The number of parenteral products entering development and reaching the market has increased significantly during the past decade. By some estimates as many as half of all investigational new drug applications consist of biopharmaceuticals, the vast majority of which are manufactured aseptically.
Care has been taken in the design of the aseptic processing facility to ensure that it will comply with all global regulatory requirements. Current regulatory guidelines require clinical product to have the same sterility assurance as commercial product. Therefore, the facility must be designed to provide contamination control superior to that of any staffed cleanroom and to achieve near-zero contamination results in environmental monitoring and media-fill testing. The validation and process control programs are of the same standard as would be applied to a commercial aseptic processing facility.
Pharmaceutical vial filling machines perform a critical function in the pharmaceutical production chain: they ensure volumetric consistency, reduce product loss, and feature built in quality control in the form of volume checking.
Key purchasing considerations for pharmaceutical vial filling machines include the predicted vial filling production output (e.g., hundreds of vials per minute), the filling range of the vials, and desired fill accuracy.
The Rising of a player: i-Dositecno
i-Dositecno is a company dedicated to the developing and manufacturing of filling systems for the pharmaceutical industry. Headquarters are located in Barcelona, a great environment for growth as well as achieving the greatest quality and design standards.
In 10 years, i-Dositecno has achieved a high technological specialization, in which engineering and creativity are brought together to bring customers the best solutions in filling systems. With a great team of highly qualified professionals, Knowledge is the basis for their success.
Since their beginnings, a great variety of machinery has been developed, reaching the pharmaceutical industry with remarkable products: completely servo-motorized machines, engineered to ease and improve format changing and optimize production. These machines are on the forefront of technology and Scada software design according to the 21CFR Norm part 11.
The company design and build sterile and aseptic filling machinery for the pharmaceutical industry, suited for oncology, biotechnology, biosimilars and ophthalmological products.
A unique characteristic of the company is i-Dositecno Lab: the staff is the basis of their success and the future development of the company, allowing them to implement new technologies and high-quality equipment.
Teamwork in a cooperative atmosphere, satisfaction, responsibility and predisposition to make decisions are key foundations to the strategy of i-Dositecno. This generates the perfect environment to place the customer as top priority, providing the best customer service in the industry with a 24 hours year-round response rate.
At LyophilizationWorld we are proud to promote i-Dositecno team and product and we believe they are climbing to the top of filling machine manufacturer circle.