BCB MT

BCB was founded in 2008 to introduce its rooster comb extract based Sodium Hyaluronate substanced products which are used in Ophthalmology, Orthopedics, Dermatology, Urology, Gynecology, Plastic and Reconstructive Surgery, General Surgery, Orthodontics and Oncology branches by the technology transfer from the best known country for its excellence in Pharmacology, Pharmaceutical and R&D; Sweden.

Continuing its projects in the R&D laboratories with the internationally known process and raw material manufacturers, BCB cooperates with leader suppliers of international arena and continues its high quality production with an huge investment.

Our priority in Quality Management is to follow a “Zero Mistake” strategy in our evaluations, progress, choice of raw material and supplier without making any concessions and we suggest our suppliers to upgrade their quality standards to our well-defined and extensive quality expectations.

Quality is the key to the economic success of our firm. Our definition of ‘quality’ states that quality is not an outcome of ‘control’, on the contrary it is an outcome of adopting a responsible and disciplined attitude, optimal planning and international standards mentality to production.

Our production is realized in Aseptic conditions, fulfilling the ISO standards.

Although the production processes are done in aseptic conditions, we take a second sterilization step to be on the safe side and apply Steam Sterilization, due to our “Zero Mistake” policy.

Our production is done in three clean rooms satisfying ISO 14644 standards; ISO 5, ISO 6 and ISO 7 rooms.

The syringe filling line in ISO 6 room is designed and set by the German firm Groninger (certificated in FDA and ISO standards) and the high viscosity preparates are filled into syringes to be bubble free under vacuum at a rate of 2.450-Ad/0.85ml syringe per hour. Low viscosity preparates are filled at a rate of 4.550-Ad/0.85ml syringe per hour. Filling line is covered by a Laminar Flow Unit (ISO 4) which provides the zero (0) particle environment and the safety of the room is controlled by using a particle meter throughout the filling process and noting the conditions.

Another crucial machine in ISO 6 room is the Pharmaceutical Steam Sterilization machine which is manufactured privately in Switzerland by Fedegari Autoklaven AG. Since our raw material; Sodium Hyaluronate, is especially sensitive to high temperatures (121°C), the performance of the sterilizator is fundamental. For this reason some global Sodium Hyaluronate producers apply Aseptic Production Conditions and label their products as [STERILE A] to guarantee that the product is sterile.

Even though the entire production is done under Aseptic Conditions in BCB, all products are put through steam sterilization to eliminate any risks that may arise due to human conditions or violation of aseptic conditions.

Also the Pharmaceutical mix reactor which is manufactured by the Swiss ESCO-LABOR is an important component of our production line.

Besides the tests that we do at all steps and at the end of our production, we work with a third part laboratory in Sweden to get an objective and certain lab result through which our samples are subjected to 18 separate tests in 20 days as stated in European Pharmacopeia. The products which are stated to be acceptable according to the European Pharmacopeia criteria are released.