F.F.P. Department was established in 2005 for Formulation, Filling and Packaging of recombinant products in two separated floor of production plant.

The F.F.P. Department produces following products:

• Hepatitis B vaccine
• PastoCovac vaccine
• PastoCovac Plus vaccine
• Contract Manufacturing with other producers in 3^rd floor
• Animal Rabies Vaccine

F.F.P. Main Units:

• Material and Solution Preparation Unit
  • Preparation and sterilization of required materials for formulation and filling units, e.g. solutions, siphons, filtration system, gown, rubber, cap, etc.
  • Preparation of disinfectant material for cleaning of the clean room is other duties of this unit.

• Formulation Unit
  • Preparation of the equipments (chemical treatment, CIP, SIP the tanks of formulation system).
  • Preparation of the buffer solution.
  • Preparation of the preservative, stabilizer, and other additives.
  • Preparation of the adjuvant.
  • Aseptic formulation process.
  • Filtration and sampling of the final Lot.

• Vials Washing and Filling Unit
  • Cleaning the inside and outside of the containers by washing by PW and WFI and pressurized process air.
  •  Depyrogenation of the vials by dry hot air and cooling down.
  • For liquid products, filled vials closed by rubber stopper and then sealed by aluminum cap to prevent interring any particle or contamination.
  •  For lyophilized products half vials stoppering is done, and these vials transferred to the lyophilizer in trays. After lyophilization process ends, vials transferred to the filling machine to be sealed by aluminum cap. 

• Lyophilization Unit
  • Physicochemical drying process designed to remove solvents from both aqueous and non-aqueous systems, by sublimation and desorption.

• Visual Inspection Unit
  • Inspection of all filled vials by trained operators and machines for the presence of any visible defects, such as strenuous particle, CAP deformities, volume, etc.
  • Segregation of the rejected vials.
  • Process control, according to the batch size.
  • Re-inspection of segregated rejected vials by the technician.
  • Reconciliation of the batch quantity.
  • Destruction of the rejected vials according to the related SOP.

• Labeling and Packaging Unit
  • Perform the recording of the batch number, manufacturing, expiration date and QR code on the accepted vials with the correspondent product label.
  • Stamping small or medium boxes
  • Fold the leaflet according with the format of the correspondent product.
  • Carry out the insertion of checked vial’s label inside the small box that contain the brochure and then it inside the medium boxes.
  • Control the weight of all medium boxes.
  • Shrink the boxes of the product according with the product’s format.
  • Inserting the shrink boxes inside big cartons.
  • Sample collection for QC by the technician.