Submitted by AdmNC on Thu, 05/12/2022 - 13:41
Slides

STEP 1: Batching

  • After incoming control, raw materials are separately stored in silots.
  • Glass composition is weighed, blended and introduced in the furnace.
  • SGD Pharma produced the 3 types of glass describe in the pharmacopeia:
    • Type I: borosilicate glass, neutral in the mass
    • Type II: soda-lime glass with a high hydrolytic surface resistance
    • Type III: soda-lime glass with a low hydrolytic resistance
  • These 3 types of glass can be flint or amber.

STEP 2: Melting

  • Specially designed furnaces reach temperatures of up to 1600°C (2900° F)
  • Raw materials are converted to molten glass over a 24-hour period within the furnace
  • Gravity and convection currents facilitate optimum blending of materials

STEP 3: Forming

  • Gobs are formed, cut and delivered into the blank mold
  • The vial is formed using Press & blow process or Blow & Blow process
  • In both case, the vial is formed in 2 steps:
    • A preform or blank and the neck is formed
    • The blank is transferred to the finished mold to form the finished vial
  • Fully automated, the IS forming machines are equipped with multiple stations to form from 4 up-to 48 vials per cycle.
  • After forming, all vials are controlled and pass through annealing lehr to release glass mechanical stress

STEP 4: Inspection in the clean room

  • Once formed and cooled, 100% of  the vials and bottles are inspected in a clean room environment to control:
    • Dimensions, including wall thickness and diameters
    • Glass Integrity
    • Seal and bottle Integrity
    • Neck and bottom inspection
    • Defaults such as chipped glass, blister, distorsion, finish distorsion affecting tightness

STEP 5: Packing

  • Before packing, all vials and bottles are turned upside down and blown in the clean room to minimize risk of loose particles presence.
  • Shrink-wrap packs are formed inside the clean room for maximum cleanliness.
  • Automated Palletization offers consistency and avoid human manipulation with the vials.

STEP 6: Release

  • Each label contains data critical for complete traceability.
  • Batch release is based on manufacturing track records and QC results.
  • SGD Pharma systematically issues compliance certificates with each delivery.
Visual identifier
molded
Weight
1