In the field of injectables, quality is a question of ethics on a daily basis
The production of products destined for the pharma industry is controlled by strict regulations defined by government bodies such as the Food and Drug Administration and the European Medicines Agency through Good Pharmaceutical Manufacturing Practices.
The regulations lay down precise recommendations to guarantee quality, safety, integrity and drug purity. They concern the totality of the production line, the manufacturing site premises, machines, equipment and also the entire staff.
Guaranteed traceability at each step in the manufacturing process
Our production undergoes validations and inspections throughout the whole process. Our in-house laboratory allows us to guarantee the level of compliance required by our customers and by the ISO 15747 standard:
- Microbiological (Bioburden, LAL)
- Physicochemical (RI, UV, MFI, etc.)
- Integrity (pressures, drop tests, etc.)
Technoflex is committed to permanent quality improvement and ensures that the references such as the ISO 15378 standard are applied on a daily basis to incorporate the GMPs applicable to primary packaging in our ISO 9001 Quality Management System.
Certifications
ISO 9001:2015 | Certificate
ISO 15378:2017 | Certificate
Inerta®: US DMF # 19057 | Canada DMF # 2007-070
SafeCell®: US DMF # 032647
Dual-Mix®: US DMF # pending
