This machine is suitable for large volume plastic container parenteral production up to 1000ml. It is mainly used to fill aseptic injectable liquid IV solutions. The material is FDA approved and is reusable. Machine has low waste and high stability.
1.Machine separation between filling and mechanical side (dark/white side technology).
2.Grade A air shower at point of fill and aseptic design (CIP/SIP).
3. Applicable to both PP&PE material
3. Capping options suitable for global standard.
5.FDA CFR21 Part11 compliant.
6.In-house container development, prototyping, and contract manufacturing.
The Blow-Fill-Seal Technique has been developed so that formation of the container, filling and sealing takes place in a single machine under a controlled environment that enables the packaging of a pharmaceutical liquid in an aseptic manner.
The following picture show the major phases in the integrated packaging of parenthetical solutions using the AFP System.
Aseptic packaging process:
As the container is made, filled and sealed within a single machine and the process is protected using a sterile air shower and additionally, all process media (solution, air etc.) are sterile filtered, the chance of contamination is very remote. Adding to the fact that during the whole cycle, open containers remain exposed to the clean room air for less than 1.5 seconds, the Blow-Fill-Seal technology becomes the process of choice where contamination of particle matter and microbial contamination is a primary concern.