At Balkan Pharmaceuticals®, the air, water, surfaces, materials for the production process and even production and management personnel undergo the most thorough of filtering, cleaning, and testing to ensure the lowest possible levels of potential contaminants and highest possible levels of quality control. Any materials of questionable integrity are excluded from the clean rooms.

Preparation of Materials

Water entering the facility undergoes intensive purification, whether used for pharmaceutical manufacturing or for a pail of ordinary mop water. In part, this is to reduce or eliminate biological contamination of our facility and in part to ensure that unwanted potentially active agents such as chlorine and fluoride are excluded from the pharmaceutical preparation environments. Bulk materials for the production process are put through similarly stringent sterilization to ensure that no contaminants get into the production process.

Personnel entering the clean room facility undergo showering and intensive sterilization. Additionally, each person entering passes through an “air shower.” An air shower is a small chamber, about one square meter in floor space, that forces high pressure air around the subject to eliminate any dust or other foreign particles from their clothing as a final step before entering the clean room environment.

Quality Control

Quality control begins in the clean room even before the first stage of pharmaceutical manufacturing. Water and bulk ingredients are tested and verified by 2 teams, each team inspects materials at every step of the manufacturing process with results from each team cross-referenced against the other to verify the findings at each stage. Discrepancies are documented and promptly investigated. Additional samples are forwarded to the Agency of Medicines of the Republic of Moldova for secondary verification and certification.

Air throughout the facility is filtered to prevent outside contaminants from entering the production facility and to eliminate any airborne particulates from the production process itself from cross-contaminating other production batches. This is achieved through pre-filtering of the facility air supply with G4 filters, and then supplemented with F7 and F9 filters on all main air ducts. The clean room is further protected by H13 terminal filters.

Finished Products

Finished products are carefully packaged in a variety of market standard sizes and in strengths approved and certified by the Agency of Medicines. Quantitative controls are stringent on both our injectable and tablet pharmaceutical lines and are under a constant quality monitoring.

Prior to release to our product storage facility, representative samples of the finished products are selected and tested using state-of-the-art equipment to ensure consistency and stability, again with representative samples being sent for verification of their quality by the Agency of Medicines of the Republic of Moldova.