISO 9001,version 2000.
In every facility,our staff is fully committed to respecting applicable c-GMP’s to ensure the highest sustainable quality for the pharmaceutical market.Saint-Gobain Desjonquères is partnering with its clients to tailor quality
specifications.
Our brand new corporate program based on systematic customer feed back is witness of a clear proof of the dedication of Saint-Gobain Desjonquères team to provide the best quality level feedback of service to its pharmaceutical clients.
Product Quality
In agreement with their customers, SGD is setting up a proactive specific “quality contract” adapted to their needs and requirements.The traceability of the production is maintained through a computerized system of all composition analysis results. Controls carried out and
acceptance limits are described in our standard specifications, available in several languages.
Inspection
In all its factories, Saint-Gobain Desjonquères developed fully automated inspection systems – from the initial composition of raw material to the final packaging. On-line inspection systems check 100 % of the bottles for dimensional, functional and visual aspects. A broad variety of physical-chemical tests are performed to validate the
composition of each product batch. Additionally, for every production batch of bottles and for each type of glass, hydrolytic resistance tests are conducted to assess and validate the stability of the final product.
Regulatory Support
SGD works in collaboration with its clients providing them with all the requested documentation for quick approval and registration of their products with the Regulatory
agency (Drug Master Files registered at the FDA and
quality certificates for each delivery etc…).
A Pioneer in Clean Processes
Since 1993, Saint-Gobain Desjonquères has been the first glass maker to be equipped with class 100,000/ISO 8 clean rooms. This performance is achieved in rooms over 10,000 sqm, after the annealing process. On-line automated inspection systems and shrink-pack packaging are performed in overpressured and controlled air facilities.
Air Locks are used for staff and material to transit. The staff is appropriately trained and dressed.
The level of particles and bacteriological quality of vials are strictly and constantly monitored.
