Pro-Aseptic powder filling Machine -cGMP.

Pro-Aseptic powder filling Machine -cGMP.

  • Is considered one of the basic equipment in the sterile pharmaceutical industries and is intended for filling preparations intended for injection (Vials, intravenous solutions  ,etc…).
  • Rotary, designed so that the filling and closing processes are achieved within one space (one structure), where the filling process takes place in a section completely separate from the closing process section to protect the product from metal particles resulting from the closing process to ensure that the product is filled aseptically in accordance with cGMP requirements.
  • The first section is sterile by using Laminar Flow, in which the filling process and the rubber seal are placed.
  • The second section (completely separated from the filling process section) is where the process of placing the metal cap on the vials takes place.
  • The rubber seal feeder and the metal cap feeder are both under sterile space by Laminar Flow.
  • All points welded by TIG & ORBITAL polished and treated.
  • Product contact parts made of SS (316 L)  and Teflon and non-contact parts made of SS ( 304 ) resistant plastic (Polyamide) and aluminum .
  • Interior surface is a mirror finishing & exterior surface is a Matt finishing .

 

Description

Pro-Aseptic powder filling Machine’s main parts:

  • A fixed table to receive vials from the Previous sterilization stage.
  • Rotating tray .
  • Rotating star: equipped with Container centers.
  • Nitrogen pump head- stage 1
  • Balance tank with level sensor and VENT bacterial filter to ensure a continuous and regular flow of preparations during the filling process.
  • Filling head via a peristaltic pump (silicone treated with Platinum tube pump) and the filling range can be calibrated via the LCD screen.
  • Packaging takes place in two stages per vial to increase production capacity and save time.
  • Nitrogen pump head- stage 2
  • Rubber seal feeder.
  • Metal cap feeder.
  • Metal lid closing mechanism
  • Conveyor belt for ejecting the vials :Driven by a motor and speed reducer encased in a stainless steel cover in accordance with cGMP requirements

Technical Data

  • The Aseptic powder filling Machine featured by high efficiency, ease of use and low maintenance.
  • It is designed and manufactured in accordance with international quality systems.
  • The production capacity varies depending on the type and density of the product.
  • It can be designed to meet exact customer requirements.