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Project

Aseptic Syringe Filling Isolator System

Year

2020

Location

USA

Description

One Sterile Multi-Chamber Syringe Filling Line for a Pilot scale filling line. The units are specifically designed to provide product protection during the production operations. The Isolator main chambers are designed with recirculatory unidirectional airflow. The transfer chamber will incorporate its own fan units and filter system so it can be operated and bio-decontaminated independently of the main chamber. This will allow extra equipment to be introduced, decontaminated and removed into/out of the main chamber whilst in operation.

Scope

1 x Sterile Multi-Chamber Syringe Filling Line comprising:

  • 2 x working main chambers with 1 x transfer chamber
  • +ve pressure aseptic process environment with an internal air cleanliness of ISO Class 4.8 (grade A)
  • Filling equipment integrated into the Isolator floor
  • Integral Telstar ionHP+ bio-decontamination system
  • Viable / Non-viable monitoring equipment
  • RFID Glove tester
  • Temperature and RH system controlling humidity to <3%RH